Cognitive Function, Height, Weight Gain
Conditions
Keywords
Dietary Supplement, Growth and Development
Brief summary
A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.
Interventions
DIETARY_SUPPLEMENTNuBest Tall Growth Protein Powder
NuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes.
DIETARY_SUPPLEMENTPlacebo Powder
The placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients.
Sponsors
Citruslabs
NuBest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study is double-blind; participants, care providers, investigators, and outcomes assessors are all masked to the allocation of intervention or placebo.
Intervention model description
A randomized, double-blind, placebo-controlled, two-arm trial.
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Interested in their child trialing a dietary supplement designed to improve overall health outcomes in children including height, maintenance of a healthy weight, cognitive function, immune function, and energy levels. * Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of any kind for the duration of the study. * Parents willing to weigh and measure the height of their child throughout the study. * Generally healthy - do not have any uncontrolled chronic disease.
Exclusion criteria
* Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, digestive disease, or skeletal dysplasia. * Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * Is undergoing or planning to undergo significant medical procedures in the next six months. * A history of severe allergic reactions, including but not limited to any of the product's ingredients. * Any child with a dairy allergy or lactose intolerance. * Has undergone any surgeries or invasive treatments in the last six months. * Has had any major illness in the last three months. * Having any planned invasive medical procedures during the study period. * Currently participating in any other clinical study. * Unwilling to follow the study protocol. * Any child diagnosed with attention-deficit disorder (ADD) or attention-deficit hyperactivity disorder (ADHD). * Any child currently taking or have taken in the last 3 months any prescription medication targeting ADD or ADHD (such as Adderall, Concerta, Focalin, Evekeo, or Ritalin). * Any child that is a 'fussy' eater or who the parent suspects may not tolerate consuming the test product daily for six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Mean Percentile Score in Double Trouble | Baseline and Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| IChange Mean Percentile Score in Feature Match | Baseline and Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Grammatical Reasoning | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Digit Span | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Token Search | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child's Energy Levels as Reported by Parents | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor, 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. |
| Changes in Limitations When Completing High-Intensity Activity | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter. |
| Changes in Limitations When Completing Moderate-Intensity Activity | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter. |
| Changes in Limitations When Moving Around | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter. |
| Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Limitations When Bending, Lifting, or Stooping. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Limitations During the Completion of Schoolwork or Activities. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Parents' Perception of Child's Health Compared to Other Children. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement My child seems less healthy than other children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Parents' Perception of Child's Immunity | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement When something is going around my child usually catches it. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Parents' Worry About Child's Health | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement I worry more about my child's health than other parents do their children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Parent-reported Frequency of Child's Stomach Aches | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. |
| Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis) | Baseline to Month 6 | This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test. |
| Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response. |
| Increase in Height - Nubest Group Only (Within-Group Analysis) | Baseline to Month 6 | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. |
| Increase in Height - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. |
| Changes in Weight - Nubest Group Only (Within-Group Analysis) | Baseline to Month 6 | Weight measurement will be taken using a FitBit Smart Scale. |
| Changes in Weight - Placebo Group Only (Within-Group Analysis) | Baseline to Month 6 | Weight measurement will be taken using a FitBit Smart Scale. |
| Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6. | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6. | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement My child seems less healthy than other children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement When something is going around my child usually catches it. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement I worry more about my child's health than other parents do their children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only. |
| Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only. |
| Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | Hide Description: This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Increase in Height | Baseline, Month 2, Month 4, and Month 6 | Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study. |
| Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement When something is going around my child usually catches it. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement I worry more about my child's health than other parents do their children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only. |
| Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement My child seems less healthy than other children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only. |
| Changes in Weight | Baseline, Month 2, Month 4, and Month 6 | Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups. |
| Changes in Overall Health as Reported by Parents | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. |
| Change in Parents' Perception of the Child's Health in the Future. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire, with the question I expect my child will have a very healthy life. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter. |
| Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Monthly from Baseline to Month 6 | This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Much worse, 5 = Much Better). An increase in the mean score is associated with improvement in this parameter. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months (n=30). | 30 |
| Placebo Arm Participants in this arm will take a placebo product daily for 6 months (n=30). | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo Arm | Total | Intervention Arm |
|---|---|---|---|
| Age, Continuous | 12.14 years STANDARD_DEVIATION 2.26 | 12.64 years STANDARD_DEVIATION 2.08 | 13.19 years STANDARD_DEVIATION 1.75 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 18 Participants | 28 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 32 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change Mean Percentile Score in Digit Span
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Digit Span | 28.02 percent change from baseline | Standard Deviation 60.29 |
| Placebo Arm | Change Mean Percentile Score in Digit Span | 19.69 percent change from baseline | Standard Deviation 69.38 |
p-value: 0.919209t-test, 2 sided
Primary
Change Mean Percentile Score in Double Trouble
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline and Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Double Trouble | 168.55 percent change from baseline | Standard Deviation 230.4 |
| Placebo Arm | Change Mean Percentile Score in Double Trouble | 129.46 percent change from baseline | Standard Deviation 332.76 |
p-value: 0.488445Multiple t-tests
Primary
Change Mean Percentile Score in Grammatical Reasoning
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Grammatical Reasoning | 56.59 percent change from baseline | Standard Deviation 130.07 |
| Placebo Arm | Change Mean Percentile Score in Grammatical Reasoning | 88.39 percent change from baseline | Standard Deviation 214.99 |
p-value: 0.98317t-test, 2 sided
Primary
Change Mean Percentile Score in Token Search
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Token Search | 6.26 percent change from baseline | Standard Deviation 36.38 |
| Placebo Arm | Change Mean Percentile Score in Token Search | 40.20 percent change from baseline | Standard Deviation 145.02 |
p-value: 0.919209t-test, 2 sided
Primary
IChange Mean Percentile Score in Feature Match
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline and Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | IChange Mean Percentile Score in Feature Match | 34.60 percent change from baseline | Standard Deviation 67.93 |
| Placebo Arm | IChange Mean Percentile Score in Feature Match | 58.20 percent change from baseline | Standard Deviation 147.2 |
p-value: 0.98317t-test, 2 sided
Secondary
Change in Child's Energy Levels as Reported by Parents
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor, 5 = Excellent). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents | Month 1 | 9.17 percent change from baseline | Standard Deviation 18.2 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents | Month 2 | 5.83 percent change from baseline | Standard Deviation 18.69 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents | Month 3 | 11.86 percent change from baseline | Standard Deviation 16.02 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents | Month 4 | 18.75 percent change from baseline | Standard Deviation 24.85 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents | Month 5 | 15.14 percent change from baseline | Standard Deviation 23.86 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents | Month 6 | 16.53 percent change from baseline | Standard Deviation 31.79 |
| Placebo Arm | Change in Child's Energy Levels as Reported by Parents | Month 5 | 27.61 percent change from baseline | Standard Deviation 65.04 |
| Placebo Arm | Change in Child's Energy Levels as Reported by Parents | Month 1 | 11.47 percent change from baseline | Standard Deviation 51.5 |
| Placebo Arm | Change in Child's Energy Levels as Reported by Parents | Month 4 | 26.32 percent change from baseline | Standard Deviation 66.6 |
| Placebo Arm | Change in Child's Energy Levels as Reported by Parents | Month 2 | 13.20 percent change from baseline | Standard Deviation 20.34 |
| Placebo Arm | Change in Child's Energy Levels as Reported by Parents | Month 6 | 15.95 percent change from baseline | Standard Deviation 28.48 |
| Placebo Arm | Change in Child's Energy Levels as Reported by Parents | Month 3 | 26.88 percent change from baseline | Standard Deviation 47.45 |
p-value: 0.999835t-test, 2 sided
p-value: 0.962016t-test, 2 sided
p-value: 0.995044t-test, 2 sided
p-value: 0.998665t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: 0.999567t-test, 2 sided
Secondary
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Baseline | 3.88 score on a scale | Standard Deviation 0.8 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 1 | 4.21 score on a scale | Standard Deviation 0.66 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 2 | 4.04 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 3 | 4.29 score on a scale | Standard Deviation 0.69 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 4 | 4.46 score on a scale | Standard Deviation 0.59 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 5 | 4.33 score on a scale | Standard Deviation 0.64 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 6 | 4.38 score on a scale | Standard Deviation 0.65 |
p-value: 0.0384t-test, 2 sided
p-value: 0.6328t-test, 2 sided
p-value: 0.0026t-test, 2 sided
p-value: 0.0012t-test, 2 sided
p-value: 0.0118t-test, 2 sided
p-value: 0.0221t-test, 2 sided
Secondary
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Baseline | 3.86 score on a scale | Standard Deviation 0.73 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 1 | 3.95 score on a scale | Standard Deviation 0.67 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 2 | 4.29 score on a scale | Standard Deviation 0.64 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 3 | 4.33 score on a scale | Standard Deviation 0.66 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 4 | 4.10 score on a scale | Standard Deviation 0.7 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 5 | 4.29 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 6 | 4.33 score on a scale | Standard Deviation 0.66 |
p-value: 0.9821t-test, 2 sided
p-value: 0.0403t-test, 2 sided
p-value: 0.0638t-test, 2 sided
p-value: 0.7195t-test, 2 sided
p-value: 0.1856t-test, 2 sided
p-value: 0.1222t-test, 2 sided
Secondary
Change in Limitations During the Completion of Schoolwork or Activities.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 1 | 5.77 percent change from baseline | Standard Deviation 29.42 |
| Intervention Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 2 | 9.62 percent change from baseline | Standard Deviation 60.03 |
| Intervention Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 3 | 3.85 percent change from baseline | Standard Deviation 31.38 |
| Intervention Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 4 | -6.25 percent change from baseline | Standard Deviation 16.89 |
| Intervention Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 5 | 2.08 percent change from baseline | Standard Deviation 45.39 |
| Intervention Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 6 | -6.00 percent change from baseline | Standard Deviation 16.58 |
| Placebo Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 5 | -13.04 percent change from baseline | Standard Deviation 26.09 |
| Placebo Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 1 | -0.64 percent change from baseline | Standard Deviation 65.06 |
| Placebo Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 4 | -12.50 percent change from baseline | Standard Deviation 23.7 |
| Placebo Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 2 | -2.00 percent change from baseline | Standard Deviation 37.37 |
| Placebo Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 6 | -14.29 percent change from baseline | Standard Deviation 27.02 |
| Placebo Arm | Change in Limitations During the Completion of Schoolwork or Activities. | Month 3 | -13.04 percent change from baseline | Standard Deviation 26.09 |
p-value: 0.795476t-test, 2 sided
p-value: 0.977286t-test, 2 sided
p-value: 0.559556t-test, 2 sided
p-value: 0.997753t-test, 2 sided
p-value: 0.952378t-test, 2 sided
p-value: 0.988108t-test, 2 sided
Secondary
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 1 | 19.23 percent change from baseline | Standard Deviation 51.14 |
| Intervention Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 2 | 0.00 percent change from baseline | Standard Deviation 24.49 |
| Intervention Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 3 | 7.69 percent change from baseline | Standard Deviation 36.58 |
| Intervention Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 4 | -6.25 percent change from baseline | Standard Deviation 16.89 |
| Intervention Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 5 | 2.08 percent change from baseline | Standard Deviation 45.39 |
| Intervention Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 6 | -6.00 percent change from baseline | Standard Deviation 16.58 |
| Placebo Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 5 | -9.42 percent change from baseline | Standard Deviation 21.8 |
| Placebo Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 1 | -5.13 percent change from baseline | Standard Deviation 56.13 |
| Placebo Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 4 | -10.76 percent change from baseline | Standard Deviation 23.11 |
| Placebo Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 2 | -3.00 percent change from baseline | Standard Deviation 37.64 |
| Placebo Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 6 | -7.14 percent change from baseline | Standard Deviation 35.19 |
| Placebo Arm | Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities. | Month 3 | -9.78 percent change from baseline | Standard Deviation 20.82 |
p-value: 0.987949t-test, 2 sided
p-value: 0.576782t-test, 2 sided
p-value: 0.998665t-test, 2 sided
p-value: 0.989226t-test, 2 sided
p-value: 0.999567t-test, 2 sided
p-value: 0.55783t-test, 2 sided
Secondary
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 1 | 5.77 percent change from baseline | Standard Deviation 29.42 |
| Intervention Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 2 | 5.77 percent change from baseline | Standard Deviation 29.42 |
| Intervention Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 3 | 1.92 percent change from baseline | Standard Deviation 22.27 |
| Intervention Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 4 | -4.17 percent change from baseline | Standard Deviation 14.12 |
| Intervention Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 5 | 4.17 percent change from baseline | Standard Deviation 44.03 |
| Intervention Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 6 | -4.00 percent change from baseline | Standard Deviation 13.84 |
| Placebo Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 5 | -9.42 percent change from baseline | Standard Deviation 21.8 |
| Placebo Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 1 | -0.96 percent change from baseline | Standard Deviation 53.56 |
| Placebo Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 4 | -10.42 percent change from baseline | Standard Deviation 21.88 |
| Placebo Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 2 | -4.00 percent change from baseline | Standard Deviation 29.38 |
| Placebo Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 6 | -7.14 percent change from baseline | Standard Deviation 35.19 |
| Placebo Arm | Change in Limitations in the Kind of Schoolwork or Activities Undertaken. | Month 3 | -5.43 percent change from baseline | Standard Deviation 30.94 |
p-value: 0.981906t-test, 2 sided
p-value: 0.945027t-test, 2 sided
p-value: 0.767795t-test, 2 sided
p-value: 0.996139t-test, 2 sided
p-value: 0.952378t-test, 2 sided
p-value: 0.998846t-test, 2 sided
Secondary
Change in Limitations When Bending, Lifting, or Stooping.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 1 | 5.77 percent change from baseline | Standard Deviation 29.42 |
| Intervention Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 2 | 3.85 percent change from baseline | Standard Deviation 31.38 |
| Intervention Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 3 | -3.85 percent change from baseline | Standard Deviation 13.59 |
| Intervention Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 4 | -2.08 percent change from baseline | Standard Deviation 10.21 |
| Intervention Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 5 | 6.25 percent change from baseline | Standard Deviation 42.51 |
| Intervention Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 6 | -2.00 percent change from baseline | Standard Deviation 10 |
| Placebo Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 5 | -6.52 percent change from baseline | Standard Deviation 17.22 |
| Placebo Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 1 | 6.41 percent change from baseline | Standard Deviation 54.79 |
| Placebo Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 4 | 2.78 percent change from baseline | Standard Deviation 44.69 |
| Placebo Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 2 | 0.67 percent change from baseline | Standard Deviation 34.52 |
| Placebo Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 6 | 0.00 percent change from baseline | Standard Deviation 27.39 |
| Placebo Arm | Change in Limitations When Bending, Lifting, or Stooping. | Month 3 | -1.45 percent change from baseline | Standard Deviation 27.02 |
p-value: 0.999975t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.999801t-test, 2 sided
p-value: 0.999984t-test, 2 sided
p-value: 0.960874t-test, 2 sided
p-value: 0.999567t-test, 2 sided
Secondary
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 1 | -6.79 percent change from baseline | Standard Deviation 28.89 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 2 | -10.19 percent change from baseline | Standard Deviation 29.11 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 3 | -18.21 percent change from baseline | Standard Deviation 22.79 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 4 | -21.53 percent change from baseline | Standard Deviation 23.3 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 5 | -17.01 percent change from baseline | Standard Deviation 36.98 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 6 | -21.00 percent change from baseline | Standard Deviation 39.32 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 5 | -15.58 percent change from baseline | Standard Deviation 36.44 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 1 | -7.05 percent change from baseline | Standard Deviation 39.91 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 4 | -10.42 percent change from baseline | Standard Deviation 33.27 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 2 | -7.00 percent change from baseline | Standard Deviation 38.32 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 6 | -3.57 percent change from baseline | Standard Deviation 37.69 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet | Month 3 | -11.96 percent change from baseline | Standard Deviation 37.17 |
p-value: >0.999999t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.999801t-test, 2 sided
p-value: 0.963236t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: 0.737995t-test, 2 sided
Secondary
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Baseline | 2.33 score on a scale | Standard Deviation 0.92 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Month 1 | 2.13 score on a scale | Standard Deviation 0.8 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.96 score on a scale | Standard Deviation 0.62 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.79 score on a scale | Standard Deviation 0.66 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.71 score on a scale | Standard Deviation 0.62 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.71 score on a scale | Standard Deviation 0.62 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.63 score on a scale | Standard Deviation 0.58 |
p-value: >0.9999t-test, 2 sided
p-value: 0.6983t-test, 2 sided
p-value: 0.1062t-test, 2 sided
p-value: 0.0333t-test, 2 sided
p-value: 0.0734t-test, 2 sided
p-value: 0.0219t-test, 2 sided
Secondary
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Baseline | 1.90 score on a scale | Standard Deviation 0.94 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.81 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.71 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.52 score on a scale | Standard Deviation 0.68 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.57 score on a scale | Standard Deviation 0.68 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.48 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.67 score on a scale | Standard Deviation 0.73 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.9188t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.3503t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Change in Parent-reported Frequency of Child's Stomach Aches
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 2 | -7.69 percent change from baseline | Standard Deviation 28.37 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 4 | -6.25 percent change from baseline | Standard Deviation 31.4 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 1 | -4.49 percent change from baseline | Standard Deviation 26.48 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 5 | -13.19 percent change from baseline | Standard Deviation 34.4 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 3 | -10.26 percent change from baseline | Standard Deviation 24.98 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 6 | -19.33 percent change from baseline | Standard Deviation 31.8 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 3 | -7.97 percent change from baseline | Standard Deviation 51.46 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 1 | -9.62 percent change from baseline | Standard Deviation 33.72 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 2 | -11.00 percent change from baseline | Standard Deviation 30.12 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 6 | -12.70 percent change from baseline | Standard Deviation 35.32 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 4 | -11.11 percent change from baseline | Standard Deviation 37 |
| Placebo Arm | Change in Parent-reported Frequency of Child's Stomach Aches | Month 5 | -9.42 percent change from baseline | Standard Deviation 32.5 |
p-value: 0.999851t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.999801t-test, 2 sided
p-value: 0.998467t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: 0.998846t-test, 2 sided
Secondary
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Baseline | 2.42 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Month 1 | 2.17 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Month 2 | 2.13 score on a scale | Standard Deviation 0.54 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Month 3 | 2.08 score on a scale | Standard Deviation 0.65 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Month 4 | 2.13 score on a scale | Standard Deviation 0.61 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.92 score on a scale | Standard Deviation 0.5 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.88 score on a scale | Standard Deviation 0.61 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.8495t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.1951t-test, 2 sided
p-value: 0.0806t-test, 2 sided
Secondary
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Baseline | 2.24 score on a scale | Standard Deviation 0.77 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Month 1 | 2.05 score on a scale | Standard Deviation 0.74 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.90 score on a scale | Standard Deviation 0.7 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.81 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.90 score on a scale | Standard Deviation 1 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.86 score on a scale | Standard Deviation 0.79 |
| Intervention Arm | Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.81 score on a scale | Standard Deviation 0.68 |
p-value: >0.9999t-test, 2 sided
p-value: 0.7477t-test, 2 sided
p-value: 0.297t-test, 2 sided
p-value: 0.3503t-test, 2 sided
p-value: 0.297t-test, 2 sided
p-value: 0.4449t-test, 2 sided
Secondary
Change in Parents' Perception of Child's Health Compared to Other Children.
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement My child seems less healthy than other children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 1 | -1.92 percent change from baseline | Standard Deviation 46.27 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 2 | 2.56 percent change from baseline | Standard Deviation 68.91 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 3 | -16.67 percent change from baseline | Standard Deviation 24.49 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 4 | -12.50 percent change from baseline | Standard Deviation 34.49 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 5 | -2.08 percent change from baseline | Standard Deviation 45.92 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 6 | 0.00 percent change from baseline | Standard Deviation 43.83 |
| Placebo Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 5 | 15.22 percent change from baseline | Standard Deviation 80.55 |
| Placebo Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 1 | 1.60 percent change from baseline | Standard Deviation 47.61 |
| Placebo Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 4 | 0.00 percent change from baseline | Standard Deviation 46.88 |
| Placebo Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 2 | -4.00 percent change from baseline | Standard Deviation 32.38 |
| Placebo Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 6 | 8.73 percent change from baseline | Standard Deviation 52.6 |
| Placebo Arm | Change in Parents' Perception of Child's Health Compared to Other Children. | Month 3 | 1.45 percent change from baseline | Standard Deviation 53.16 |
p-value: 0.995367t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.974102t-test, 2 sided
p-value: 0.998665t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: 0.999567t-test, 2 sided
Secondary
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement My child seems less healthy than other children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Baseline | 1.71 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.46 score on a scale | Standard Deviation 0.59 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.54 score on a scale | Standard Deviation 0.83 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.29 score on a scale | Standard Deviation 0.46 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.33 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.46 score on a scale | Standard Deviation 0.51 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.50 score on a scale | Standard Deviation 0.51 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.3682t-test, 2 sided
p-value: 0.6098t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement My child seems less healthy than other children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Baseline | 1.48 score on a scale | Standard Deviation 0.6 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.57 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.38 score on a scale | Standard Deviation 0.59 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.43 score on a scale | Standard Deviation 0.6 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.48 score on a scale | Standard Deviation 0.6 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.52 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.43 score on a scale | Standard Deviation 0.6 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Change in Parents' Perception of Child's Immunity
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement When something is going around my child usually catches it. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of Child's Immunity | Month 1 | -5.77 percent change from baseline | Standard Deviation 12.19 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity | Month 2 | -11.86 percent change from baseline | Standard Deviation 21.37 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity | Month 3 | -8.01 percent change from baseline | Standard Deviation 25.22 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity | Month 4 | -9.72 percent change from baseline | Standard Deviation 18.17 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity | Month 5 | -12.85 percent change from baseline | Standard Deviation 29.69 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity | Month 6 | -9.00 percent change from baseline | Standard Deviation 31.91 |
| Placebo Arm | Change in Parents' Perception of Child's Immunity | Month 5 | -3.99 percent change from baseline | Standard Deviation 31.97 |
| Placebo Arm | Change in Parents' Perception of Child's Immunity | Month 1 | 18.59 percent change from baseline | Standard Deviation 73.34 |
| Placebo Arm | Change in Parents' Perception of Child's Immunity | Month 4 | 5.56 percent change from baseline | Standard Deviation 53.26 |
| Placebo Arm | Change in Parents' Perception of Child's Immunity | Month 2 | 1.33 percent change from baseline | Standard Deviation 25.76 |
| Placebo Arm | Change in Parents' Perception of Child's Immunity | Month 6 | -1.98 percent change from baseline | Standard Deviation 38.54 |
| Placebo Arm | Change in Parents' Perception of Child's Immunity | Month 3 | 12.68 percent change from baseline | Standard Deviation 54.98 |
p-value: 0.882016t-test, 2 sided
p-value: 0.860406t-test, 2 sided
p-value: 0.958944t-test, 2 sided
p-value: 0.998816t-test, 2 sided
p-value: 0.989226t-test, 2 sided
p-value: 0.999296t-test, 2 sided
Secondary
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement When something is going around my child usually catches it. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Baseline | 2.38 score on a scale | Standard Deviation 0.65 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Month 1 | 2.21 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Month 2 | 2.00 score on a scale | Standard Deviation 0.42 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Month 3 | 2.13 score on a scale | Standard Deviation 0.54 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Month 4 | 2.13 score on a scale | Standard Deviation 0.61 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Month 5 | 2.04 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis) | Month 6 | 2.08 score on a scale | Standard Deviation 0.65 |
p-value: >0.9999t-test, 2 sided
p-value: 0.5691t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.6983t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement When something is going around my child usually catches it. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Baseline | 2.24 score on a scale | Standard Deviation 0.89 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Month 1 | 2.24 score on a scale | Standard Deviation 0.62 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Month 2 | 2.19 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Month 3 | 2.19 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Month 4 | 2.14 score on a scale | Standard Deviation 0.73 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Month 5 | 2.00 score on a scale | Standard Deviation 0.71 |
| Intervention Arm | Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis) | Month 6 | 2.05 score on a scale | Standard Deviation 0.86 |
p-value: >0.9999t-test, 2 sided
p-value: 0.9951t-test, 2 sided
p-value: 0.999t-test, 2 sided
p-value: 0.9913t-test, 2 sided
p-value: 0.4517t-test, 2 sided
p-value: 0.8187t-test, 2 sided
Secondary
Change in Parents' Perception of the Child's Health in the Future.
This parameter was assessed using a parent-completed questionnaire, with the question I expect my child will have a very healthy life. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 1 | 16.99 percent change from baseline | Standard Deviation 60.8 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 2 | 19.87 percent change from baseline | Standard Deviation 62.14 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 3 | 19.55 percent change from baseline | Standard Deviation 60.73 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 4 | 18.06 percent change from baseline | Standard Deviation 67.82 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 5 | 20.83 percent change from baseline | Standard Deviation 62.55 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 6 | 18.67 percent change from baseline | Standard Deviation 61.44 |
| Placebo Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 5 | 8.33 percent change from baseline | Standard Deviation 25 |
| Placebo Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 1 | 3.53 percent change from baseline | Standard Deviation 32.93 |
| Placebo Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 4 | 4.86 percent change from baseline | Standard Deviation 22.1 |
| Placebo Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 2 | 7.33 percent change from baseline | Standard Deviation 30.17 |
| Placebo Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 6 | 8.33 percent change from baseline | Standard Deviation 27.13 |
| Placebo Arm | Change in Parents' Perception of the Child's Health in the Future. | Month 3 | 9.78 percent change from baseline | Standard Deviation 25.46 |
p-value: 0.999851t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.999801t-test, 2 sided
p-value: 0.999984t-test, 2 sided
p-value: 0.993223t-test, 2 sided
p-value: 0.999567t-test, 2 sided
Secondary
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Baseline | 3.38 score on a scale | Standard Deviation 0.77 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Month 1 | 3.63 score on a scale | Standard Deviation 0.49 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Month 2 | 3.71 score on a scale | Standard Deviation 0.46 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Month 3 | 3.67 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Month 4 | 3.58 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Month 5 | 3.71 score on a scale | Standard Deviation 0.46 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis) | Month 6 | 3.67 score on a scale | Standard Deviation 0.48 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Hide Description: This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Baseline | 3.48 score on a scale | Standard Deviation 0.6 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Month 1 | 3.43 score on a scale | Standard Deviation 0.6 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Month 2 | 3.48 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Month 3 | 3.62 score on a scale | Standard Deviation 0.5 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Month 4 | 3.62 score on a scale | Standard Deviation 0.5 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Month 5 | 3.62 score on a scale | Standard Deviation 0.5 |
| Intervention Arm | Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis) | Month 6 | 3.67 score on a scale | Standard Deviation 0.58 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Change in Parents' Worry About Child's Health
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement I worry more about my child's health than other parents do their children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Worry About Child's Health | Month 1 | 7.37 percent change from baseline | Standard Deviation 69.77 |
| Intervention Arm | Change in Parents' Worry About Child's Health | Month 2 | 12.18 percent change from baseline | Standard Deviation 51.71 |
| Intervention Arm | Change in Parents' Worry About Child's Health | Month 3 | 2.24 percent change from baseline | Standard Deviation 55.81 |
| Intervention Arm | Change in Parents' Worry About Child's Health | Month 4 | 4.86 percent change from baseline | Standard Deviation 67.25 |
| Intervention Arm | Change in Parents' Worry About Child's Health | Month 5 | 10.76 percent change from baseline | Standard Deviation 55.3 |
| Intervention Arm | Change in Parents' Worry About Child's Health | Month 6 | 1.33 percent change from baseline | Standard Deviation 52.63 |
| Placebo Arm | Change in Parents' Worry About Child's Health | Month 5 | 2.54 percent change from baseline | Standard Deviation 60.59 |
| Placebo Arm | Change in Parents' Worry About Child's Health | Month 1 | -9.29 percent change from baseline | Standard Deviation 31.83 |
| Placebo Arm | Change in Parents' Worry About Child's Health | Month 4 | -1.39 percent change from baseline | Standard Deviation 48.94 |
| Placebo Arm | Change in Parents' Worry About Child's Health | Month 2 | 1.33 percent change from baseline | Standard Deviation 56.91 |
| Placebo Arm | Change in Parents' Worry About Child's Health | Month 6 | -7.94 percent change from baseline | Standard Deviation 57.4 |
| Placebo Arm | Change in Parents' Worry About Child's Health | Month 3 | 1.45 percent change from baseline | Standard Deviation 40.8 |
p-value: 0.999975t-test, 2 sided
p-value: 0.977286t-test, 2 sided
p-value: 0.999t-test, 2 sided
p-value: 0.999984t-test, 2 sided
p-value: 0.986557t-test, 2 sided
p-value: 0.998367t-test, 2 sided
Secondary
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement I worry more about my child's health than other parents do their children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Baseline | 2.38 score on a scale | Standard Deviation 0.92 |
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Month 1 | 2.17 score on a scale | Standard Deviation 0.7 |
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Month 2 | 2.38 score on a scale | Standard Deviation 0.65 |
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Month 3 | 2.13 score on a scale | Standard Deviation 0.68 |
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Month 4 | 2.08 score on a scale | Standard Deviation 0.58 |
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Month 5 | 2.33 score on a scale | Standard Deviation 0.82 |
| Intervention Arm | Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis) | Month 6 | 2.21 score on a scale | Standard Deviation 0.78 |
p-value: 0.819t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.5749t-test, 2 sided
p-value: 0.4873t-test, 2 sided
p-value: 0.9998t-test, 2 sided
p-value: 0.819t-test, 2 sided
Secondary
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement I worry more about my child's health than other parents do their children. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Baseline | 2.24 score on a scale | Standard Deviation 0.89 |
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Month 1 | 2.19 score on a scale | Standard Deviation 1.03 |
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Month 2 | 2.10 score on a scale | Standard Deviation 1 |
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Month 3 | 2.19 score on a scale | Standard Deviation 1.03 |
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Month 4 | 2.14 score on a scale | Standard Deviation 1.01 |
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Month 5 | 2.05 score on a scale | Standard Deviation 0.8 |
| Intervention Arm | Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.90 score on a scale | Standard Deviation 1.09 |
p-value: 0.998t-test, 2 sided
p-value: 0.9591t-test, 2 sided
p-value: 0.9994t-test, 2 sided
p-value: 0.9936t-test, 2 sided
p-value: 0.8526t-test, 2 sided
p-value: 0.4375t-test, 2 sided
Secondary
Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis) | Baseline | 42.29 percentile score | Standard Deviation 14.33 |
| Intervention Arm | Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis) | Month 6 | 50.88 percentile score | Standard Deviation 22.66 |
p-value: 0.2137t-test, 2 sided
Secondary
Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis) | Baseline | 52.57 percentile score | Standard Deviation 14.7 |
| Intervention Arm | Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis) | Month 6 | 57.62 percentile score | Standard Deviation 22.36 |
p-value: 0.6088t-test, 2 sided
Secondary
Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)
This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis) | Baseline | 28 percentile score | Standard Deviation 22.46 |
| Intervention Arm | Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis) | Month 6 | 48.67 percentile score | Standard Deviation 27.18 |
p-value: 0.0003t-test, 2 sided
Secondary
Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis) | Baseline | 33.73 percentile score | Standard Deviation 18.98 |
| Intervention Arm | Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis) | Month 6 | 49.62 percentile score | Standard Deviation 28.48 |
p-value: 0.239t-test, 2 sided
Secondary
Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis) | Baseline | 39.58 percentile score | Standard Deviation 17.86 |
| Intervention Arm | Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis) | Month 6 | 45.75 percentile score | Standard Deviation 15.26 |
p-value: 0.2698t-test, 2 sided
Secondary
Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis) | Baseline | 40.81 percentile score | Standard Deviation 19.49 |
| Intervention Arm | Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis) | Month 6 | 45.29 percentile score | Standard Deviation 22.87 |
p-value: 0.6088t-test, 2 sided
Secondary
Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis) | Baseline | 47.42 percentile score | Standard Deviation 24.42 |
| Intervention Arm | Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis) | Month 6 | 56.54 percentile score | Standard Deviation 28.46 |
p-value: 0.2698t-test, 2 sided
Secondary
Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis) | Baseline | 47.05 percentile score | Standard Deviation 25.36 |
| Intervention Arm | Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis) | Month 6 | 54.33 percentile score | Standard Deviation 32.05 |
p-value: 0.5738t-test, 2 sided
Secondary
Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis) | Baseline | 53.17 percentile score | Standard Deviation 17.2 |
| Intervention Arm | Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis) | Month 6 | 53.04 percentile score | Standard Deviation 14.44 |
p-value: 0.8639t-test, 2 sided
Secondary
Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis) | Baseline | 48.62 percentile score | Standard Deviation 18.5 |
| Intervention Arm | Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis) | Month 6 | 55.62 percentile score | Standard Deviation 21.08 |
p-value: 0.4942t-test, 2 sided
Secondary
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Baseline | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.17 score on a scale | Standard Deviation 0.38 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.21 score on a scale | Standard Deviation 0.66 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Baseline | 1.48 score on a scale | Standard Deviation 0.87 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.24 score on a scale | Standard Deviation 0.54 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.29 score on a scale | Standard Deviation 0.64 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.10 score on a scale | Standard Deviation 0.44 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.05 score on a scale | Standard Deviation 0.22 |
| Intervention Arm | Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.05 score on a scale | Standard Deviation 0.22 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: 0.982t-test, 2 sided
Secondary
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Baseline | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.25 score on a scale | Standard Deviation 0.53 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.17 score on a scale | Standard Deviation 0.38 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Baseline | 1.43 score on a scale | Standard Deviation 0.93 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.19 score on a scale | Standard Deviation 0.51 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.10 score on a scale | Standard Deviation 0.3 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Baseline | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Baseline | 1.43 score on a scale | Standard Deviation 0.93 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.19 score on a scale | Standard Deviation 0.51 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.19 score on a scale | Standard Deviation 0.68 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.10 score on a scale | Standard Deviation 0.3 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Baseline | 1.04 score on a scale | Standard Deviation 0.2 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Baseline | 1.24 score on a scale | Standard Deviation 0.7 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.14 score on a scale | Standard Deviation 0.36 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.19 score on a scale | Standard Deviation 0.51 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.05 score on a scale | Standard Deviation 0.22 |
| Intervention Arm | Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.14 score on a scale | Standard Deviation 0.36 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Completing High-Intensity Activity
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity | Month 1 | 8.33 percent change from baseline | Standard Deviation 43.27 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity | Month 2 | 12.18 percent change from baseline | Standard Deviation 46.8 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity | Month 3 | 6.41 percent change from baseline | Standard Deviation 46.92 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity | Month 4 | 0.00 percent change from baseline | Standard Deviation 25.54 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity | Month 5 | 6.25 percent change from baseline | Standard Deviation 49.59 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity | Month 6 | -2.00 percent change from baseline | Standard Deviation 26.93 |
| Placebo Arm | Changes in Limitations When Completing High-Intensity Activity | Month 5 | -13.04 percent change from baseline | Standard Deviation 23 |
| Placebo Arm | Changes in Limitations When Completing High-Intensity Activity | Month 1 | 3.85 percent change from baseline | Standard Deviation 67.22 |
| Placebo Arm | Changes in Limitations When Completing High-Intensity Activity | Month 4 | -7.64 percent change from baseline | Standard Deviation 50.12 |
| Placebo Arm | Changes in Limitations When Completing High-Intensity Activity | Month 2 | 0.00 percent change from baseline | Standard Deviation 29.27 |
| Placebo Arm | Changes in Limitations When Completing High-Intensity Activity | Month 6 | 0.00 percent change from baseline | Standard Deviation 72.65 |
| Placebo Arm | Changes in Limitations When Completing High-Intensity Activity | Month 3 | -13.77 percent change from baseline | Standard Deviation 21.7 |
p-value: 0.999851t-test, 2 sided
p-value: 0.999524t-test, 2 sided
p-value: 0.576782t-test, 2 sided
p-value: 0.772865t-test, 2 sided
p-value: 0.91384t-test, 2 sided
p-value: 0.992841t-test, 2 sided
Secondary
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Baseline | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.17 score on a scale | Standard Deviation 0.38 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.21 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.17 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.13 score on a scale | Standard Deviation 0.45 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.04 score on a scale | Standard Deviation 0.2 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Baseline | 1.38 score on a scale | Standard Deviation 0.67 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.24 score on a scale | Standard Deviation 0.54 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.24 score on a scale | Standard Deviation 0.54 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.19 score on a scale | Standard Deviation 0.68 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Completing Moderate-Intensity Activity
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 1 | 0.64 percent change from baseline | Standard Deviation 41.76 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 2 | 0.64 percent change from baseline | Standard Deviation 41.76 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 3 | -3.21 percent change from baseline | Standard Deviation 36.52 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 4 | -10.42 percent change from baseline | Standard Deviation 20.74 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 5 | -2.08 percent change from baseline | Standard Deviation 47.73 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 6 | -10.00 percent change from baseline | Standard Deviation 20.41 |
| Placebo Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 5 | -7.97 percent change from baseline | Standard Deviation 18.03 |
| Placebo Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 1 | 8.33 percent change from baseline | Standard Deviation 65.36 |
| Placebo Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 4 | -11.11 percent change from baseline | Standard Deviation 20.06 |
| Placebo Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 2 | 4.67 percent change from baseline | Standard Deviation 49.19 |
| Placebo Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 6 | -1.59 percent change from baseline | Standard Deviation 50.53 |
| Placebo Arm | Changes in Limitations When Completing Moderate-Intensity Activity | Month 3 | -9.42 percent change from baseline | Standard Deviation 18.69 |
p-value: 0.999732t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.999801t-test, 2 sided
p-value: >0.999999t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: >0.999999t-test, 2 sided
Secondary
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Baseline | 1.21 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Baseline | 1.29 score on a scale | Standard Deviation 0.56 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.24 score on a scale | Standard Deviation 0.54 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.19 score on a scale | Standard Deviation 0.51 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.05 score on a scale | Standard Deviation 0.22 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.14 score on a scale | Standard Deviation 0.48 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Moving Around
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Moving Around | Month 1 | 7.69 percent change from baseline | Standard Deviation 27.17 |
| Intervention Arm | Changes in Limitations When Moving Around | Month 2 | 7.69 percent change from baseline | Standard Deviation 27.17 |
| Intervention Arm | Changes in Limitations When Moving Around | Month 3 | 3.85 percent change from baseline | Standard Deviation 19.61 |
| Intervention Arm | Changes in Limitations When Moving Around | Month 4 | 0.00 percent change from baseline | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations When Moving Around | Month 5 | 8.33 percent change from baseline | Standard Deviation 40.82 |
| Intervention Arm | Changes in Limitations When Moving Around | Month 6 | 0.00 percent change from baseline | Standard Deviation 0 |
| Placebo Arm | Changes in Limitations When Moving Around | Month 5 | 2.90 percent change from baseline | Standard Deviation 22.28 |
| Placebo Arm | Changes in Limitations When Moving Around | Month 1 | 14.10 percent change from baseline | Standard Deviation 61.95 |
| Placebo Arm | Changes in Limitations When Moving Around | Month 4 | 5.56 percent change from baseline | Standard Deviation 42.47 |
| Placebo Arm | Changes in Limitations When Moving Around | Month 2 | 6.67 percent change from baseline | Standard Deviation 40.82 |
| Placebo Arm | Changes in Limitations When Moving Around | Month 6 | 12.70 percent change from baseline | Standard Deviation 48.85 |
| Placebo Arm | Changes in Limitations When Moving Around | Month 3 | -1.45 percent change from baseline | Standard Deviation 6.95 |
p-value: 0.999851t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.998326t-test, 2 sided
p-value: 0.998665t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: 0.998846t-test, 2 sided
Secondary
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Baseline | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.04 score on a scale | Standard Deviation 0.2 |
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.00 score on a scale | Standard Deviation 0 |
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Baseline | 1.10 score on a scale | Standard Deviation 0.44 |
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.10 score on a scale | Standard Deviation 0.44 |
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.10 score on a scale | Standard Deviation 0.44 |
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.14 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.19 score on a scale | Standard Deviation 0.51 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 1 | -0.96 percent change from baseline | Standard Deviation 26.91 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 2 | 2.88 percent change from baseline | Standard Deviation 33.41 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 3 | -2.88 percent change from baseline | Standard Deviation 28.57 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 4 | -3.13 percent change from baseline | Standard Deviation 29.77 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 5 | 1.04 percent change from baseline | Standard Deviation 46.9 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 6 | -7.00 percent change from baseline | Standard Deviation 19.79 |
| Placebo Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 5 | -4.35 percent change from baseline | Standard Deviation 14.41 |
| Placebo Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 3 | -1.45 percent change from baseline | Standard Deviation 27.02 |
| Placebo Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 1 | 6.41 percent change from baseline | Standard Deviation 46.92 |
| Placebo Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 4 | -1.39 percent change from baseline | Standard Deviation 26.43 |
| Placebo Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 2 | -1.33 percent change from baseline | Standard Deviation 25.87 |
| Placebo Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs | Month 6 | 14.29 percent change from baseline | Standard Deviation 63.53 |
p-value: 0.999387t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: >0.999999t-test, 2 sided
p-value: 0.999984t-test, 2 sided
p-value: 0.999816t-test, 2 sided
p-value: 0.998367t-test, 2 sided
Secondary
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Baseline | 1.21 score on a scale | Standard Deviation 0.66 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Month 1 | 1.08 score on a scale | Standard Deviation 0.28 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Month 2 | 1.13 score on a scale | Standard Deviation 0.34 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Month 3 | 1.04 score on a scale | Standard Deviation 0.2 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Month 4 | 1.04 score on a scale | Standard Deviation 0.2 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Month 5 | 1.08 score on a scale | Standard Deviation 0.41 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis) | Month 6 | 1.00 score on a scale | Standard Deviation 0 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = Never, 5 = Always). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Baseline | 1.14 score on a scale | Standard Deviation 0.36 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Month 1 | 1.14 score on a scale | Standard Deviation 0.36 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Month 2 | 1.05 score on a scale | Standard Deviation 0.22 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Month 3 | 1.05 score on a scale | Standard Deviation 0.22 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Month 4 | 1.10 score on a scale | Standard Deviation 0.3 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Month 5 | 1.05 score on a scale | Standard Deviation 0.22 |
| Intervention Arm | Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis) | Month 6 | 1.24 score on a scale | Standard Deviation 0.62 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Overall Health as Reported by Parents
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Overall Health as Reported by Parents | Month 1 | 0.45 percent change from baseline | Standard Deviation 15.09 |
| Intervention Arm | Changes in Overall Health as Reported by Parents | Month 2 | 1.22 percent change from baseline | Standard Deviation 13.87 |
| Intervention Arm | Changes in Overall Health as Reported by Parents | Month 3 | -0.51 percent change from baseline | Standard Deviation 15.32 |
| Intervention Arm | Changes in Overall Health as Reported by Parents | Month 4 | 3.75 percent change from baseline | Standard Deviation 15.39 |
| Intervention Arm | Changes in Overall Health as Reported by Parents | Month 5 | 1.32 percent change from baseline | Standard Deviation 15.12 |
| Intervention Arm | Changes in Overall Health as Reported by Parents | Month 6 | 3.27 percent change from baseline | Standard Deviation 14.48 |
| Placebo Arm | Changes in Overall Health as Reported by Parents | Month 5 | 17.17 percent change from baseline | Standard Deviation 40.45 |
| Placebo Arm | Changes in Overall Health as Reported by Parents | Month 1 | 0.19 percent change from baseline | Standard Deviation 31.04 |
| Placebo Arm | Changes in Overall Health as Reported by Parents | Month 4 | 9.17 percent change from baseline | Standard Deviation 27.69 |
| Placebo Arm | Changes in Overall Health as Reported by Parents | Month 2 | 6.73 percent change from baseline | Standard Deviation 34.7 |
| Placebo Arm | Changes in Overall Health as Reported by Parents | Month 6 | 12.46 percent change from baseline | Standard Deviation 31.13 |
| Placebo Arm | Changes in Overall Health as Reported by Parents | Month 3 | 14.42 percent change from baseline | Standard Deviation 28.39 |
p-value: 0.999216t-test, 2 sided
p-value: 0.999779t-test, 2 sided
p-value: 0.559556t-test, 2 sided
p-value: 0.999984t-test, 2 sided
p-value: 0.952545t-test, 2 sided
p-value: 0.998367t-test, 2 sided
Secondary
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Baseline | 4.33 score on a scale | Standard Deviation 0.7 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 1 | 4.29 score on a scale | Standard Deviation 0.62 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 2 | 4.33 score on a scale | Standard Deviation 0.64 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 3 | 4.25 score on a scale | Standard Deviation 0.68 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 4 | 4.42 score on a scale | Standard Deviation 0.5 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 5 | 4.33 score on a scale | Standard Deviation 0.64 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis) | Month 6 | 4.38 score on a scale | Standard Deviation 0.58 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Baseline | 4.05 score on a scale | Standard Deviation 0.8 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 1 | 4.19 score on a scale | Standard Deviation 0.87 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 2 | 4.14 score on a scale | Standard Deviation 0.73 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 3 | 4.43 score on a scale | Standard Deviation 0.68 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 4 | 4.19 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 5 | 4.38 score on a scale | Standard Deviation 0.59 |
| Intervention Arm | Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis) | Month 6 | 4.38 score on a scale | Standard Deviation 0.74 |
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
p-value: >0.9999t-test, 2 sided
Secondary
Changes in Weight
Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups.
Time frame: Baseline, Month 2, Month 4, and Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Weight | Month 2 | 4.67 percent change from baseline | Standard Deviation 7.83 |
| Intervention Arm | Changes in Weight | Month 4 | 5.52 percent change from baseline | Standard Deviation 5.72 |
| Intervention Arm | Changes in Weight | Month 6 | 7.53 percent change from baseline | Standard Deviation 11.69 |
| Placebo Arm | Changes in Weight | Month 6 | 4.65 percent change from baseline | Standard Deviation 5.71 |
| Placebo Arm | Changes in Weight | Month 2 | 4.50 percent change from baseline | Standard Deviation 14.92 |
| Placebo Arm | Changes in Weight | Month 4 | 2.29 percent change from baseline | Standard Deviation 6.8 |
p-value: 0.483382t-test, 2 sided
p-value: 0.483382t-test, 2 sided
p-value: 0.726742t-test, 2 sided
Secondary
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Weight measurement will be taken using a FitBit Smart Scale.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Weight - Nubest Group Only (Within-Group Analysis) | Baseline | 121.68 Pounds | Standard Deviation 40.91 |
| Intervention Arm | Changes in Weight - Nubest Group Only (Within-Group Analysis) | Month 2 | 126.38 Pounds | Standard Deviation 47.81 |
| Intervention Arm | Changes in Weight - Nubest Group Only (Within-Group Analysis) | Month 4 | 124.36 Pounds | Standard Deviation 45.35 |
| Intervention Arm | Changes in Weight - Nubest Group Only (Within-Group Analysis) | Month 6 | 123.82 Pounds | Standard Deviation 34.7 |
p-value: 0.0219t-test, 2 sided
p-value: 0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
Secondary
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Weight measurement will be taken using a FitBit Smart Scale.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in Weight - Placebo Group Only (Within-Group Analysis) | Baseline | 130.43 Pounds | Standard Deviation 50.58 |
| Intervention Arm | Changes in Weight - Placebo Group Only (Within-Group Analysis) | Month 2 | 137.92 Pounds | Standard Deviation 57.12 |
| Intervention Arm | Changes in Weight - Placebo Group Only (Within-Group Analysis) | Month 4 | 133.06 Pounds | Standard Deviation 48.91 |
| Intervention Arm | Changes in Weight - Placebo Group Only (Within-Group Analysis) | Month 6 | 128.99 Pounds | Standard Deviation 46.47 |
p-value: 0.0695t-test, 2 sided
p-value: 0.0124t-test, 2 sided
p-value: 0.0016t-test, 2 sided
Secondary
Increase in Height
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Time frame: Baseline, Month 2, Month 4, and Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Increase in Height | Month 4 | 3.25 percent change from baseline | Standard Deviation 4.19 |
| Intervention Arm | Increase in Height | Month 6 | 3.47 percent change from baseline | Standard Deviation 5.68 |
| Intervention Arm | Increase in Height | Month 2 | 0.89 percent change from baseline | Standard Deviation 4.01 |
| Placebo Arm | Increase in Height | Month 2 | 1.16 percent change from baseline | Standard Deviation 6.29 |
| Placebo Arm | Increase in Height | Month 4 | 1.67 percent change from baseline | Standard Deviation 4.47 |
| Placebo Arm | Increase in Height | Month 6 | 3.49 percent change from baseline | Standard Deviation 4.54 |
p-value: 0.954882t-test, 2 sided
p-value: 0.246176t-test, 2 sided
p-value: 0.954882t-test, 2 sided
Secondary
Increase in Height - Nubest Group Only (Within-Group Analysis)
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Increase in Height - Nubest Group Only (Within-Group Analysis) | Baseline | 61.69 inches | Standard Deviation 5.5 |
| Intervention Arm | Increase in Height - Nubest Group Only (Within-Group Analysis) | Month 2 | 62.01 inches | Standard Deviation 5.82 |
| Intervention Arm | Increase in Height - Nubest Group Only (Within-Group Analysis) | Month 4 | 63.33 inches | Standard Deviation 5.81 |
| Intervention Arm | Increase in Height - Nubest Group Only (Within-Group Analysis) | Month 6 | 63.24 inches | Standard Deviation 4.54 |
p-value: 0.7419t-test, 2 sided
p-value: 0.0033t-test, 2 sided
p-value: 0.0219t-test, 2 sided
Secondary
Increase in Height - Placebo Group Only (Within-Group Analysis)
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Time frame: Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Increase in Height - Placebo Group Only (Within-Group Analysis) | Baseline | 60.66 inches | Standard Deviation 7.07 |
| Intervention Arm | Increase in Height - Placebo Group Only (Within-Group Analysis) | Month 2 | 62.41 inches | Standard Deviation 5.88 |
| Intervention Arm | Increase in Height - Placebo Group Only (Within-Group Analysis) | Month 4 | 62.71 inches | Standard Deviation 5.29 |
| Intervention Arm | Increase in Height - Placebo Group Only (Within-Group Analysis) | Month 6 | 63.05 inches | Standard Deviation 5.24 |
p-value: 0.7708t-test, 2 sided
p-value: 0.239t-test, 2 sided
p-value: 0.006t-test, 2 sided
Secondary
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Much worse, 5 = Much Better). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Population: The number of participants analyzed at each time point reflects the available data from participants who completed assessments at that specific time point. The decreasing numbers are due to participant dropouts and missed measurements. All data were analyzed using an intention-to-treat (ITT) approach, with results reported for all participants who provided data at each respective time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 1 | 12.82 percent change from baseline | Standard Deviation 23.24 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 2 | 18.27 percent change from baseline | Standard Deviation 26.46 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 3 | 20.19 percent change from baseline | Standard Deviation 26.68 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 4 | 19.44 percent change from baseline | Standard Deviation 23.91 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 5 | 12.85 percent change from baseline | Standard Deviation 23.05 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 6 | 24.00 percent change from baseline | Standard Deviation 29 |
| Placebo Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 5 | 28.99 percent change from baseline | Standard Deviation 30.96 |
| Placebo Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 1 | 8.01 percent change from baseline | Standard Deviation 36.25 |
| Placebo Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 4 | 25.90 percent change from baseline | Standard Deviation 42.88 |
| Placebo Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 2 | 17.33 percent change from baseline | Standard Deviation 38.56 |
| Placebo Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 6 | 24.21 percent change from baseline | Standard Deviation 25.4 |
| Placebo Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago. | Month 3 | 25.00 percent change from baseline | Standard Deviation 27.75 |
p-value: 0.999851t-test, 2 sided
p-value: 0.999838t-test, 2 sided
p-value: 0.991697t-test, 2 sided
p-value: 0.999984t-test, 2 sided
p-value: 0.581904t-test, 2 sided
p-value: 0.999866t-test, 2 sided
Secondary
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Baseline | 3.17 score on a scale | Standard Deviation 0.48 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Month 1 | 3.58 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Month 2 | 3.63 score on a scale | Standard Deviation 0.77 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Month 3 | 3.71 score on a scale | Standard Deviation 0.86 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Month 4 | 3.75 score on a scale | Standard Deviation 0.74 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Month 5 | 3.54 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis) | Month 6 | 3.83 score on a scale | Standard Deviation 0.87 |
p-value: 0.4598t-test, 2 sided
p-value: 0.23t-test, 2 sided
p-value: 0.0806t-test, 2 sided
p-value: 0.0969t-test, 2 sided
p-value: 0.6098t-test, 2 sided
p-value: 0.0369t-test, 2 sided
Secondary
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = Very Poor , 5 = Excellent). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Population: Within-group analysis. No between-group comparison reported for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Baseline | 3.29 score on a scale | Standard Deviation 0.72 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Month 1 | 3.52 score on a scale | Standard Deviation 0.75 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Month 2 | 3.57 score on a scale | Standard Deviation 1.08 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Month 3 | 3.90 score on a scale | Standard Deviation 0.89 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Month 4 | 3.71 score on a scale | Standard Deviation 0.9 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Month 5 | 4.05 score on a scale | Standard Deviation 0.92 |
| Intervention Arm | Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis) | Month 6 | 4.05 score on a scale | Standard Deviation 0.97 |
p-value: >0.9999t-test, 2 sided
p-value: 0.982t-test, 2 sided
p-value: 0.091t-test, 2 sided
p-value: 0.4449t-test, 2 sided
p-value: 0.0204t-test, 2 sided
p-value: 0.0256t-test, 2 sided