Pediatric Obesity
Conditions
Keywords
Latino, Rural Communities, Mindfulness
Brief summary
The purpose of this study is to refine and optimize an obesity intervention with rural underserved Latino children and their parents that combines a standard family-based behavioral approach, the gold standard for pediatric obesity treatment, with a mindfulness approach focusing on stress reduction (now ADAPT+).
Detailed description
Latino youth have the highest prevalence of obesity as compared to Black or White youth, and are at high risk for adult obesity-related complications including cardiovascular disease. Moreover, Latino youth living in rural communities have an increased risk of adult obesity and mortality due to obesity-related chronic disease than Latinos living elsewhere. The investigators synthesized the prior childhood obesity intervention and tailored the evidence informed, theory-based, multi-family behavioral intervention, Adapting Diet and Action for Everyone (ADAPT), to the acculturation status, language, and national origin of the target population - obese, school-aged (8-12 years old) Latino youth and their parents living in rural areas. However, because the role of parent stress on obesity has not been adequately addressed in interventions aimed at reducing obesity in Latino youth, it is argued that mindfulness parent stress reduction strategies may be a key component to improving eating and physical activity (PA) behaviors in both children and their parents. This study proposes a refinement and optimization of the original ADAPT obesity intervention protocol to include mindfulness parent stress reduction strategies (now ADAPT+) and feasibility assessment of ADAPT+ implementation. Aim 1: Refinement of ADAPT+ (ADAPT + mindfulness parent stress reduction). Aim 1A and Aim 1B were focus groups with promotoras from the target communities and parents. The intervention manual was refined based on the qualitative feedback. Aim 1C further refines the manual via a small one parent-child cohort. Data collected at Aim 1C was used to finalize and optimize a culturally acceptable ADAPT+ evaluated in Aim 2. Aim 2: Feasibility and Acceptability trial. A randomized trial testing feasibility of ADAPT+ vs. Enhanced Usual Care (EUC) conducted in two rural communities. It is anticipated that compared to EUC, ADAPT+ dyads will have a lower attrition rate and will report greater satisfaction. The investigators also explore whether the eating and stress indices are sensitive to the intervention.
Interventions
BEHAVIORALEUC
Enhanced Usual Care is an abbreviated version of the full ADAPT+ intervention in which parents are engaged in a one-time, two hour information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.
BEHAVIORALADAPT+
ADAPT+ is designed as an 6-week intervention. For each session, children and parents participate in separate 1.5-hour group meetings, followed by a joint goal setting session. Practical strategies related to improving diet and physical activity as well as the role of dealing with parent stress-related factors related to making long-lasting behavioral changes in the family are addressed.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment. Aim 2 was the small pilot RCT
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Child with a BMI %ile of 85 or higher. * The target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4th grade reading level (able to follow basic instructions in Spanish), and able to perform simple physical exercises.
Exclusion criteria
* A child who has a medical/developmental condition that precludes weight loss using conventional diet and PA methods. * A child has been on antibiotics or steroids in the previous three months. * The parent is ineligible if he/she is non-ambulatory, is pregnant, or has a medical condition that may be negatively impacted by PA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 6 weeks after baseline | Acceptability was measured by a program satisfaction survey at the end of the intervention. Items were rated on a scale from 1 (Not at all) to 4 (Very) enjoyable, comfortable, receptive, relevant, or helpful, depending on the item's content. A mean score was calculated using all items to reflect overall satisfaction, with higher scores indicating greater satisfaction. Only parents completed the program satisfaction survey. Minimum score: 1 Maximum score: 4 Higher scores mean better outcomes. |
| Feasibility - Accrual Rates | 6 weeks after baseline | Percent of families approached who agreed to participate. This was done at the parent/dyad level. |
| Feasibility - Number of Participants Attending 75%+ Sessions | 6 weeks after baseline | Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level. |
| Retention Over Time (From Baseline to Post-assessment) | From baseline to post-assessment (6-weeks) | Percentage of families retained for post-intervention assessment |
| Retention Over Time (From Baseline to 3-month Follow-up) | From baseline to 3-month follow-up | Percentage of families retained for 3-month follow-up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the USDA Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported. Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently. Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed. Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently. Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed. Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently. Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed. |
| Parent BMI (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score. |
| Parent BMI (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score. |
| Parent Waist-to-Hip Ratio (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio. |
| Parent Waist-to-Hip Ratio (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio. |
| Child BMI z Score (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff. Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI. |
| Latino Dietary Behaviors Questionnaire (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors. |
| Perceived Stress Scale (PSS) [Post-Assessment] | Post-Assessment (6 weeks after Baseline) | Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress. |
| Perceived Stress Scale (PSS) [3-month Follow-up] | 3-month Follow-up (3 months after Post-Assessment) | Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress. |
| Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues. |
| Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues. |
| Latino Dietary Behaviors Questionnaire (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors. |
| Child BMI z Score (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff. Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI. |
| Child Waist-to-Hip Ratio (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio. |
| Child Waist-to-Hip Ratio (3-month Follow-up) | 3-month Follow-up (3 months after Post-Assessment) | Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio. |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Post-Assessment (6 weeks after Baseline) | The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported. Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently. Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed. Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently. Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed. Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently. Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed. |
Countries
United States
Participant flow
Pre-assignment details
A total of 48 parent/child dyad pairs were considered enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Feasibility and Acceptability of ADAPT+ ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population.
ADAPT+: ADAPT+ is designed as an 8-week intervention. For each session, children and parents participate in separate 1.5-hour group meetings, followed by a joint goal setting session. Practical strategies related to improving diet and physical activity as well as the role of dealing with parent stress-related factors related to making long-lasting behavioral changes in the family are addressed. | 47 |
| Enhanced Usual Care (EUC) Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session.
EUC: Enhanced Usual Care is an abbreviated version of the full ADAPT+ intervention in which parents are engaged in a one-time, two hour information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves. | 48 |
| Total | 95 |
Baseline characteristics
| Characteristic | Enhanced Usual Care (EUC) | Total | Feasibility and Acceptability of ADAPT+ |
|---|---|---|---|
| Age, Continuous Parents | 38.56 years STANDARD_DEVIATION 6.92 | 38.98 years STANDARD_DEVIATION 7.01 | 39.60 years STANDARD_DEVIATION 7.19 |
| Age, Continuous Youth | 10.36 years STANDARD_DEVIATION 1.45 | 9.99 years STANDARD_DEVIATION 1.53 | 9.61 years STANDARD_DEVIATION 1.55 |
| BMI (parent) | 31.18 kg/m^2 STANDARD_DEVIATION 5.68 | 31.43 kg/m^2 STANDARD_DEVIATION 5.25 | 31.68 kg/m^2 STANDARD_DEVIATION 4.88 |
| BMI z-score (child) | 1.69 Z-score STANDARD_DEVIATION 1.05 | 1.96 Z-score STANDARD_DEVIATION 1.01 | 2.25 Z-score STANDARD_DEVIATION 0.91 |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) Fast Food: Frequency | .78 units on a scale STANDARD_DEVIATION 0.54 | .88 units on a scale STANDARD_DEVIATION 0.65 | 1.00 units on a scale STANDARD_DEVIATION 0.76 |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) Fast Food: Quantity | 3.17 units on a scale STANDARD_DEVIATION 2.68 | 3.47 units on a scale STANDARD_DEVIATION 2.4 | 3.81 units on a scale STANDARD_DEVIATION 2.07 |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) Fruit & Vegetable: Frequency | 6.44 units on a scale STANDARD_DEVIATION 3.63 | 6.85 units on a scale STANDARD_DEVIATION 3.4 | 7.31 units on a scale STANDARD_DEVIATION 3.18 |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) Fruit & Vegetable: Quantity | 3.25 units on a scale STANDARD_DEVIATION 0.79 | 3.29 units on a scale STANDARD_DEVIATION 0.75 | 3.34 units on a scale STANDARD_DEVIATION 0.72 |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) Sugar-Sweetened Beverage: Frequency | 2.39 units on a scale STANDARD_DEVIATION 1.61 | 2.38 units on a scale STANDARD_DEVIATION 1.86 | 2.37 units on a scale STANDARD_DEVIATION 2.16 |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) Sugar-Sweetened Beverage: Quantity | 1.96 units on a scale STANDARD_DEVIATION 0.8 | 2.00 units on a scale STANDARD_DEVIATION 1.03 | 2.06 units on a scale STANDARD_DEVIATION 1.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 95 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Latino Dietary Behaviors Questionnaire (parent) | 24.83 units on a scale STANDARD_DEVIATION 4 | 24.90 units on a scale STANDARD_DEVIATION 4.29 | 24.96 units on a scale STANDARD_DEVIATION 4.65 |
| Perceived Stress Scale (PSS) (parent) | 16.04 units on a scale STANDARD_DEVIATION 6.79 | 17.08 units on a scale STANDARD_DEVIATION 6.32 | 18.13 units on a scale STANDARD_DEVIATION 5.78 |
| Race/Ethnicity, Customized Parents Black | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Parents More than one race | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Parents Other race | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Parents Unknown | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Parents White | 14 Participants | 30 Participants | 16 Participants |
| Race/Ethnicity, Customized Youth Black | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Youth More than one race | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Youth Other race | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Youth Unknown | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Youth White | 13 Participants | 29 Participants | 16 Participants |
| Recognize subscale of the Mindful Eating Questionnaire (parent) | 29.83 units on a scale STANDARD_DEVIATION 3.67 | 29.81 units on a scale STANDARD_DEVIATION 3.98 | 29.79 units on a scale STANDARD_DEVIATION 4.35 |
| Region of Enrollment United States | 48 participants | 95 participants | 47 participants |
| Resting blood pressure (child) Diastolic Blood Pressure | 57.92 millimeters of mercury (mmHg) STANDARD_DEVIATION 9.23 | 59.43 millimeters of mercury (mmHg) STANDARD_DEVIATION 8.12 | 61.00 millimeters of mercury (mmHg) STANDARD_DEVIATION 6.61 |
| Resting blood pressure (child) Systolic Blood Pressure | 105.67 millimeters of mercury (mmHg) STANDARD_DEVIATION 10.6 | 106.96 millimeters of mercury (mmHg) STANDARD_DEVIATION 10.05 | 108.34 millimeters of mercury (mmHg) STANDARD_DEVIATION 9.5 |
| Resting blood pressure (parent) Diastolic Blood Pressure | 71.21 millimeters of mercury (mmHg) STANDARD_DEVIATION 9.94 | 71.80 millimeters of mercury (mmHg) STANDARD_DEVIATION 9.34 | 72.39 millimeters of mercury (mmHg) STANDARD_DEVIATION 8.87 |
| Resting blood pressure (parent) Systolic Blood Pressure | 117.17 millimeters of mercury (mmHg) STANDARD_DEVIATION 15.45 | 118.28 millimeters of mercury (mmHg) STANDARD_DEVIATION 15.24 | 119.40 millimeters of mercury (mmHg) STANDARD_DEVIATION 15.27 |
| Sex: Female, Male Parents Female | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Parents Male | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Youth Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Youth Male | 11 Participants | 23 Participants | 12 Participants |
| Stephenson Multigroup Acculturation Scale [SMAS] (parent) | 2.99 units on a scale STANDARD_DEVIATION 0.37 | 2.99 units on a scale STANDARD_DEVIATION 0.36 | 3.00 units on a scale STANDARD_DEVIATION 0.36 |
| Waist-to-hip ratio (WHR) (child) | .90 Waist-to-hip ratio STANDARD_DEVIATION 0.08 | .91 Waist-to-hip ratio STANDARD_DEVIATION 0.07 | .92 Waist-to-hip ratio STANDARD_DEVIATION 0.06 |
| Waist-to-hip ratio (WHR) (parent) | .90 Waist-to-hip ratio STANDARD_DEVIATION 0.07 | .90 Waist-to-hip ratio STANDARD_DEVIATION 0.06 | .90 Waist-to-hip ratio STANDARD_DEVIATION 0.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 48 |
| other Total, other adverse events | 0 / 47 | 0 / 48 |
| serious Total, serious adverse events | 0 / 47 | 0 / 48 |
Outcome results
Primary
Acceptability
Acceptability was measured by a program satisfaction survey at the end of the intervention. Items were rated on a scale from 1 (Not at all) to 4 (Very) enjoyable, comfortable, receptive, relevant, or helpful, depending on the item's content. A mean score was calculated using all items to reflect overall satisfaction, with higher scores indicating greater satisfaction. Only parents completed the program satisfaction survey. Minimum score: 1 Maximum score: 4 Higher scores mean better outcomes.
Time frame: 6 weeks after baseline
Population: This number refers to the parents who completed the exit survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Acceptability | 3.91 score on a scale | Standard Deviation 0.18 |
| Enhanced Usual Care (EUC) | Acceptability | 3.85 score on a scale | Standard Deviation 0.32 |
Primary
Feasibility - Accrual Rates
Percent of families approached who agreed to participate. This was done at the parent/dyad level.
Time frame: 6 weeks after baseline
Population: This number refers to the parent-child dyads.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Feasibility - Accrual Rates | 24 Participants |
| Enhanced Usual Care (EUC) | Feasibility - Accrual Rates | 24 Participants |
Primary
Feasibility - Number of Participants Attending 75%+ Sessions
Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level.
Time frame: 6 weeks after baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Feasibility - Number of Participants Attending 75%+ Sessions | 38 Participants |
| Enhanced Usual Care (EUC) | Feasibility - Number of Participants Attending 75%+ Sessions | 48 Participants |
Primary
Retention Over Time (From Baseline to 3-month Follow-up)
Percentage of families retained for 3-month follow-up assessment
Time frame: From baseline to 3-month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Retention Over Time (From Baseline to 3-month Follow-up) | 41 Participants |
| Enhanced Usual Care (EUC) | Retention Over Time (From Baseline to 3-month Follow-up) | 35 Participants |
Primary
Retention Over Time (From Baseline to Post-assessment)
Percentage of families retained for post-intervention assessment
Time frame: From baseline to post-assessment (6-weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Retention Over Time (From Baseline to Post-assessment) | 44 Participants |
| Enhanced Usual Care (EUC) | Retention Over Time (From Baseline to Post-assessment) | 35 Participants |
Secondary
Child BMI z Score (3-month Follow-up)
Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff. Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Child BMI z Score (3-month Follow-up) | 2.30 Z-score | Standard Deviation 0.83 |
| Enhanced Usual Care (EUC) | Child BMI z Score (3-month Follow-up) | 1.58 Z-score | Standard Deviation 0.89 |
Secondary
Child BMI z Score (Post-Assessment)
Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff. Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Child BMI z Score (Post-Assessment) | 2.28 Z-score | Standard Deviation 0.98 |
| Enhanced Usual Care (EUC) | Child BMI z Score (Post-Assessment) | 1.48 Z-score | Standard Deviation 1.02 |
Secondary
Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up)
The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the USDA Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported. Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently. Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed. Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently. Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed. Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently. Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fruit & Vegetable: Frequency | 5.84 score on a scale | Standard Deviation 2.59 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fruit & Vegetable: Quantity | 2.95 score on a scale | Standard Deviation 0.96 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Sugar-Sweetened Beverage: Frequency | 1.63 score on a scale | Standard Deviation 1.07 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Sugar-Sweetened Beverage: Quantity | 1.53 score on a scale | Standard Deviation 0.87 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fast Food: Frequency | .74 score on a scale | Standard Deviation 0.56 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fast Food: Quantity | 3.26 score on a scale | Standard Deviation 3.07 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fast Food: Frequency | .75 score on a scale | Standard Deviation 0.86 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fruit & Vegetable: Frequency | 6.88 score on a scale | Standard Deviation 3.01 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Sugar-Sweetened Beverage: Quantity | 1.47 score on a scale | Standard Deviation 1.01 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fruit & Vegetable: Quantity | 3.25 score on a scale | Standard Deviation 0.61 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Fast Food: Quantity | 3.00 score on a scale | Standard Deviation 2.63 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | Sugar-Sweetened Beverage: Frequency | 1.75 score on a scale | Standard Deviation 1.34 |
Secondary
Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)
The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported. Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently. Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed. Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently. Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed. Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently. Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fruit & Vegetable: Frequency | 7.18 score on a scale | Standard Deviation 3.38 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fruit & Vegetable: Quantity | 3.09 score on a scale | Standard Deviation 0.7 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Sugar-Sweetened Beverage: Frequency | 2.23 score on a scale | Standard Deviation 1.95 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Sugar-Sweetened Beverage: Quantity | 2.17 score on a scale | Standard Deviation 1.3 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fast Food: Frequency | .91 score on a scale | Standard Deviation 0.92 |
| Feasibility and Acceptability of ADAPT+ | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fast Food: Quantity | 3.38 score on a scale | Standard Deviation 2.96 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fast Food: Frequency | .35 score on a scale | Standard Deviation 0.49 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fruit & Vegetable: Frequency | 6.53 score on a scale | Standard Deviation 2.35 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Sugar-Sweetened Beverage: Quantity | 1.91 score on a scale | Standard Deviation 1.18 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fruit & Vegetable: Quantity | 3.15 score on a scale | Standard Deviation 0.61 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Fast Food: Quantity | 1.53 score on a scale | Standard Deviation 2.27 |
| Enhanced Usual Care (EUC) | Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment) | Sugar-Sweetened Beverage: Frequency | 1.71 score on a scale | Standard Deviation 1.36 |
Secondary
Child Waist-to-Hip Ratio (3-month Follow-up)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Child Waist-to-Hip Ratio (3-month Follow-up) | .94 Waist-to-Hip Ratio | Standard Deviation 0.09 |
| Enhanced Usual Care (EUC) | Child Waist-to-Hip Ratio (3-month Follow-up) | .90 Waist-to-Hip Ratio | Standard Deviation 0.08 |
Secondary
Child Waist-to-Hip Ratio (Post-Assessment)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Child Waist-to-Hip Ratio (Post-Assessment) | .92 Waist-to-Hip Ratio | Standard Deviation 0.05 |
| Enhanced Usual Care (EUC) | Child Waist-to-Hip Ratio (Post-Assessment) | .92 Waist-to-Hip Ratio | Standard Deviation 0.07 |
Secondary
Latino Dietary Behaviors Questionnaire (3-month Follow-up)
The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Latino Dietary Behaviors Questionnaire (3-month Follow-up) | 26.59 score on a scale | Standard Deviation 3.5 |
| Enhanced Usual Care (EUC) | Latino Dietary Behaviors Questionnaire (3-month Follow-up) | 24.50 score on a scale | Standard Deviation 3.43 |
Secondary
Latino Dietary Behaviors Questionnaire (Post-Assessment)
The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Latino Dietary Behaviors Questionnaire (Post-Assessment) | 27.41 score on a scale | Standard Deviation 4.58 |
| Enhanced Usual Care (EUC) | Latino Dietary Behaviors Questionnaire (Post-Assessment) | 26.00 score on a scale | Standard Deviation 4.21 |
Secondary
Parent BMI (3-month Follow-up)
Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Parent BMI (3-month Follow-up) | 31.06 kg/m2 | Standard Deviation 4.47 |
| Enhanced Usual Care (EUC) | Parent BMI (3-month Follow-up) | 31.41 kg/m2 | Standard Deviation 5.27 |
Secondary
Parent BMI (Post-Assessment)
Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Parent BMI (Post-Assessment) | 31.29 kg/m^2 | Standard Deviation 4.59 |
| Enhanced Usual Care (EUC) | Parent BMI (Post-Assessment) | 30.86 kg/m^2 | Standard Deviation 6.14 |
Secondary
Parent Waist-to-Hip Ratio (3-month Follow-up)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Parent Waist-to-Hip Ratio (3-month Follow-up) | .88 Waist-to-Hip Ratio | Standard Deviation 0.08 |
| Enhanced Usual Care (EUC) | Parent Waist-to-Hip Ratio (3-month Follow-up) | .88 Waist-to-Hip Ratio | Standard Deviation 0.07 |
Secondary
Parent Waist-to-Hip Ratio (Post-Assessment)
Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Parent Waist-to-Hip Ratio (Post-Assessment) | .87 Waist-to-Hip Ratio | Standard Deviation 0.04 |
| Enhanced Usual Care (EUC) | Parent Waist-to-Hip Ratio (Post-Assessment) | .88 Waist-to-Hip Ratio | Standard Deviation 0.08 |
Secondary
Perceived Stress Scale (PSS) [3-month Follow-up]
Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Perceived Stress Scale (PSS) [3-month Follow-up] | 15.36 score on a scale | Standard Deviation 5.39 |
| Enhanced Usual Care (EUC) | Perceived Stress Scale (PSS) [3-month Follow-up] | 18.44 score on a scale | Standard Deviation 2.5 |
Secondary
Perceived Stress Scale (PSS) [Post-Assessment]
Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Perceived Stress Scale (PSS) [Post-Assessment] | 16.27 score on a scale | Standard Deviation 4.87 |
| Enhanced Usual Care (EUC) | Perceived Stress Scale (PSS) [Post-Assessment] | 15.33 score on a scale | Standard Deviation 4.91 |
Secondary
Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up)
Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues.
Time frame: 3-month Follow-up (3 months after Post-Assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up) | 31.14 score on a scale | Standard Deviation 4.72 |
| Enhanced Usual Care (EUC) | Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up) | 29.13 score on a scale | Standard Deviation 4.36 |
Secondary
Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment)
Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues.
Time frame: Post-Assessment (6 weeks after Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feasibility and Acceptability of ADAPT+ | Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment) | 30.55 score on a scale | Standard Deviation 2.96 |
| Enhanced Usual Care (EUC) | Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment) | 29.72 score on a scale | Standard Deviation 2.74 |