Nutrition Disorders, Obesity, Overnutrition, Child, Pediatric Obesity
Conditions
Keywords
Food Insecurity, Nutrition Security
Brief summary
The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.
Detailed description
Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.
Interventions
BEHAVIORALMeal Kit Delivery
Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (\ 2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.
BEHAVIORALNewsletter + Food Pantry Referral
Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dyads (caregiver + child) will be randomized to one of two intervention sequences: 1. Meal kit intervention without delay followed by newsletter + pantry referral 2. Newsletter + pantry referral followed by meal kit intervention
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Child Inclusion Criteria: * Children \>=6 years and \<12 years old with a BMI \>=95th percentile * Children who screen positive on the 2-item Hunger Vital Sign™ * Children living in a household of \<=5 people * Children living with an English and/or Spanish-speaking caregiver * Children living within the EatWell delivery map boundaries in the greater Boston area Child
Exclusion criteria
* History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit * History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease) * History of type 1 or 2 diabetes * History of solid tumor or bone marrow transplant * Enteral tube dependence The child's primary caregiver will be eligible for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Feasibility: Randomization | At baseline | Number of participants enrolled per month, then subject to randomization. |
| Study Feasibility: Assessments | At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) | Proportion of planned assessments completed at each study visit |
| Study Feasibility: Adherence - Children | Third study visit (week 14-16) | Number of children who tasted/ate food from the meal kit |
| Study Feasibility: Adherence - Caregivers | Third study visit (week 14-16) | Total number of recipes prepared by caregivers |
| Study Feasibility: Protocol | Third study visit (week 14-16) | Number of participants who reported receipt of all six weeks of meal kit delivery |
| Study Feasibility: Retention | At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16). | Number of participants retained at each study visit |
| Study Feasibility: Recruitment | 2 months to baseline | Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Household Food Insecurity at Third Study Visit | At third study visit (week 14-16) | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security |
| Number of Participants With Household Food Insecurity at the First Study Visit | At the baseline first study visit (baseline) | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security |
| Number of Participants With Household Food Insecurity at Second Study Visit | At second study visit (week 6-8) | Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security |
| Change in BMI For Children With BMI Assessments At All Visits | At baseline, at second study visit (week 6-8), and at third study visit (week 14-16) | Weight and height were combined to report BMI in kg/m\^2 based on Centers for Disease Control growth curves. |
| Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | At baseline, at second study visit (week 6-8), and at third study visit (week 14-16) | BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Prime Diet Quality Score at Each Study Visit: Caregiver | At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) | The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality. |
| Caregiver Perceived Stress at Third Study Visit | At third study visit (week 14-16) | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress |
| Caregiver Perceived Stress at Second Study Visit | At second study visit (week 6-8) | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress |
| Caregiver Perceived Stress at First Study Visit | At baseline first study visit (baseline) | The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress |
| Caregiver Reported Mealtime Behavior at Third Study Visit | At third study visit (week 14-16) | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): How often does your child eat dinner together with family members? |
| Caregiver Reported Mealtime Behavior at Second Study Visit | At second study visit (week 6-8) | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): How often does your child eat dinner together with family members? |
| Total Prime Diet Quality Score at Each Study Visit: Children | At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16) | The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality. |
| Caregiver Reported Mealtime Behavior at First Study Visit | At baseline first study visit (baseline) | Caregivers rated Likert scale items from 1 (never) to 5 (everyday): How often does your child eat dinner together with family members? |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted at a primary care clinic between February and March 2023. The first participant was enrolled on February 13, 2023, and the last participant was enrolled on March 9, 2023.
Pre-assignment details
Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Meal Kits, Then Newsletter + Food Pantry Referral Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral. | 29 |
| Newsletter + Food Pantry Referral, Then Meal Kits Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Intervention (6 Weeks) | Lost to Follow-up | 4 | 4 | 3 | 3 |
| Second Intervention (6 Weeks) | Lost to Follow-up | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Age, Continuous Caregiver age | 42 years | 39 years | 42 years |
| Age, Continuous Child age | 10 years | 9 years | 9 years |
| Caregiver marital status Divorced | 1 Participants | 3 Participants | 4 Participants |
| Caregiver marital status Married | 3 Participants | 3 Participants | 6 Participants |
| Caregiver marital status Missing | 1 Participants | 0 Participants | 1 Participants |
| Caregiver marital status Never married | 5 Participants | 2 Participants | 7 Participants |
| Caregiver marital status Prefer not to answer | 0 Participants | 3 Participants | 3 Participants |
| Caregiver marital status Separated | 3 Participants | 4 Participants | 7 Participants |
| Caregiver marital status Widowed | 1 Participants | 0 Participants | 1 Participants |
| Caregiver relationship to child Father | 1 Participants | 2 Participants | 3 Participants |
| Caregiver relationship to child Missing | 1 Participants | 0 Participants | 1 Participants |
| Caregiver relationship to child Mother | 12 Participants | 13 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Caregiver ethnicity Hispanic or Latino | 9 Participants | 15 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Caregiver ethnicity Not Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Caregiver ethnicity Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Child ethnicity Hispanic or Latino | 11 Participants | 15 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Child ethnicity Not Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Child ethnicity Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Highest grade or degree completed 8th grade or less | 2 Participants | 2 Participants | 4 Participants |
| Highest grade or degree completed College graduate | 3 Participants | 2 Participants | 5 Participants |
| Highest grade or degree completed Don't know or prefer not to answer | 0 Participants | 0 Participants | 0 Participants |
| Highest grade or degree completed High school graduate | 3 Participants | 4 Participants | 7 Participants |
| Highest grade or degree completed Missing | 1 Participants | 0 Participants | 1 Participants |
| Highest grade or degree completed Postgraduate training or degree | 1 Participants | 0 Participants | 1 Participants |
| Highest grade or degree completed Some college or technical school | 2 Participants | 1 Participants | 3 Participants |
| Highest grade or degree completed Some high school | 2 Participants | 6 Participants | 8 Participants |
| Number of people living in the household Number of adults 18 years and older | 2 persons | 2 persons | 2 persons |
| Number of people living in the household Number of children younger than 18 years | 2 persons | 2 persons | 2 persons |
| Race (NIH/OMB) Caregiver race American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Caregiver race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver race Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Caregiver race More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver race Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver race Unknown or Not Reported | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Caregiver race White | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Child race American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Child race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child race Black or African American | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Child race More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Child race Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Child race Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Child race White | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Caregiver sex Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Caregiver sex Male | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Child sex Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Child sex Male | 10 Participants | 7 Participants | 17 Participants |
| Total annual household income Between $20,000 and $70,000 | 2 Participants | 3 Participants | 5 Participants |
| Total annual household income Don't know | 2 Participants | 1 Participants | 3 Participants |
| Total annual household income Less than $20,000 | 7 Participants | 10 Participants | 17 Participants |
| Total annual household income Missing | 1 Participants | 0 Participants | 1 Participants |
| Total annual household income More than $70,000 | 2 Participants | 0 Participants | 2 Participants |
| Total annual household income Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 26 |
Outcome results
Primary
Study Feasibility: Adherence - Caregivers
Total number of recipes prepared by caregivers
Time frame: Third study visit (week 14-16)
Population: All caregivers with assessment data at the third study visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Study Feasibility: Adherence - Caregivers | Caregivers who prepared 1-2 recipes | 2 Participants |
| Both Arms | Study Feasibility: Adherence - Caregivers | Caregivers who prepared 3-6 recipes | 4 Participants |
| Both Arms | Study Feasibility: Adherence - Caregivers | Caregivers who did not prepare any recipe | 1 Participants |
| Both Arms | Study Feasibility: Adherence - Caregivers | Caregivers who prepared 7-12 recipes | 3 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Adherence - Caregivers | Caregivers who did not prepare any recipe | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Adherence - Caregivers | Caregivers who prepared 3-6 recipes | 4 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Adherence - Caregivers | Caregivers who prepared 1-2 recipes | 5 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Adherence - Caregivers | Caregivers who prepared 7-12 recipes | 2 Participants |
Primary
Study Feasibility: Adherence - Children
Number of children who tasted/ate food from the meal kit
Time frame: Third study visit (week 14-16)
Population: All caregivers with assessment data at the third study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Both Arms | Study Feasibility: Adherence - Children | 10 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Adherence - Children | 11 Participants |
Primary
Study Feasibility: Assessments
Proportion of planned assessments completed at each study visit
Time frame: At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Population: The first study visit included a baseline demographic survey, 2 child assessments, and 1 caregiver assessment. The second study visit included 2 child assessments and 1 parent assessment. The third study visit included 2 child assessments, 1 parent assessment, and 1 satisfaction questionnaire. The Meal Kit Delivery, Then Newsletter + Food Pantry Referral arm included 14 caregivers and 15 children (one pair of siblings), thus the discrepancy between total planned assessments in each arm.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Both Arms | Study Feasibility: Assessments | Planned assessments completed after visit 1 | 56 Survey/Assessments |
| Both Arms | Study Feasibility: Assessments | Planned assessments completed after visit 2 | 32 Survey/Assessments |
| Both Arms | Study Feasibility: Assessments | Planned assessments completed after visit 3 | 38 Survey/Assessments |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Assessments | Planned assessments completed after visit 1 | 60 Survey/Assessments |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Assessments | Planned assessments completed after visit 2 | 35 Survey/Assessments |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Assessments | Planned assessments completed after visit 3 | 43 Survey/Assessments |
Primary
Study Feasibility: Protocol
Number of participants who reported receipt of all six weeks of meal kit delivery
Time frame: Third study visit (week 14-16)
Population: All participants with assessment data at the third study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Both Arms | Study Feasibility: Protocol | 19 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Protocol | 22 Participants |
Primary
Study Feasibility: Randomization
Number of participants enrolled per month, then subject to randomization.
Time frame: At baseline
Population: All participants (caregivers and children) who consented to participate in the study. Randomization occurred by caregiver after completing the consent. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Study Feasibility: Randomization | Number of participants enrolled (February) | 20 Participants |
| Both Arms | Study Feasibility: Randomization | Number of participants enrolled (March) | 9 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Randomization | Number of participants enrolled (February) | 20 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Randomization | Number of participants enrolled (March) | 10 Participants |
Primary
Study Feasibility: Recruitment
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
Time frame: 2 months to baseline
Population: All participants who met eligibility criteria after being screened.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Study Feasibility: Recruitment | Enrolled | 59 Participants |
| Both Arms | Study Feasibility: Recruitment | Declined to enroll | 10 Participants |
Primary
Study Feasibility: Retention
Number of participants retained at each study visit
Time frame: At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).
Population: All participants enrolled in the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Both Arms | Study Feasibility: Retention | Third study visit | Participants remaining in study visit | 10 Participants |
| Both Arms | Study Feasibility: Retention | First study visit | Participants remaining in study visit | 13 Participants |
| Both Arms | Study Feasibility: Retention | Second study visit | Participants remaining in study visit | 10 Participants |
| Both Arms | Study Feasibility: Retention | Third study visit | Participants lost to follow up in study visit | 0 Participants |
| Both Arms | Study Feasibility: Retention | Second study visit | Participants lost to follow up in study visit | 3 Participants |
| Both Arms | Study Feasibility: Retention | First study visit | Participants lost to follow up in study visit | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Retention | Third study visit | Participants remaining in study visit | 11 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Retention | Second study visit | Participants remaining in study visit | 11 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Retention | First study visit | Participants lost to follow up in study visit | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Retention | Third study visit | Participants lost to follow up in study visit | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Retention | First study visit | Participants remaining in study visit | 14 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Study Feasibility: Retention | Second study visit | Participants lost to follow up in study visit | 3 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Study Feasibility: Retention | First study visit | Participants remaining in study visit | 15 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Study Feasibility: Retention | Third study visit | Participants lost to follow up in study visit | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Study Feasibility: Retention | Third study visit | Participants remaining in study visit | 11 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Study Feasibility: Retention | Second study visit | Participants lost to follow up in study visit | 3 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Study Feasibility: Retention | Second study visit | Participants remaining in study visit | 12 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Study Feasibility: Retention | First study visit | Participants lost to follow up in study visit | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children | Study Feasibility: Retention | Third study visit | Participants lost to follow up in study visit | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children | Study Feasibility: Retention | Second study visit | Participants lost to follow up in study visit | 3 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children | Study Feasibility: Retention | First study visit | Participants remaining in study visit | 15 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children | Study Feasibility: Retention | First study visit | Participants lost to follow up in study visit | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children | Study Feasibility: Retention | Second study visit | Participants remaining in study visit | 12 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children | Study Feasibility: Retention | Third study visit | Participants remaining in study visit | 11 Participants |
Secondary
Change in BMI For Children With BMI Assessments At All Visits
Weight and height were combined to report BMI in kg/m\^2 based on Centers for Disease Control growth curves.
Time frame: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)
Population: Children with BMI data at three study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Both Arms | Change in BMI For Children With BMI Assessments At All Visits | BMI at Baseline | 26.29 kg/m^2 | Standard Deviation 3.07 |
| Both Arms | Change in BMI For Children With BMI Assessments At All Visits | BMI at Visit 2 | 26.64 kg/m^2 | Standard Deviation 2.78 |
| Both Arms | Change in BMI For Children With BMI Assessments At All Visits | BMI at Visit 3 | 26.54 kg/m^2 | Standard Deviation 2.81 |
| Both Arms | Change in BMI For Children With BMI Assessments At All Visits | Change from Baseline at Visit 2 | 0.36 kg/m^2 | Standard Deviation 1.52 |
| Both Arms | Change in BMI For Children With BMI Assessments At All Visits | Change from Baseline at Visit 3 | 0.26 kg/m^2 | Standard Deviation 1.77 |
| Both Arms | Change in BMI For Children With BMI Assessments At All Visits | Change from Visit 2 and Visit 3 | -0.10 kg/m^2 | Standard Deviation 0.62 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI For Children With BMI Assessments At All Visits | Change from Baseline at Visit 3 | -0.16 kg/m^2 | Standard Deviation 0.5 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI For Children With BMI Assessments At All Visits | BMI at Baseline | 24.82 kg/m^2 | Standard Deviation 2.85 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI For Children With BMI Assessments At All Visits | Change from Baseline at Visit 2 | -0.15 kg/m^2 | Standard Deviation 0.59 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI For Children With BMI Assessments At All Visits | BMI at Visit 2 | 24.67 kg/m^2 | Standard Deviation 2.68 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI For Children With BMI Assessments At All Visits | Change from Visit 2 and Visit 3 | -0.01 kg/m^2 | Standard Deviation 0.7 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI For Children With BMI Assessments At All Visits | BMI at Visit 3 | 24.66 kg/m^2 | Standard Deviation 2.81 |
Secondary
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits
Time frame: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)
Population: Children with BMI data at all three study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Both Arms | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMIp95 at Baseline | 117.5 percentage of the 95th percentile | Standard Deviation 12 |
| Both Arms | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMIp95 at Visit 2 | 118.5 percentage of the 95th percentile | Standard Deviation 12 |
| Both Arms | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMIp95 at Visit 3 | 117.3 percentage of the 95th percentile | Standard Deviation 12 |
| Both Arms | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | Change from Baseline at Visit 2 | 1.0 percentage of the 95th percentile | Standard Deviation 7 |
| Both Arms | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | Change from Baseline at Visit 3 | -0.2 percentage of the 95th percentile | Standard Deviation 8 |
| Both Arms | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | Change from Visit 2 to Visit 3 | -1.1 percentage of the 95th percentile | Standard Deviation 3 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | Change from Baseline at Visit 3 | -2.3 percentage of the 95th percentile | Standard Deviation 2 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMIp95 at Baseline | 113.3 percentage of the 95th percentile | Standard Deviation 11 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | Change from Baseline at Visit 2 | -1.5 percentage of the 95th percentile | Standard Deviation 2 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMIp95 at Visit 2 | 111.8 percentage of the 95th percentile | Standard Deviation 12 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | Change from Visit 2 to Visit 3 | -0.8 percentage of the 95th percentile | Standard Deviation 3 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits | BMIp95 at Visit 3 | 111.0 percentage of the 95th percentile | Standard Deviation 12 |
Secondary
Number of Participants With Household Food Insecurity at Second Study Visit
Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Time frame: At second study visit (week 6-8)
Population: Caregivers who reported household-level food security at study visit 2 (week 6-8).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Number of Participants With Household Food Insecurity at Second Study Visit | High | 1 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at Second Study Visit | Marginal food security | 1 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at Second Study Visit | Low food security | 5 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at Second Study Visit | Very low food security | 3 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Second Study Visit | Very low food security | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Second Study Visit | High | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Second Study Visit | Low food security | 8 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Second Study Visit | Marginal food security | 1 Participants |
Secondary
Number of Participants With Household Food Insecurity at the First Study Visit
Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Time frame: At the baseline first study visit (baseline)
Population: Caregivers who reported household-level food security at baseline study visit 1 (baseline).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Number of Participants With Household Food Insecurity at the First Study Visit | High food security | 0 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at the First Study Visit | Marginal food security | 1 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at the First Study Visit | Low food security | 8 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at the First Study Visit | Very low food security | 4 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at the First Study Visit | Very low food security | 4 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at the First Study Visit | High food security | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at the First Study Visit | Low food security | 11 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at the First Study Visit | Marginal food security | 0 Participants |
Secondary
Number of Participants With Household Food Insecurity at Third Study Visit
Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Time frame: At third study visit (week 14-16)
Population: Caregivers who reported household-level food security at third study visit (week 14-16).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Number of Participants With Household Food Insecurity at Third Study Visit | Low food security | 5 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at Third Study Visit | Marginal food security | 0 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at Third Study Visit | Very low food security | 2 Participants |
| Both Arms | Number of Participants With Household Food Insecurity at Third Study Visit | High food security | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Third Study Visit | Very low food security | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Third Study Visit | Low food security | 7 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Third Study Visit | High food security | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Number of Participants With Household Food Insecurity at Third Study Visit | Marginal food security | 1 Participants |
Other Pre-specified
Caregiver Perceived Stress at First Study Visit
The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress
Time frame: At baseline first study visit (baseline)
Population: Caregivers with perceived stress data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Caregiver Perceived Stress at First Study Visit | High perceived stress | 1 Participants |
| Both Arms | Caregiver Perceived Stress at First Study Visit | Moderate perceived stress | 7 Participants |
| Both Arms | Caregiver Perceived Stress at First Study Visit | Low perceived stress | 5 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at First Study Visit | High perceived stress | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at First Study Visit | Moderate perceived stress | 7 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at First Study Visit | Low perceived stress | 7 Participants |
Other Pre-specified
Caregiver Perceived Stress at Second Study Visit
The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress
Time frame: At second study visit (week 6-8)
Population: Caregivers with perceived stress data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Caregiver Perceived Stress at Second Study Visit | High perceived stress | 0 Participants |
| Both Arms | Caregiver Perceived Stress at Second Study Visit | Moderate perceived stress | 5 Participants |
| Both Arms | Caregiver Perceived Stress at Second Study Visit | Low perceived stress | 4 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at Second Study Visit | High perceived stress | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at Second Study Visit | Moderate perceived stress | 5 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at Second Study Visit | Low perceived stress | 7 Participants |
Other Pre-specified
Caregiver Perceived Stress at Third Study Visit
The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress
Time frame: At third study visit (week 14-16)
Population: Caregivers with perceived stress data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Caregiver Perceived Stress at Third Study Visit | High perceived stress | 1 Participants |
| Both Arms | Caregiver Perceived Stress at Third Study Visit | Moderate perceived stress | 3 Participants |
| Both Arms | Caregiver Perceived Stress at Third Study Visit | Low perceived stress | 4 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at Third Study Visit | High perceived stress | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at Third Study Visit | Moderate perceived stress | 5 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Perceived Stress at Third Study Visit | Low perceived stress | 6 Participants |
Other Pre-specified
Caregiver Reported Mealtime Behavior at First Study Visit
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): How often does your child eat dinner together with family members?
Time frame: At baseline first study visit (baseline)
Population: Children with parent-reported data on mealtime behavior.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Caregiver Reported Mealtime Behavior at First Study Visit | Everyday | 5 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at First Study Visit | Never/Less than once per week | 3 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at First Study Visit | Once per week | 0 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at First Study Visit | 2-4 times per week | 5 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at First Study Visit | 5-6 times per week | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at First Study Visit | 5-6 times per week | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at First Study Visit | 2-4 times per week | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at First Study Visit | Never/Less than once per week | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at First Study Visit | Everyday | 10 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at First Study Visit | Once per week | 1 Participants |
Other Pre-specified
Caregiver Reported Mealtime Behavior at Second Study Visit
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): How often does your child eat dinner together with family members?
Time frame: At second study visit (week 6-8)
Population: Children with parent-reported mealtime behavior data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Caregiver Reported Mealtime Behavior at Second Study Visit | Once per week | 0 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Second Study Visit | 5-6 times per week | 2 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Second Study Visit | 2-4 times per week | 5 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Second Study Visit | Everyday | 4 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Second Study Visit | Never/Less than once per week | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Second Study Visit | Everyday | 6 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Second Study Visit | Never/Less than once per week | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Second Study Visit | Once per week | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Second Study Visit | 2-4 times per week | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Second Study Visit | 5-6 times per week | 2 Participants |
Other Pre-specified
Caregiver Reported Mealtime Behavior at Third Study Visit
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): How often does your child eat dinner together with family members?
Time frame: At third study visit (week 14-16)
Population: Children with parent-reported mealtime behavior data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Both Arms | Caregiver Reported Mealtime Behavior at Third Study Visit | Once per week | 2 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Third Study Visit | 5-6 times per week | 0 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Third Study Visit | 2-4 times per week | 5 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Third Study Visit | Everyday | 3 Participants |
| Both Arms | Caregiver Reported Mealtime Behavior at Third Study Visit | Never/Less than once per week | 0 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Third Study Visit | Everyday | 4 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Third Study Visit | Never/Less than once per week | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Third Study Visit | Once per week | 1 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Third Study Visit | 2-4 times per week | 2 Participants |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Caregiver Reported Mealtime Behavior at Third Study Visit | 5-6 times per week | 2 Participants |
Other Pre-specified
Total Prime Diet Quality Score at Each Study Visit: Caregiver
The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.
Time frame: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Population: Parents with dietary data at study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Both Arms | Total Prime Diet Quality Score at Each Study Visit: Caregiver | Caregiver Prime Diet Quality Score (PDQS) at Baseline | 44 score on a scale | Standard Deviation 6 |
| Both Arms | Total Prime Diet Quality Score at Each Study Visit: Caregiver | Caregiver Prime Diet Quality Score (PDQS) at Visit 2 | 48 score on a scale | Standard Deviation 6 |
| Both Arms | Total Prime Diet Quality Score at Each Study Visit: Caregiver | Caregiver Prime Diet Quality Score (PDQS) at Visit 3 | 48 score on a scale | Standard Deviation 5 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Total Prime Diet Quality Score at Each Study Visit: Caregiver | Caregiver Prime Diet Quality Score (PDQS) at Baseline | 42 score on a scale | Standard Deviation 6 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Total Prime Diet Quality Score at Each Study Visit: Caregiver | Caregiver Prime Diet Quality Score (PDQS) at Visit 2 | 46 score on a scale | Standard Deviation 5 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Total Prime Diet Quality Score at Each Study Visit: Caregiver | Caregiver Prime Diet Quality Score (PDQS) at Visit 3 | 47 score on a scale | Standard Deviation 5 |
Other Pre-specified
Total Prime Diet Quality Score at Each Study Visit: Children
The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.
Time frame: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Population: Children with dietary data at study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Both Arms | Total Prime Diet Quality Score at Each Study Visit: Children | Child Prime Diet Quality Score (PDQS) at Baseline | 39 units on a scale | Standard Deviation 6 |
| Both Arms | Total Prime Diet Quality Score at Each Study Visit: Children | Child Prime Diet Quality Score (PDQS) at Visit 2 | 44 units on a scale | Standard Deviation 7 |
| Both Arms | Total Prime Diet Quality Score at Each Study Visit: Children | Child Prime Diet Quality Score (PDQS) at Visit 3 | 44 units on a scale | Standard Deviation 7 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Total Prime Diet Quality Score at Each Study Visit: Children | Child Prime Diet Quality Score (PDQS) at Baseline | 39 units on a scale | Standard Deviation 4 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Total Prime Diet Quality Score at Each Study Visit: Children | Child Prime Diet Quality Score (PDQS) at Visit 2 | 41 units on a scale | Standard Deviation 4 |
| Newsletter + Food Pantry Referral, Then Meal Kit Delivery | Total Prime Diet Quality Score at Each Study Visit: Children | Child Prime Diet Quality Score (PDQS) at Visit 3 | 43 units on a scale | Standard Deviation 4 |