An interventional study of Meal Kit Delivery and Newsletter + Food Pantry Referral in Pediatric Obesity, Nutrition Disorders and Overnutrition, Child, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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Among 557 studies in Pediatric Obesity with a site in United States — 74 open to participants now, 109 under way, 3 of them phase 3. Pediatric Obesity · United States.
Among the 557 studies in Pediatric Obesity with a site in United States, this one is the 300th largest by enrollment of the 474 interventional ones that give a count, is one of 44 that started in 2023, is one of 422 with no phase, and was the 442nd registered.
1,130 studies on the registry are indexed under Pediatric Obesity; 184 are open to participants now.
Browse Pediatric Obesity studies →74 of the 557 studies in Pediatric Obesity with a site in United States are open now. Recruiting first, the newest first:
Stanford University · Sites in United States
Ages 10–15
Children's Hospital Los Angeles · Sites in United States
Ages 12–18
Virginia Commonwealth University · Sites in United States
Ages 12–15 · Healthy volunteers
University of Michigan · Sites in United States
Ages 4 mo+ · Healthy volunteers
Russell McCulloh, MD · Sites in United States
Ages 12–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 121 Pediatric Obesity studies recruiting now, 17 (14%) set no upper age limit and 102 (84%) stop at 75 or younger; 112 take children under 18; 68 take healthy volunteers.
This study: 6 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
557 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 27 · Phase 3 10 · Phase 4 11
First in 1998; this study’s year is marked. 44 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 59 is below the median of 100 across 871 interventional studies indexed under Pediatric Obesity.
Median enrollment 95 across the 474 interventional studies, 120 across the 81 observational. Of the 418 that completed or were terminated, 116 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 557 have an industry lead sponsor. The 10 most frequent:
Boston Children's Hospital is the lead sponsor of 609 studies on the registry; 148 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Boston Children's Hospital has 3 studies filed under Pediatric Obesity — fewer than ten, so there is no comparison to draw.
40 of the studies in Pediatric Obesity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04974554Medical University of South CarolinaFIT Families Multicomponent Obesity Intervention for African American Adolescents | 2026-11-30 |
| NCT06810557Temple UniversityBrief Behavioral Sleep Intervention for Obesity Prevention in Primary Care | 2026-11-30 |
| NCT04971044Vanderbilt University Medical CenterCompetency Based Approaches for Community Health 2 | 2026-12 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT04128995Children's Hospital Medical Center, CincinnatiSurgical or Medical Treatment | 2026-12 |
Add all 40 to your calendar (.ics) → With an account.
Among the 557 studies in Pediatric Obesity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Child Inclusion Criteria:
Child Exclusion Criteria:
The child's primary caregiver will be eligible for enrollment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Meal Kit Delivery · Behavioral: Newsletter + Food Pantry Referral
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).
Behavioral: Meal Kit Delivery · Behavioral: Newsletter + Food Pantry Referral
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.
Also known as: EatWell Meal Kits
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.
Also known as: Standard of Care
Study Feasibility: Recruitment
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
Time frame: 2 months to baseline
Study Feasibility: Randomization
Number of participants enrolled per month, then subject to randomization.
Time frame: At baseline
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).
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)
Study Feasibility: Adherence - Caregivers
Total number of recipes prepared by caregivers
Time frame: Third study visit (week 14-16)
Study Feasibility: Adherence - Children
Number of children who tasted/ate food from the meal kit
Time frame: Third study visit (week 14-16)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
| Milestone | Meal Kits, Then Newsletter + Food Pantry Referral: Caregivers | Meal Kits, Then Newsletter + Food Pantry Referral: Children | Newsletter + Food Pantry Referral, Then Meal Kits: Caregivers | Newsletter + Food Pantry Referral, Then Meal Kits: Children |
|---|---|---|---|---|
| Started | 14 | 15 | 15 | 15 |
| Received intervention | 13 | 14 | 15 | 15 |
| Completed | 10 | 11 | 12 | 12 |
| Not completed | 4 | 4 | 3 | 3 |
| Withdrew: Lost to follow-up | 4 | 4 | 3 | 3 |
| Milestone | Meal Kits, Then Newsletter + Food Pantry Referral: Caregivers | Meal Kits, Then Newsletter + Food Pantry Referral: Children | Newsletter + Food Pantry Referral, Then Meal Kits: Caregivers | Newsletter + Food Pantry Referral, Then Meal Kits: Children |
|---|---|---|---|---|
| Started | 10 | 11 | 12 | 12 |
| Completed | 10 | 11 | 11 | 11 |
| Not completed | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 |
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
| Participants | Both Arms |
|---|---|
| Enrolled | 59 |
| Declined to enroll | 10 |
Number of participants enrolled per month, then subject to randomization.
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Number of participants enrolled (February) | 20 | 20 |
| Number of participants enrolled (March) | 9 | 10 |
Number of participants retained at each study visit
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver | Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children | Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver | Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children |
|---|---|---|---|---|
| First study visit — Participants remaining in study visit | 13 | 14 | 15 | 15 |
| First study visit — Participants lost to follow up in study visit | 1 | 1 | 0 | 0 |
| Second study visit — Participants remaining in study visit | 10 | 11 | 12 | 12 |
| Second study visit — Participants lost to follow up in study visit | 3 | 3 | 3 | 3 |
| Third study visit — Participants remaining in study visit | 10 | 11 | 11 | 11 |
| Third study visit — Participants lost to follow up in study visit | 0 | 0 | 1 | 1 |
Number of participants who reported receipt of all six weeks of meal kit delivery
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Study Feasibility: Protocol | 19 | 22 |
Total number of recipes prepared by caregivers
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Caregivers who prepared 7-12 recipes | 3 | 2 |
| Caregivers who prepared 3-6 recipes | 4 | 4 |
| Caregivers who prepared 1-2 recipes | 2 | 5 |
| Caregivers who did not prepare any recipe | 1 | 0 |
Number of children who tasted/ate food from the meal kit
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Study Feasibility: Adherence - Children | 10 | 11 |
Proportion of planned assessments completed at each study visit
| Survey/Assessments | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Planned assessments completed after visit 1 | 56 | 60 |
| Planned assessments completed after visit 2 | 32 | 35 |
| Planned assessments completed after visit 3 | 38 | 43 |
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
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| High food security | 0 | 0 |
| Marginal food security | 1 | 0 |
| Low food security | 8 | 11 |
| Very low food security | 4 | 4 |
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
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| High | 1 | 1 |
| Marginal food security | 1 | 1 |
| Low food security | 5 | 8 |
| Very low food security | 3 | 2 |
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
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| High food security | 2 | 2 |
| Marginal food security | 0 | 1 |
| Low food security | 5 | 7 |
| Very low food security | 2 | 1 |
Weight and height were combined to report BMI in kg/m\^2 based on Centers for Disease Control growth curves.
| kg/m^2 | Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers | Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers |
|---|---|---|
| BMI at Baseline | 26.29 ± 3.07 | 24.82 ± 2.85 |
| BMI at Visit 2 | 26.64 ± 2.78 | 24.67 ± 2.68 |
| BMI at Visit 3 | 26.54 ± 2.81 | 24.66 ± 2.81 |
| Change from Baseline at Visit 2 | 0.36 ± 1.52 | -0.15 ± 0.59 |
| Change from Baseline at Visit 3 | 0.26 ± 1.77 | -0.16 ± 0.50 |
| Change from Visit 2 and Visit 3 | -0.10 ± 0.62 | -0.01 ± 0.70 |
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
| percentage of the 95th percentile | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| BMIp95 at Baseline | 117.5 ± 12 | 113.3 ± 11 |
| BMIp95 at Visit 2 | 118.5 ± 12 | 111.8 ± 12 |
| BMIp95 at Visit 3 | 117.3 ± 12 | 111.0 ± 12 |
| Change from Baseline at Visit 2 | 1.0 ± 7 | -1.5 ± 2 |
| Change from Baseline at Visit 3 | -0.2 ± 8 | -2.3 ± 2 |
| Change from Visit 2 to Visit 3 | -1.1 ± 3 | -0.8 ± 3 |
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.
| units on a scale | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Child Prime Diet Quality Score (PDQS) at Baseline | 39 ± 6 | 39 ± 4 |
| Child Prime Diet Quality Score (PDQS) at Visit 2 | 44 ± 7 | 41 ± 4 |
| Child Prime Diet Quality Score (PDQS) at Visit 3 | 44 ± 7 | 43 ± 4 |
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.
| score on a scale | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Caregiver Prime Diet Quality Score (PDQS) at Baseline | 44 ± 6 | 42 ± 6 |
| Caregiver Prime Diet Quality Score (PDQS) at Visit 2 | 48 ± 6 | 46 ± 5 |
| Caregiver Prime Diet Quality Score (PDQS) at Visit 3 | 48 ± 5 | 47 ± 5 |
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Never/Less than once per week | 3 | 1 |
| Once per week | 0 | 1 |
| 2-4 times per week | 5 | 2 |
| 5-6 times per week | 1 | 1 |
| Everyday | 5 | 10 |
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Never/Less than once per week | 0 | 1 |
| Once per week | 0 | 1 |
| 2-4 times per week | 5 | 2 |
| 5-6 times per week | 2 | 2 |
| Everyday | 4 | 6 |
Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| Never/Less than once per week | 0 | 2 |
| Once per week | 2 | 1 |
| 2-4 times per week | 5 | 2 |
| 5-6 times per week | 0 | 2 |
| Everyday | 3 | 4 |
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
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| High perceived stress | 1 | 0 |
| Moderate perceived stress | 7 | 7 |
| Low perceived stress | 5 | 7 |
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
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| High perceived stress | 0 | 0 |
| Moderate perceived stress | 5 | 5 |
| Low perceived stress | 4 | 7 |
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
| Participants | Meal Kit Delivery, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kit Delivery |
|---|---|---|
| High perceived stress | 1 | 0 |
| Moderate perceived stress | 3 | 5 |
| Low perceived stress | 4 | 6 |
Collected over Six weeks for each intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Meal Kit Delivery: Caregivers | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Meal Kit Delivery: Children | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Newsletter + Food Pantry Referral: Caregivers | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Newsletter + Food Pantry Referral: Children | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
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.
| Age, Continuous(years) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Child age | 10 (6 to 11) | 9 (6 to 11) | 9 (6 to 11) |
| Caregiver age | 42 (27 to 50) | 39 (31 to 50) | 42 (27 to 50) |
| Sex: Female, Male(Participants) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Child sex — Female | 5 | 8 | 13 |
| Child sex — Male | 10 | 7 | 17 |
| Caregiver sex — Female | 12 | 13 | 25 |
| Caregiver sex — Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Child ethnicity — Hispanic or Latino | 11 | 15 | 26 |
| Child ethnicity — Not Hispanic or Latino | 3 | 0 | 3 |
| Child ethnicity — Unknown or Not Reported | 1 | 0 | 1 |
| Caregiver ethnicity — Hispanic or Latino | 9 | 15 | 24 |
| Caregiver ethnicity — Not Hispanic or Latino | 4 | 0 | 4 |
| Caregiver ethnicity — Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Child race — American Indian or Alaska Native | 1 | 1 | 2 |
| Child race — Asian | 0 | 0 | 0 |
| Child race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Child race — Black or African American | 7 | 6 | 13 |
| Child race — White | 3 | 4 | 7 |
| Child race — More than one race | 1 | 0 | 1 |
| Child race — Unknown or Not Reported | 3 | 3 | 6 |
| Caregiver race — American Indian or Alaska Native | 1 | 1 | 2 |
| Caregiver race — Asian | 0 | 0 | 0 |
| Caregiver race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Caregiver race — Black or African American | 6 | 5 | 11 |
| Caregiver race — White | 3 | 3 | 6 |
| Caregiver race — More than one race | 1 | 0 | 1 |
| Caregiver race — Unknown or Not Reported | 3 | 5 | 8 |
| Number of people living in the household(persons) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Number of adults 18 years and older | 2 (1 to 3) | 2 (1 to 3) | 2 (1 to 3) |
| Number of children younger than 18 years | 2 (1 to 4) | 2 (1 to 4) | 2 (1 to 4) |
| Caregiver marital status(Participants) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Married | 3 | 3 | 6 |
| Never married | 5 | 2 | 7 |
| Divorced | 1 | 3 | 4 |
| Separated | 3 | 4 | 7 |
| Widowed | 1 | 0 | 1 |
| Prefer not to answer | 0 | 3 | 3 |
| Missing | 1 | 0 | 1 |
| Total annual household income(Participants) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| Less than $20,000 | 7 | 10 | 17 |
| Between $20,000 and $70,000 | 2 | 3 | 5 |
| More than $70,000 | 2 | 0 | 2 |
| Don't know | 2 | 1 | 3 |
| Prefer not to answer | 0 | 1 | 1 |
| Missing | 1 | 0 | 1 |
| Highest grade or degree completed(Participants) | Meal Kits, Then Newsletter + Food Pantry Referral | Newsletter + Food Pantry Referral, Then Meal Kits | Total |
|---|---|---|---|
| 8th grade or less | 2 | 2 | 4 |
| Some high school | 2 | 6 | 8 |
| High school graduate | 3 | 4 | 7 |
| Some college or technical school | 2 | 1 | 3 |
| College graduate | 3 | 2 | 5 |
| Postgraduate training or degree | 1 | 0 | 1 |
| Don't know or prefer not to answer | 0 | 0 | 0 |
| Missing | 1 | 0 | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, Institutional Review Board approval has been obtained, and all necessary data sharing agreements have been executed.
Supporting information: Study protocol, Informed consent form
Time frame: Data can be requested by emailing the PI.
Access criteria: An analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and All necessary data sharing agreements have been executed.
Ran from Feb 2023 to primary completion in Nov 2023, 8 months.
Results were first posted in May 2025, 1 year 6 months after primary completion.
Of 541 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 8 months is below that.
Counting every sponsor, half of 543 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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