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Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area

Cluster-Randomized Controlled Trial (RCT) to Evaluate the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Health of Children and Parents in a Persistent Poverty Area

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06570707
Enrollment
720
Registered
2024-08-26
Start date
2024-08-08
Completion date
2027-06-30
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Health, Child Obesity

Keywords

Brighter Bites

Brief summary

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

Detailed description

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Interventions

Families will receive a distribution of fresh fruits and vegetables (FV) (\ 20lbs., 50 servings/family/distribution) for \ 16 weeks during the school year using primarily donated produce from local food banks. Nutrition education will be implemented for children using the evidence-based Coordinated Approach to Child Health (CATCH) program and for parents using bilingual nutrition handbooks and fun food experiences such as healthy FV recipe tastings for families during produce pick-up time will be conducted.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

* enrollment of 100 1st, 2nd, and 3rd grade students * high proportion of children participating in the free and reduced lunch (FRL) program (\>70%) * willingness to implement a coordinated school health (CSH) program

Exclusion criteria

* Prior participation in BB in the previous school year * children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures

Design outcomes

Primary

MeasureTime frameDescription
Change in level of child Glycosylated hemoglobin (HbA1c)baseline, post intervention (9 months after baseline)We will utilize the portable HbA1c analyzers (DCA Vantage analyzer) to assess HbA1c, during biometric events.
Change in amount of child vegetable intake as assessed by the VEGGIE METER®baseline, post intervention (9 months after baseline)The VEGGIE METER® is used to obtain a child's quantitative metric of skin carotenoids, a proxy measure of FV intake for children. The VEGGIE METER® measures skin carotenoids as an indicator of FV intake. Higher number of carotenoid levels indicate more FV intake.

Secondary

MeasureTime frameDescription
Number of servings consumed by the parent as assessed by the Adapted Health of Houston Survey (HHS) on processed food/drinks 4-items, and fruit and vegetable intake 2 items.baseline, post intervention (9 months after baseline)This is a 6-item questionnaire. The parent responds the number of servings they consumed during the time period. Servings are calculated based on the servings per day.
Child systolic blood pressurebaselineChild's systolic blood pressure will be obtained with an automatic cuff according to recommendations of the American Heart Association. This will be measure during biometric events.
Number of servings consumed by the Child as assessed by the NIH's Eating at America's Table questionnaire (All Day) and the Dietary Screener Questionnairesbaseline, post intervention (9 months after baseline)This is a 6-item questionnaire. The parent responds the number of servings their child consumed during the time period. Servings are calculated based on the servings per day.
Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnairebaseline, post intervention (9 months after baseline)Nutrition security measures assess factors associated with a household's ability to obtain foods that meet their nutritional and health needs. Household Food Insecurity will be measured using 2-item Hunger Vital Sign food security survey and 4-items adapted from the Center for Nutrition and Health Impact, for a total of 6-items. The items are scored from 0 (if the participant selects Always) to 4 (if the participant selects Never) and the measure's score is the mean of the responses. The higher the participant's score, the greater degree of the household nutrition security.
Child diastolic blood pressurebaselineChild's diastolic blood pressure will be obtained with an automatic cuff. This will be measure during biometric events.
Change in household food security status as assessed by a parent surveybaseline, post intervention (9 months after baseline)Household Food Insecurity will be measured using 2-item Hunger Vital Sign food security survey and 4-items adapted from the Center for Nutrition and Health Impact, for a total of 6-items. The items are scored from 0 (if the participant selects Always) to 4 (if the participant selects Never) and the measure's score is the mean of the responses. The higher the participant's score, the greater degree of the household nutrition security.

Countries

United States

Contacts

Primary ContactShreela Sharma, PhD
Shreela.V.Sharma@uth.tmc.edu(713) 500-9344
Backup ContactEmily Adlparvar
Emily.M.Adlparvar@uth.tmc.edu(713) 500 9608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026