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

NCT06570707 | Recruiting

• 2 other identifiers: HSC-SPH-23-02825U54CA280804-02
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Obesity; Cardiometabolic Health

Keywords

Brighter Bites

Outcome Measures

Primary Outcomes (2)

• Change in level of child Glycosylated hemoglobin (HbA1c)

  We will utilize the portable HbA1c analyzers (DCA Vantage analyzer) to assess HbA1c, during biometric events.

  baseline, post intervention (9 months after baseline)

• Change in amount of child vegetable intake as assessed by the VEGGIE METER®

  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.

  baseline, post intervention (9 months after baseline)

Secondary Outcomes (8)

• Change in household food security status as assessed by a parent survey

  baseline, post intervention (9 months after baseline)

• 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)

• 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 Questionnaires

  baseline, post intervention (9 months after baseline)

• Child systolic blood pressure

  baseline

• Child systolic blood pressure

  Post intervention (9 months after baseline)

Study Arms (2)

Brighter Bites

EXPERIMENTAL

This group will receive the Brighter Bites intervention throughout the study implementation. The intervention includes fruit and vegetable distributions of \~20lbs. for teachers and families, healthy recipe tastings, and nutrition education.

Other: Brighter Bites

Control group

NO INTERVENTION

This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.

Interventions

Brighter Bites OTHER

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.

Brighter Bites

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shreela Sharma, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreela Sharma, PhD

CONTACT

(713) 500-9344; Shreela.V.Sharma@uth.tmc.edu

Emily Adlparvar

CONTACT

(713) 500 9608; Emily.M.Adlparvar@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 26, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)