Recruiting

Fruit & Vegetable Co-op

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06570707

Conditions

Child Obesity

Cardiometabolic Health

Eligibility Criteria

Sex: All

Age: 6 - 9

Healthy Volunteers: Not accepted

Interventions

Brighter Bites

Study Details

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

Study ID

NCT06570707

Start date

Aug 8, 2024

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 9

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Brighter Bites

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.

no intervention: Control group

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

Interventions

Brighter Bites

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.

Primary outcome measure

  • Change in level of child Glycosylated hemoglobin (HbA1c) [ Time Frame: baseline, post intervention (9 months after baseline) ]
  • Change in amount of child vegetable intake as assessed by the VEGGIE METER® [ Time Frame: baseline, post intervention (9 months after baseline) ]

Central Contacts and Locations

Central contacts

Shreela Sharma, PhD

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

Emily Adlparvar

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Shreela Sharma, PhD

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

Emily Adlparvar

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 8, 2025

Last verified

Jul, 2025

Keywords

  • Brighter Bites

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-07-08.