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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06570707
Status
Recruiting
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Conditions

  • Cardiometabolic Health
  • Child Obesity

Eligibility Criteria

Sex
ALL
Age
6 Years - 9 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 8, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
720 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Change in level of child Glycosylated hemoglobin (HbA1c) [ Time Frame: baseline, post intervention (9 months after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Shreela Sharma, PhD
[email protected]
713-500-9344
Emily Adlparvar
[email protected]
(713) 500 9608

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