Actively Recruiting
Cluster-Randomized Controlled Trial to Evaluate a School-based Fruit and Vegetable Co-op Impact on Cardiometabolic Health of Children and Parents in a Persistent Poverty Area
Led by The University of Texas Health Science Center, Houston · Updated on 2025-07-08
720
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of the Brighter Bites (BB) intervention on children's cardiometabolic health and dietary habits in a persistent poverty area. Specifically, it compares changes in primary child outcomes such as HbA1c levels and vegetable intake between the intervention and a wait-list control group. The study also assesses secondary outcomes like household food security, parent and child dietary behaviors, and home availability of fruits and vegetables, while exploring how these factors influence child health outcomes over time. Participants in the intervention group receive fresh fruit and vegetable distributions of about 20 pounds per family for around 16 weeks during the school year, combined with nutrition education through the Coordinated Approach to Child Health (CATCH) program for children and bilingual nutrition handbooks plus healthy recipe tastings for parents and families. A delayed intervention group will receive the same Brighter Bites program after their study participation ends. The study includes follow-up assessments up to 21 months to observe long-term effects and dose-response relationships. During the study, children and parents undergo evaluations including measuring child HbA1c, vegetable intake using the VEGGIE METER®, blood pressure, and surveys assessing food security, dietary habits, and home fruit and vegetable availability. Data are collected at baseline, post-intervention at 9 months, and follow-up at 21 months. The study monitors changes in these health and behavioral measures to understand the impact of the intervention on diet, adiposity, and metabolic outcomes in children and parents.
CONDITIONS
Brief Title
Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment of 100 students in 1st, 2nd, and 3rd grade
- High proportion (over 70%) of children participating in the free and reduced lunch program
- Willingness of school to implement a coordinated school health program
You will not qualify if you...
- Prior participation in Brighter Bites in the previous school year
- Children or parents identified as special needs by the school
- Any physical, cognitive, or psychological disability preventing participation in evaluation measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants in the intervention group receive fresh fruits and vegetables distributions for about 16 weeks during the school year, along with nutrition education for children and parents.
Weekly visits for produce pick-up and nutrition education activities
Duration - 9 months
Participants are followed for 9 months after the intervention to assess changes in health outcomes such as child HbA1c levels, vegetable intake, household food security, and dietary behaviors.
1 visit at 9 months post intervention
Duration - Up to 21 months from baseline
Participants are assessed again for long-term effects of the intervention on diet, adiposity, and metabolic outcomes at about 21 months after baseline.
1 visit at 21 months follow-up
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Shreela Sharma, PhD
E
Emily Adlparvar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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