Impact of a school-based fruit and vegetable program on child and parent health in low-income areas
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
This study is testing whether a program that gives fresh fruits and vegetables to kids and their families can improve their health and eating habits in low-income areas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06570707 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of the Brighter Bites intervention, which provides fresh fruits and vegetables to children and their families, compared to a wait-list control group. It aims to assess changes in primary outcomes such as HbA1c levels and vegetable intake among children, as well as secondary outcomes including household food security and dietary behaviors. The study will also explore how changes in food security and home environment influence child health outcomes over a 9-month period and beyond. The research involves 100 first to third grade students from schools with a high percentage of children on free or reduced lunch programs.
Who should consider this trial
Good fit: Ideal candidates for this study are children in 1st to 3rd grade from low-income families who participate in the free and reduced lunch program.
Not a fit: Children with special needs or disabilities that prevent participation in evaluation measures will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve dietary habits and metabolic health in children and their families living in poverty.
How similar studies have performed: Other studies have shown positive outcomes with similar school-based nutrition interventions, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Shreela Sharma, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Shreela Sharma, PhD
- Email: Shreela.V.Sharma@uth.tmc.edu
- Phone: (713) 500-9344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.