NCT06570707

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Conditions

• Child Obesity
• Cardiometabolic Health

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-08-08
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-08-26
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States