Actively Recruiting

Phase Not Applicable
Age: 6Years - 9Years
All Genders
ID06570707

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

Age: 6Years - 9Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Intervention

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

Post-intervention Follow-up

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

Long-term Monitoring

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

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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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