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

NCT ID: NCT06570707

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-08

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Child Obesity Cardiometabolic Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Brighter Bites

Intervention Type 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.

Control group

This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Shreela V Sharma

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shreela Sharma, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shreela Sharma, PhD

Role: CONTACT

(713) 500-9344

Emily Adlparvar

Role: CONTACT

(713) 500 9608

Facility Contacts

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Shreela Sharma, PhD

Role: primary

713-500-9344

Emily Adlparvar

Role: backup

(713) 500 9608

Other Identifiers

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5U54CA280804-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-23-0282

Identifier Type: -

Identifier Source: org_study_id

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