Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions

NCT ID: NCT06390397

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2026-02-21

Brief Summary

The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child).

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Produce prescription program

Group Type: EXPERIMENTAL

Produce prescription program

Intervention Type: OTHER

Boxes of fresh fruit and vegetables (F\&V), each containing approximately 50 servings of F\&V, will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F\&V boxes will be distributed to families every 2 weeks over 32 weeks. Participants will also receive nutrition education using the Brighter Bites app which includes recipes for a variety of meal types or produce types, all of which are searchable. Recipes include the average cost to prepare, the number of servings, and the calories for the recipe. The Brighter Bites app also includes healthy living "Brighter Choices" suggestions such as tips for how to store different types of foods, gardening tips, and tips to pack a healthy lunchbox. In addition to the Brighter Bites app, trained staff will facilitate virtual nutrition education for patient families.

Standard of care

Intervention Type: OTHER

Standard of care includes routine lab work collection and weight and diet counseling for overweight or obese children. Additionally, referrals placed to community resources for those identified with Social Determinants of Health(SDOH) needs.

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard of care includes routine lab work collection and weight and diet counseling for overweight or obese children. Additionally, referrals placed to community resources for those identified with Social Determinants of Health(SDOH) needs.

Interventions

Produce prescription program

Boxes of fresh fruit and vegetables (F\&V), each containing approximately 50 servings of F\&V, will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F\&V boxes will be distributed to families every 2 weeks over 32 weeks. Participants will also receive nutrition education using the Brighter Bites app which includes recipes for a variety of meal types or produce types, all of which are searchable. Recipes include the average cost to prepare, the number of servings, and the calories for the recipe. The Brighter Bites app also includes healthy living "Brighter Choices" suggestions such as tips for how to store different types of foods, gardening tips, and tips to pack a healthy lunchbox. In addition to the Brighter Bites app, trained staff will facilitate virtual nutrition education for patient families.

Intervention Type: OTHER

Standard of care

Standard of care includes routine lab work collection and weight and diet counseling for overweight or obese children. Additionally, referrals placed to community resources for those identified with Social Determinants of Health(SDOH) needs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Must be a patient at University of Texas Physicians Greens Clinic or University of Texas Physicians Pediatric Primary Care in Houston, Texas
• BMI>85th percentile
• reside within a 10-mile radius of a Brighter Bites school
• Medicaid recipients or low-income uninsured
• parents must be able to read and write in English or Spanish to complete surveys

Exclusion Criteria

• currently participating in Brighter Bites
• a family member/sibling currently participating in Brighter Bites
• child is currently attending a school that offers Brighter Bites

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brighter Bites and Humana Foundation

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Shreela V Sharma

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shreela Sharma, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-SPH-24-0129

Identifier Type: -

Identifier Source: org_study_id