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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Produce prescription program; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	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.
Experimental: Produce prescription program	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body mass index (BMI)	baseline , post intervention (32 weeks after baseline)
Change in systolic blood pressure	baseline , post intervention (32 weeks after baseline)
Change in diastolic blood pressure	baseline , post intervention (32 weeks after baseline)
Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work	baseline , post intervention (32 weeks after baseline)
Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood work	baseline , post intervention (32 weeks after baseline)
Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood work	baseline , post intervention (32 weeks after baseline)
Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood work	baseline , post intervention (32 weeks after baseline)
Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood work	baseline , post intervention (32 weeks after baseline)
Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work	baseline , post intervention (32 weeks after baseline)
Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work	baseline , post intervention (32 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in amount of fruit and vegetable intake	baseline , post intervention (32 weeks after baseline)
Change in amount of junk food consumed	baseline , post intervention (32 weeks after baseline)
Change in number of times subject eats out at restaurants	baseline , post intervention (32 weeks after baseline)
Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch	baseline , post intervention (32 weeks after baseline)
Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions	baseline , post intervention (32 weeks after baseline)
Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child	baseline , post intervention (32 weeks after baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Brighter Bites and Humana Foundation
• Investigators: Principal Investigator: Shreela Sharma, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): February 21, 2026
• Study Completion (Estimated): February 21, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HSC-SPH-24-0129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No