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

NCT06390397 | Active Not Recruiting

• 1 other identifier: HSC-SPH-24-0129
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (6)

• 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)

Study Arms (2)

Produce prescription program

EXPERIMENTAL

Other: Produce prescription program; Other: Standard of care

Standard of Care

ACTIVE COMPARATOR

Other: Standard of care

Interventions

Produce prescription program 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.

Produce prescription program

Standard of care 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.

Produce prescription program; Standard of Care

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Brighter Bites and Humana Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shreela Sharma, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: April 22, 2024
• Primary Completion: February 21, 2026
• Study Completion: February 21, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)