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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390397
• Other study ID #: HSC-SPH-24-0129
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: February 21, 2026

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Shreela Sharma, PhD
• Phone: (713) 500-9344
• Email: Shreela.V.Sharma[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 21, 2026
• Est. primary completion date: December 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Brighter Bites and Humana Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index (BMI)		baseline , post intervention (32 weeks after baseline)
Primary	Change in systolic blood pressure		baseline , post intervention (32 weeks after baseline)
Primary	Change in diastolic blood pressure		baseline , post intervention (32 weeks after baseline)
Primary	Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work		baseline , post intervention (32 weeks after baseline)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work		baseline , post intervention (32 weeks after baseline)
Primary	Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work		baseline , post intervention (32 weeks after baseline)
Secondary	Change in amount of fruit and vegetable intake		baseline , post intervention (32 weeks after baseline)
Secondary	Change in amount of junk food consumed		baseline , post intervention (32 weeks after baseline)
Secondary	Change in number of times subject eats out at restaurants		baseline , post intervention (32 weeks after baseline)
Secondary	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)
Secondary	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)
Secondary	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)