Brighter Bites & UT Physicians Produce Rx Program

Brighter Bites & University of Texas Physicians Produce Rx: 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 produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group 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: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Arm 1; Other: Brighter Bites app; Other: Arm 2; Other: Arm 3

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

Contacts and Locations

• Study Contact: Name: Christine Markham, PhD; Phone Number: 713-500-9646; Email: Christine.Markham@uth.tmc.edu
• Study Contact Backup: Name: Mallika Mathur; Phone Number: 713-500-9000; Email: Mallika.Mathur@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Christine Markham, PhD; Phone Number: 713-500-9646; Email: Christine.Markham@uth.tmc.edu
      • Contact: Mallika Mathur; Phone Number: 713-500-9000; Email: Mallika.Mathur@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• with 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
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Other: Arm 1; : Local retailer produce vouchers ($25 value) will be distributed to the families biweekly over a 32-week period for a total of 16 vouchers. The vouchers can be redeemed for fresh produce at the grocery store that issued the vouchers.; Other: Brighter Bites app; Participants in Arms 1 and 2 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.
EXPERIMENTAL: Arm 2	Other: Brighter Bites app; Participants in Arms 1 and 2 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: Arm 2; Boxes of fresh fruits 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.
ACTIVE_COMPARATOR: Arm 3	Other: Arm 3; subjects in this arm will receive the usual standard of care at the clinic for the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Body Mass Index (BMI)	Baseline, 9 months after baseline
Change in systolic blood pressure	Baseline, 9 months after baseline
Change in diastolic blood pressure	Baseline, 9 months after baseline
Change in hemoglobin A1c	Baseline, 9 months after baseline
Change in Aspartate transaminase (AST)	Baseline, 9 months after baseline
Change in alanine aminotransferase (ALT)	Baseline, 9 months after baseline
Change in Lipid panel	Baseline, 9 months after baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in amount of fruit and vegetable intake	Baseline, 9 months after baseline
Change in amount of junk food consumed	Baseline, 9 months after baseline
Change in number of times subject eats out at restaurants	Baseline, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch	Baseline, 9 months 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, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child	Baseline, 9 months after baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Brighter Bites

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2022
• Primary Completion (ANTICIPATED): July 31, 2023
• Study Completion (ANTICIPATED): August 30, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (ACTUAL): September 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HSC-SPH-22-0629

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