Brighter Bites & UT Physicians Produce Rx Program

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556070
• Other study ID #: HSC-SPH-22-0629
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Christine Markham, PhD
• Phone: 713-500-9646
• Email: Christine.Markham[@]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 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.
• Arm 3
subjects in this arm will receive the usual standard of care at the clinic for the study period
• 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.

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI)		Baseline, 9 months after baseline
Primary	Change in systolic blood pressure		Baseline, 9 months after baseline
Primary	Change in diastolic blood pressure		Baseline, 9 months after baseline
Primary	Change in hemoglobin A1c		Baseline, 9 months after baseline
Primary	Change in Aspartate transaminase (AST)		Baseline, 9 months after baseline
Primary	Change in alanine aminotransferase (ALT)		Baseline, 9 months after baseline
Primary	Change in Lipid panel		Baseline, 9 months after baseline
Secondary	Change in amount of fruit and vegetable intake		Baseline, 9 months after baseline
Secondary	Change in amount of junk food consumed		Baseline, 9 months after baseline
Secondary	Change in number of times subject eats out at restaurants		Baseline, 9 months after baseline
Secondary	Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch		Baseline, 9 months 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, 9 months after baseline
Secondary	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