Brighter Bites & UT Physicians Produce Rx Program

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Other: Arm 3; Other: Arm 2; Other: Arm 1; Other: Brighter Bites app

• Registration Number: NCT05556070
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2022-10-17
• Primary Completion: 2024-07-31
• Study Completion: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Arm 3	-
Arm 2	Arm 2	-
Arm 2	Brighter Bites app	-
Arm 1	Brighter Bites app	-
Arm 1	Arm 1	-

Primary Outcome Measures

Name	Time	Method
Change in alanine aminotransferase (ALT)	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 Body Mass Index (BMI)	Baseline, 9 months after baseline
Change in systolic blood pressure	Baseline, 9 months after baseline
Change in Lipid panel	Baseline, 9 months after baseline
Change in diastolic blood pressure	Baseline, 9 months after baseline

Secondary Outcome Measures

Name	Time	Method
Change in amount of fruit and vegetable intake	Baseline, 9 months after baseline
Change in number of times subject eats out at restaurants	Baseline, 9 months after baseline
Change in amount of junk food consumed	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
Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch	Baseline, 9 months after baseline

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States