Brighter Bites & UT Physicians Produce Rx Program

NCT05556070 | Completed

• 1 other identifier: HSC-SPH-22-0629
• 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 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)

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• 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

Study Arms (3)

Arm 1

EXPERIMENTAL

Other: Arm 1; Other: Brighter Bites app

Arm 2

EXPERIMENTAL

Other: Arm 2; Other: Brighter Bites app

Arm 3

ACTIVE COMPARATOR

Other: Arm 3

Interventions

Arm 1 OTHER

: 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 1

Arm 2 OTHER

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 2

Arm 3 OTHER

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

Arm 3

Brighter Bites app OTHER

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.

Arm 1; Arm 2

Eligibility Criteria

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

You may qualify if:

• 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
• with 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: 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

DMAC2L protein, human

Condition Hierarchy (Ancestors)

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

Study Officials

• Christine Markham, 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: September 22, 2022
• First Posted: September 27, 2022
• Study Start: October 17, 2022
• Primary Completion: July 31, 2024
• Study Completion: November 15, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)