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Brighter Bites & UT Physicians Produce Rx Program

Primary Purpose

Obesity, Childhood

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Arm 1

Arm 2

Arm 3

Brighter Bites app

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)

Change in systolic blood pressure

Change in diastolic blood pressure

Change in hemoglobin A1c

Change in Aspartate transaminase (AST)

Change in alanine aminotransferase (ALT)

Change in Lipid panel

Secondary Outcome Measures

Change in amount of fruit and vegetable intake

Change in amount of junk food consumed

Change in number of times subject eats out at restaurants

Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch

Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions

Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child

Full Information

NCT ID

NCT05556070

First Posted

September 22, 2022

Last Updated

October 17, 2022

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Brighter Bites

1. Study Identification

Unique Protocol Identification Number

NCT05556070

Brief Title

Brighter Bites & UT Physicians Produce Rx Program

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 17, 2022 (Actual)

Primary Completion Date

July 31, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Brighter Bites

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Childhood

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Arm 1

Intervention Description

: 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.

Intervention Type

Other

Intervention Name(s)

Arm 2

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Arm 3

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Brighter Bites app

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Body Mass Index (BMI)

Time Frame