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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05556070
Enrollment
150
Registered
2022-09-27
Start date
2022-10-17
Completion date
2024-11-15
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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)

Interventions

OTHERArm 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.

OTHERArm 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.

OTHERArm 3

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

OTHERBrighter 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.

Sponsors

Brighter Bites
CollaboratorUNKNOWN
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Lipid panelBaseline, 9 months after baseline
Change in Body Mass Index (BMI)Baseline, 9 months after baseline
Change in systolic blood pressureBaseline, 9 months after baseline
Change in diastolic blood pressureBaseline, 9 months after baseline
Change in hemoglobin A1cBaseline, 9 months after baseline
Change in Aspartate transaminase (AST)Baseline, 9 months after baseline
Change in alanine aminotransferase (ALT)Baseline, 9 months after baseline

Secondary

MeasureTime frame
Change in amount of junk food consumedBaseline, 9 months after baseline
Change in number of times subject eats out at restaurantsBaseline, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has cooked food from scratchBaseline, 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 decisionsBaseline, 9 months after baseline
Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent childBaseline, 9 months after baseline
Change in amount of fruit and vegetable intakeBaseline, 9 months after baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026