Brighter Bites & UT Physicians Produce Rx Program

Study Overview
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Brief Summary
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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)

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

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Other: Arm 1
* Other: Arm 2
* Other: Arm 3
* Other: Brighter Bites app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Other: Arm 1<br>* : 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.<br>Other: Brighter Bites app<br>* 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.<br>|
| Experimental: Arm 2<br> | Other: Arm 2<br>* 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.<br>Other: Brighter Bites app<br>* 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.<br>|
| Active Comparator: Arm 3<br> | Other: Arm 3<br>* subjects in this arm will receive the usual standard of care at the clinic for the study period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |