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OpenTrials
Completed

NCT Number: NCT05556070

Brighter Bites & UT Physicians Produce Rx Program

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)

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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 3

Other

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

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.

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline, 9 months after baseline

  2. Change in systolic blood pressure

    Time frame: Baseline, 9 months after baseline

  3. Change in diastolic blood pressure

    Time frame: Baseline, 9 months after baseline

  4. Change in hemoglobin A1c

    Time frame: Baseline, 9 months after baseline

  5. Change in Aspartate transaminase (AST)

    Time frame: Baseline, 9 months after baseline

  6. Change in alanine aminotransferase (ALT)

    Time frame: Baseline, 9 months after baseline

  7. Change in Lipid panel

    Time frame: Baseline, 9 months after baseline

Secondary outcomes

  1. Change in amount of fruit and vegetable intake

    Time frame: Baseline, 9 months after baseline

  2. Change in amount of junk food consumed

    Time frame: Baseline, 9 months after baseline

  3. Change in number of times subject eats out at restaurants

    Time frame: Baseline, 9 months after baseline

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

    Time frame: Baseline, 9 months after baseline

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

    Time frame: Baseline, 9 months after baseline

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

    Time frame: Baseline, 9 months after baseline

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Brighter Bites

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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