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NCT Number: NCT06390397

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

The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes 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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This study is active but is not currently recruiting participants.

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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

  • Must be a patient at University of Texas Physicians Greens Clinic or University of Texas Physicians Pediatric Primary Care in Houston, Texas
  • BMI>85th percentile
  • 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
  • a family member/sibling currently participating in Brighter Bites
  • child is currently attending a school that offers Brighter Bites

Treatment and study plan

Produce prescription program

Other

Boxes of fresh fruit 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. Participants 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.

Standard of care

Other

Standard of care includes routine lab work collection and weight and diet counseling for overweight or obese children. Additionally, referrals placed to community resources for those identified with Social Determinants of Health(SDOH) needs.

Primary outcomes

  1. Change in body mass index (BMI)

    Time frame: baseline , post intervention (32 weeks after baseline)

  2. Change in systolic blood pressure

    Time frame: baseline , post intervention (32 weeks after baseline)

  3. Change in diastolic blood pressure

    Time frame: baseline , post intervention (32 weeks after baseline)

  4. Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

  5. Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

  6. Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

  7. Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

  8. Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

  9. Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

  10. Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work

    Time frame: baseline , post intervention (32 weeks after baseline)

Secondary outcomes

  1. Change in amount of fruit and vegetable intake

    Time frame: baseline , post intervention (32 weeks after baseline)

  2. Change in amount of junk food consumed

    Time frame: baseline , post intervention (32 weeks after baseline)

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

    Time frame: baseline , post intervention (32 weeks after baseline)

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

    Time frame: baseline , post intervention (32 weeks 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 , post intervention (32 weeks 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 , post intervention (32 weeks after baseline)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Brighter Bites and Humana Foundation

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2024
Registry last updated
Jul 8, 2025

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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