Brighter Bites/Legacy Produce Rx Program

January 8, 2025 updated by: Ru-Jye Chuang, The University of Texas Health Science Center, Houston

Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription

The purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas
  • BMI greater than or equal to 85th percentile
  • reside within a 10-mile radius of Houston Food Bank
  • Medicaid recipients or low-income uninsured
  • parents must be able to read and write in English or Spanish to complete surveys
  • patient and parents must confirm their willingness to complete the participant's well-child visit for the entire period of the study (approximately one year).

Exclusion Criteria:

  • currently participating in Brighter Bites
  • with a family member/sibling currently participating in Brighter Bites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Other: Control Group
Participants in this group will be selected from de-identified Electronic Health Record (EHR) provided by Legacy Community Health with a 1-to-1 match to the intervention group participant's demographic characteristics and Medicaid eligibility.
Experimental: Produce Prescription Group
Other: Produce Prescription Group
Participants will receive 16 produce bags, each containing approximately 50 servings of F&V. The produce bags will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F&V bags will be distributed to families every 2 weeks for 16 distributions (over approximately 32 weeks). Participants will also receive nutrition education, including MyPlate.gov's Start Simple App for adolescents, and a Virtual Culinary Medicine Program for parents; these nutrition education programs are theory-driven, tailored to diverse populations, and proven to support behavior change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI)
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)
Change in systolic blood pressure
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)
Change in diastolic blood pressure
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)
Change in hemoglobin A1c as assessed by blood work
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)
Change in Aspartate transaminase (AST) assessed by blood work
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)
Change in Alanine transaminase (ALT) assessed by blood work
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)
Change in lipid panels assessed by blood work
Time Frame: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
baseline , post intervention (32 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in amount of fruit and vegetable intake
Time Frame: baseline , post intervention (32 weeks after baseline)
baseline , post intervention (32 weeks after baseline)
Change in amount of junk food consumed
Time Frame: baseline , post intervention (32 weeks after baseline)
baseline , post intervention (32 weeks after baseline)
Change in number of times subject eats out at restaurants
Time Frame: baseline , post intervention (32 weeks after baseline)
baseline , post intervention (32 weeks after baseline)
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)
baseline , post intervention (32 weeks after baseline)
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)
baseline , post intervention (32 weeks after baseline)
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)
baseline , post intervention (32 weeks after baseline)
Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool
Time Frame: baseline , post intervention (32 weeks after baseline)
This is a 2 item questionnaire and each is categorically scored as often true, sometimes true or never true, higher number indicating higher prevalence of household food insecurity
baseline , post intervention (32 weeks after baseline)
Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service
Time Frame: baseline , post intervention (32 weeks after baseline)
This is a 6 item questionnaire and raw scores range from 0-6, higher score indicating worse outcome
baseline , post intervention (32 weeks after baseline)
Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener
Time Frame: baseline , post intervention (32 weeks after baseline)
This is a 4 item questionnaire, each is scored from 0-4, higher score indicating better outcome
baseline , post intervention (32 weeks after baseline)
Change in impact of the Produce Prescription intervention on adolescent patients' behavioral and emotional health as assessed by the Patient Health Questionnaire for Adolescents (PHQ-A)
Time Frame: baseline , post intervention (32 weeks after baseline)
This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 27, higher score indicating worse outcome
baseline , post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of well-visits
Time Frame: post intervention (32 weeks after baseline)
post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of visits due to illness
Time Frame: post intervention (32 weeks after baseline)
post intervention (32 weeks after baseline)
Healthcare usage as assessed by the number of no shows to clinic appointments
Time Frame: From 6 months prior to the intervention to two months post-intervention
From 6 months prior to the intervention to two months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)

Investigators

  • Principal Investigator: Ru-Jye Chuang, DrPH, M.S., The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-23-0850

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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