Brighter Bites/Legacy Produce Rx Program

NCT ID: NCT06407284

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Child Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Produce Prescription Group

Group Type EXPERIMENTAL

Produce Prescription Group

Intervention Type OTHER

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.

Control Group

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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USDA The Gus Schumacher Nutrition Incentive Program (GusNIP)

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Ru-Jye Chuang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru-Jye Chuang, DrPH, M.S.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Ru-Jye Chuang, DrPH, M.S.

Role: CONTACT

713-500-9244

Mallika Mathur

Role: CONTACT

Facility Contacts

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Ru-Jye Chuang, DrPH, M.S.

Role: primary

713-500-9244

Mallika Mathur

Role: backup

Other Identifiers

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HSC-SPH-23-0850

Identifier Type: -

Identifier Source: org_study_id

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