Brighter Bites/Legacy Produce Rx Program

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06407284
Status
Not Yet Recruiting

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Conditions

  • Child Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Produce Prescription Group — 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 — 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.

Study Details

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

Key Dates

Start date
Jan 15, 2025
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Produce Prescription Group
  • Active Comparator: Control Group

Primary Outcome Measure

Change in body mass index (BMI) [ Time Frame: baseline , post intervention (32 weeks after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Ru-Jye Chuang, DrPH, M.S.
[email protected]
713-500-9244
Mallika Mathur
[email protected]

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