Clinical trial

Brighter Bites/Legacy Produce Rx Program

Opening soon · Not applicable · 1 countries · Registry ID NCT06407284

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionChild Obesity

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Change in body mass index (BMI)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.

Change in systolic blood pressurebaseline , post intervention (32 weeks after baseline)

Change in diastolic blood pressurebaseline , post intervention (32 weeks after baseline)

Change in hemoglobin A1c as assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in Aspartate transaminase (AST) assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in Alanine transaminase (ALT) assessed by blood workbaseline , post intervention (32 weeks after baseline)

Change in lipid panels assessed by blood workbaseline , post intervention (32 weeks after baseline)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The University of Texas Health Science Center at Houston🇺🇸 Houston, Texas, United States

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Ru-Jye Chuang, DrPH, M.S.Contact

Email · Call 713-500-9244

Mallika MathurContact