Brighter Bites/Legacy Produce Rx Program

NCT06407284 | Not Yet Recruiting

• 1 other identifier: HSC-SPH-23-0850
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Child Obesity

Outcome Measures

Primary Outcomes (7)

• Change in body mass index (BMI)

  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

  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

  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

  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

  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

  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

  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 Outcomes (13)

• Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool

  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

  baseline , post intervention (32 weeks after baseline)

• Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener

  baseline , post intervention (32 weeks after baseline)

• Change in amount of fruit and vegetable intake

  baseline , post intervention (32 weeks after baseline)

• Change in amount of junk food consumed

  baseline , post intervention (32 weeks after baseline)

Study Arms (2)

Produce Prescription Group

EXPERIMENTAL

Other: Produce Prescription Group

Control Group

ACTIVE COMPARATOR

Other: Control Group

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.

Produce Prescription Group

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.

Control Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• USDA The Gus Schumacher Nutrition Incentive Program (GusNIP): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ru-Jye Chuang, DrPH, M.S.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Jye Chuang, DrPH, M.S.

CONTACT

713-500-9244; Ru-Jye.Chuang@uth.tmc.edu

Mallika Mathur

CONTACT

Mallika.Mathur@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)