Brighter Bites/Legacy Produce Rx Program

Official title

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

Overview

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

Interventions

• 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; thes
• 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.

Primary outcome measures

• Change in body mass index (BMI) [Time frame: baseline , post intervention (32 weeks after baseline)]
• Change in systolic blood pressure [Time frame: baseline , post intervention (32 weeks after baseline)]
• Change in diastolic blood pressure [Time frame: 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)]
• Change in Aspartate transaminase (AST) assessed by blood work [Time frame: 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)]
• Change in lipid panels assessed by blood work [Time frame: baseline , post intervention (32 weeks after baseline)]

Secondary outcome measures (12)

• 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)]
• 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)]
• Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener [Time frame: baseline , post intervention (32 weeks after baseline)]
• Change in amount of fruit and vegetable intake [Time frame: baseline , post intervention (32 weeks after baseline)]
• Change in amount of junk food consumed [Time frame: 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• Healthcare usage as assessed by the number of well-visits [Time frame: 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)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06407284 · HSC-SPH-23-0850

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗