Design and protocol of a clinic-based comparative effectiveness randomized controlled trial to determine the feasibility and effectiveness of food prescription program strategies in at-risk pediatric populations

BACKGROUND: Produce prescription programs are gaining traction in the U.S.; however, data on the impact of such approaches in pediatric populations are limited. The purpose of our clinic-based comparative effectiveness randomized controlled trial (CE RCT) is to evaluate the preliminary effectiveness of two produce prescription strategies (at-home delivery and grocery store vouchers) implemented by the Brighter Bites non-profit organization in improving obesity-related health outcomes and dietary behaviors among low-income 5-12-year-olds in Houston, Texas. This paper presents the study design, intervention components, and the study measures. METHODS: Participants (n = 150) are being recruited from two pediatric clinics in Houston, Texas. Child eligibility criteria are aged 5-12 years, Medicaid recipients, body-mass index (BMI) percentile ≥85 and living within 10 miles of a Brighter Bites distribution site. Following consent and baseline measures, children are randomized into one of three arms: (1) Bi-weekly $25 vouchers redeemable for produce at stores (n = 50), (2) Bi-weekly produce delivery to participants' homes through DoorDash (n = 50), and (3) wait-list usual care controls (n = 50). Intervention participants also receive Brighter Bites nutrition education materials. Main child outcome measures are BMI z-scores, blood pressure, hemoglobin A1c, liver panels, and lipid panels. Other outcomes including household food insecurity, child diet quality, and home nutrition environment will be collected through parent surveys. Outcome measures are collected at baseline and post-intervention. Process evaluation will measure program dosage, reach, acceptability, and feasibility. CONCLUSIONS: Our paper presents the design and next steps to ensure the successful implementation of a produce prescription program in a pediatric clinic setting.