Addressing Cost Barriers to Healthy Eating with Eat Well, a Prescription Produce Subsidy, for Patients with Diabetes and at Risk for Food Insecurity: Study Protocol for a Type 1 Hybrid Effectiveness-Implementation Pragmatic Randomized Controlled Trial

Background: Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management strategies are needed to improve food security in realworld health system settings. We seek to test the effect of a prescription produce program, 'Eat Well' on cardiometabolic health and healthcare utilization. We will also assess the implementation of an automated, affirmative outreach strategy. Methods: We will recruit approximately 2400 patients from an integrated academic health system in the southeastern United States as part of a two-arm parallel hybrid type 1 pragmatic randomized controlled trial. Patients with diabetes, at risk for food insecurity, and a recent hemoglobin A1c reading will be eligible to participate. The intervention arm receives, 'Eat Well', which provides a debit card with $80 (added monthly) for 12 months valid for fresh, frozen, or canned fruits and vegetables across grocery retailers. The control arm does not. Both arms receive educational resources with diabetes nutrition and self-management materials, and information on existing care management resources. Using an intent-to-treat analysis, primary outcomes include hemoglobin A1C levels and emergency department visits in the 12 months following enrollment. Reach and fidelity data will be collected to assess implementation. Discussion: Addressing food insecurity, particularly among those at heightened cardiometabolic risk, is critical to equitable and effective population health management. Pragmatic trials provide important insights into the effectiveness and implementation of 'Eat Well' and approaches like it in real-world settings. Registration: ClinicalTrials.gov Identifier: NCT05896644; Clinical Trial Registration Date: 2023-06-09.