Abstract
BACKGROUND: Individuals with type 2 diabetes (T2D) experiencing food insecurity may have other non-medical, health-related social needs (e.g., transportation, housing instability) that decrease their ability to attain T2D control and impact other health outcomes. METHODS: A pragmatic randomized controlled trial (pRCT) to test the effect of produce provision, diabetes and culinary skills training and education, and social needs screening, navigation, and resolution, on hemoglobin A1c (A1c) levels in individuals with T2D (A1c ≥7.5%) experiencing food insecurity; a cost-effectiveness evaluation of the interventions that comprise the pRCT; and a process evaluation to understand the contextual factors that impact the uptake, effectiveness, and sustainability of the interventions. SETTING: Ambulatory care clinics (e.g., family medicine, general internal medicine, endocrinology) affiliated with an academic medical center in an urban environment in the Midwest. DESIGN: 2 × 2 factorial design. INTERVENTIONS: Cooking Matters for Diabetes is a 6-week diabetes and culinary education intervention. The Health Impact Ohio Central Ohio Pathways Hub intervention is a community health worker model designed to evaluate and address participants' social needs. All participants will receive referral to the Mid-Ohio Farmacy to provide weekly access to fresh produce. OUTCOMES: Primary outcome of the pRCT is change in A1c at 3 months; secondary outcomes include A1c at 6 months, and diabetes self-efficacy, food insecurity, and diet quality at 3 and 6 months. DISCUSSION: Food insecurity, unmet social needs, diabetes education and self-efficacy are critical issues that must be addressed to improve T2D treatment, care, and health equity. CLINICALTRIALS: gov: NCT05472441.