Home Food Delivery for Diabetes Management in Patients of Rural Clinics

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ABSTRACT Approximately 30 million (~9%) of all people in the US have type 2 diabetes (T2DM),1 and this number is expected to continue to rise.2 At the same time, 15 million (11.8%) US households experience food insecurity,3 defined as lack of access to adequate amounts of healthy food. T2DM and food insecurity are strongly related for U.S. adults: Very low food security is associated with an over 100% increase in T2DM prevalence compared with adults from high food-secure households.4 Residents of rural areas are particularly threatened by the intersection of food insecurity and T2DM. Food insecurity prevalence in rural areas is 1.2 times higher than in metropolitan areas.6 T2DM prevalence in rural areas is 17% higher than in metropolitan areas.7 Recent studies have shown promise for improving health indicators for food insecure people with T2DM. These studies have tested interventions distributing healthy food and shown preliminary indications of success for improving glycemic control, diabetes distress, self-reported diabetes management, and food security.22-24,29 We will test this approach for the first time in rural areas in a way that both promotes participant adherence and is scalable: we will employ home-delivery of T2DM-appropriate food boxes with evidence based-educational materials and recipes to improve glycemic control and diet quality of rural food insecure patients with T2DM. This intervention adopts a health equity framework:30,31 it addresses specific needs and barriers of rural food insecure households at risk for many health and economic disparities. Our long-term goal is to transform rural residents' management of T2DM.This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. Our specific aims are: 1. Compare the effectiveness of the Healthy Food Delivery Intervention (HFDI) plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM. 2. Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM. 3. Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone. We will conduct a fully-powered, comparative effectiveness RCT that includes 400 food insecure patients with T2DM. These patients will be recruited from clinics serving rural populations. Patients will be randomly assigned to either the HFDI plus standard care or standard care alone, with 200 in each arm. Baseline and follow up data (post-intervention, six months post- intervention, and 12 months post-intervention) will be collected from patients in both study arms. The Healthy Food Delivery intervention (HFDI) outcomes and findings will be applicable to vulnerable rural populations. This proposal directly addresses NIH funding priorities related to food insecurity.32