Improving diabetes health is a public-health imperative. Type II diabetes mellitus (T2DM) is highly prevalent and a leading cause of disability and cardiovascular disease in the US. T2DM disproportionately impacts low-income individuals in the US, who are also at significant risk for food insecurity, defined as having limited access to nutritious food for a healthy life. Food insecurity is associated with poor diabetes control, morbidity, and mortality. Diabetes self-management education, such as that provided via the evidence-based Diabetes Self-Management Program (DSMP), is an important aspect of diabetes care but does not address structural barriers to diabetes health, such as lack of access to healthy foods to follow a diabetes diet. Medically-tailored, diabetes-healthy food support may improve nutrition, self-management, mental health and diabetes health for low-income individuals with T2DM based on preliminary studies. Yet the efficacy of this approach on diabetes health may vary depending on the design of food support, how it is integrated with diabetes education, and how it is situated vis- -vis healthcare. Generating rigorous evidence to inform the design and implementation of medically-tailored food interventions for diabetes is crucial, given the current policy interest in addressing the twin issues of food insecurity and chronic illness via ?food as medicine? approaches. Together with The Health Trust, a non-profit organization with extensive experience providing the DSMP and nutrition services to low-income, chronically-ill individuals in Northern California, we propose the Nutrition-Enhanced Wellness DSMP (NEW-DSMP) Pilot Study. Our goal for this pragmatic, pilot cluster-randomized trial is to test the feasibility, acceptability and preliminary impact of providing 12 weeks of diabetes-healthy food support (i.e. medically-tailored meals and groceries), plus individualized sessions with a registered dietitian, to low-income individuals with T2DM participating in the DSMP, compared to DSMP participation alone. Participants will be eligible if they have T2DM, are over 21, are low-income, and speak English or Spanish.
In Aim 1, we will conduct three focus groups to investigate preferences, challenges, and opportunities for intervention design and implementation.
In Aim 2, we will pilot the NEW-DSMP intervention for feasibility, acceptability and preliminary impact using a cluster- randomized design. We will randomize 6 DSMP groups (~12 people per group) 1:1 to intervention and control arms (total individual n=72), following them over four assessments at 0, 6, 12 and 24 weeks with surveys, anthropometry, and blood samples. Our primary outcome is glycemic control, measured via hemoglobin A1c; secondary outcomes include fasting glucose and health-related quality-of-life. We will also test the impact on intermediate nutritional, mental health, and behavioral outcomes.
In Aim 3, we will conduct process evaluation to understand intervention and trial strengths and weaknesses. Data from this pilot study will inform the planning of a full-size cluster-randomized trial to test the efficacy of the NEW-DSMP model, with a long-term goal to inform policy debates about the value of implementing medically-tailored food interventions as part of healthcare.
Significance A multicomponent intervention combining formal diabetes self-management support with medically-tailored food and registered-dietitian support is a novel and potentially effective strategy to improve diabetes health and quality-of-life, and reduce diabetes disparities, among low-income people with type II diabetes mellitus (T2DM). Our team will conduct a pilot cluster-randomized trial in a real-world setting among low-income individuals with T2DM enrolled in a Diabetes Self-Management Program (DSMP) to understand whether enhancing the DSMP with diabetes-healthy, medically-tailored food provision and registered-dietitian support is feasible, acceptable and preliminarily improves diabetes health. Study results will inform the planning of a subsequent efficacy trial, with the goal to inform the integration of diabetes care programs with food security systems, to improve diabetes health outcomes and reduce socioeconomic disparities.