Real-World Interventions for Type 2 Diabetes Prevention (REALITY): A Multisite Study to Assess the Effectiveness and Cost-Effectiveness of the National Diabetes Prevention Program

Introduction The National Diabetes Prevention Program was created on the basis of evidence from landmark clinical trials. Its format was modified to facilitate real-world delivery. The long-term effectiveness and cost-effectiveness of the National Diabetes Prevention Program and similar lifestyle change programs in real-world settings remain largely unknown. The Centers for Disease Control and Prevention issued a request for proposals to establish and fund a research network to determine the long-term effectiveness of the National Diabetes Prevention Program in reducing Type 2 diabetes incidence, improving cardiovascular disease risk factors and health-related quality of life, and reducing healthcare service utilization and costs. Methods Researchers at the University of California Los Angeles, Northwestern University, the University of Michigan, and Emory University, with a coordinating center at RTI International, were funded to examine incident Type 2 diabetes and cardiovascular disease risk factors among a diverse group of National Diabetes Prevention Program and MOVE! enrollees and nonenrollees using electronic health record and administrative claims data. The network will also assess health utility scores by conducting a health-related quality of life survey; examine healthcare utilization, costs, and cost-effectiveness of the National Diabetes Prevention Program and MOVE! for diabetes prevention; and assess the costs of delivering these programs. Results The study sites have collaborated with RTI and Centers for Disease Control and Prevention to develop common core data elements and standardized study procedures to ensure that each site collects data that can be harmonized across sites. Conclusions The results of this research will address the objectives of Healthy People 2030 ; help define the longer-term real-world effectiveness of the National Diabetes Prevention Program; and guide the resources needed to provide and improve program accessibility, sustainability, and effectiveness and improve population-level outcomes.