While trials such as the Diabetes Prevention Program have demonstrated a significant potential for the prevention of type 2 diabetes mellitus (DM) through lifestyle interventions, a critical knowledge gap is whether such approaches can be implemented in the community. Our goal is to translate DM prevention research into community practice via key translations that have been pilot-tested to enhance logistical and fiscal feasibility and dissemination including 1) finding prediabetes cases based on adiposity and fasting glucose, 2) the use of a group-based lifestyle intervention employing professional and lay health counselors (LHCs) aided by standardized informational videos and other tools, and 3) delivery of the intervention in the community setting via innovative expansion of an existing diabetes education program collaborating with LHCs as empowered community partners. We propose a 480-participant randomized trial to test the hypothesis that a lifestyle intervention administered through a community-based diabetes prevention program will have a beneficial and clinically meaningful impact on: fasting glucose (primary outcome), physical activity, dietary intake, weight, and waist circumference (secondary outcomes), and other tertiary outcomes. An economic evaluation will be conducted to determine cost effectiveness. One trial arm will consist of a group-based intensive lifestyle intervention promoting healthy eating, increased physical activity and modest, yet achievable (5-7%) weight loss delivered in an early 6-month intensive phase followed by an 18-month maintenance phase. LHCs will be utilized in the intensive intervention arm. The control arm will consist of an individual educational intervention that incorporates existing community resources that are available to assist residents in making healthier lifestyle choices. We have revised our plan based on the reviewers' comments and the results of our pilot work. We have described our organizational plan in greater detail and increased our resource allocation for training, monitoring and supporting the LHCs in their roles. We have developed drafts of intervention tools, including videos, that will enhance standardization of intervention delivery and subsequent dissemination. We have piloted our proposed methods of LHC recruitment and training, and participant recruitment, assessment and early intervention. We have improved the description of our analytic plan. We are confident we can conduct this important translational project. If the intensive intervention approach is cost-effective, this model could be disseminated to the thousands of U.S. communities with diabetes education programs. ? Many chronic diseases are influenced by activity and diet. Our lifestyle intervention, if successful, should translate into public health benefits in areas other than type 2 DM, such as obesity, hypertension, cardiovascular health and cancer prevention, thus greatly multiplying the potential benefits for society. ? ?
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