LOOK AHEAD: ACTION FOR HEALTH IN DIABETES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: The primary objective of the Look AHEAD project is to examine, in overweight volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. RESEARCH PLAN: This program is compared to a controlled condition involving a program of diabetes support and education. The primary basis for the comparison is the incidence of serious cardiovascular events. Other outcomes, including cardiovascular disease risk factors, diabetes related metabolic factors and complications, and the cost-effectiveness of the intensive intervention are also studied. Study population will be approximately 5,000 volunteers with type 2 diabetes who are 45-75 years old and overweight (body mass index greater than or equal to 25). METHODS: Eligible volunteers are randomly assigned to an intensive lifestyle intervention or to diabetes support and education. Treatment assignments are unmasked. The lifestyle intervention is implemented with individual supervised and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. The primary outcome is the aggregate occurrence of severe cardiovascular events including fatal and non-fatal myocardial infarctions, stroke, and cardiovascular deaths over a planned follow-up period of up to 11.5 years. The study is a multi-center, two-armed randomized, controlled clinical trial. With 5,000, the study has a 90% probability of detecting an 18% difference in major cardiovascular disease events between the intervention groups.