期刊
CONTROLLED CLINICAL TRIALS
卷 24, 期 5, 页码 610-628出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/S0197-2456(03)00064-3
关键词
type 2 diabetes mellitus; obesity; weight loss; weight loss maintenance; CVD; behavioral interventions; lifestyle programs; physical activity; health promotion; disease prevention
资金
- NIDDK NIH HHS [U01 DK057136-09, DK56992, DK57171, U01 DK057136-10, DK57131, DK57135, DK57149, U01 DK057136-08S1, DK57177, DK57219, U01 DK057136-03S1, DK57154, DK57136, DK57008, U01 DK057136-04S1, U01 DK057136-05S1, U01 DK057136, U01 DK057136-07, DK57182, U01 DK057136-01, DK57178, U01 DK057136-09S1, DK57002, U01 DK057136-08, U01 DK057136-05, U01 DK057136-04, DK57151, U01 DK057136-02, DK57078, U01 DK057136-06, U01 DK057136-03, DK56990, U01 DK057136-04S2] Funding Source: Medline
Overweight and obesity are major contributors to both type 2 diabetes and cardiovascular disease (CVD). Moreover, individuals with type 2 diabetes who are overweight or obese are at particularly high risk for CVD morbidity and mortality. Although short-term weight loss has been shown to ameliorate obesity-related metabolic abnormalities and CVD risk factors, the long-term consequences of intentional weight loss in overweight or obese individuals with type 2 diabetes have not been adequately examined. The primary objective of the Look AHEAD clinical trial is to assess the long-term effects (up to 11.5 years) of an intensive weight loss program delivered over 4 years in overweight and obese individuals with type 2 diabetes. Approximately 5000 male and female participants who have type 2 diabetes, are 45-74 years of age, and have a body mass index greater than or equal to25 kg/m(2) will be randomized to one of the two groups. The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. This program is compared to a control condition given diabetes support and education. The primary study outcome is time to incidence of a major CVD event. The study is designed to provide a 0.90 probability of detecting an 18% difference in major CVD event rates between the two groups. Other outcomes include components of CVD risk, cost and cost-effectiveness, diabetes control and complications, hospitalizations, intervention processes, and quality of life. (C) 2003 Elsevier Inc. All rights reserved.
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