Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes

• Published in: Controlled clinical trials 2003-10, Vol.24 (5), p.610-628
• Main Authors: Ryan, Donna H, Espeland, Mark A, Foster, Gary D, Haffner, Steven M, Hubbard, Van S, Johnson, Karen C, Kahn, Steven E, Knowler, William C, Yanovski, Susan Z
• Format: Article
• Language: English
• Subjects: Aged; Behavioral interventions; Cardiovascular Diseases - etiology; Cardiovascular Diseases - prevention & control; CVD; Diabetes Mellitus, Type 2 - complications; Disease prevention; Health promotion; Humans; Lifestyle programs; Middle Aged; Monitoring, Physiologic; Obesity; Obesity - complications; Patient Education as Topic; Patient Selection; Physical activity; Randomized Controlled Trials as Topic - methods; Research Design; Risk Reduction Behavior; Type 2 diabetes mellitus; Weight loss; Weight Loss - physiology; Weight loss maintenance
• ISSN: 0197-2456; 1879-050X
• DOI: 10.1016/S0197-2456(03)00064-3

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 ⩾25 kg/m2 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.