OBJECTIVE-Look AHEAD (Action for Health in Diabetes) Study is a 16-center randomized clinical trial in overweight and obese individuals with type 2 diabetes designed to evaluate the longterm effects (up to 11.5 years) of an intensive weight loss intervention on the time to incidence for major cardiovascular events.RESEARCH DESIGN AND METHODS-Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals age 45-74 years, BMI >25 kg/ m 2 (>27 kg/m 2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomized to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education.
RESULTS-The 5145 participants who were randomized between 2001 and 2004 were 63.3 % white, 15.6% African-American, 13.2% Hispanic, 5.1% American Indian, and 1.0% AsianAmerican, which closely paralleled the ethnic distribution of diabetes in the NHANES 1999-2000 survey. Their average age at entry was 59 ± 6.8 years (mean ± SD), and 60% were women. There were 31.5% between 45-54 years of age, 51.5% were 55-64, and 17.0% ≥65 years of age. There were 14.6% of participants who were taking insulin at the time of randomization and 14.1 % had a history of cardiovascular disease. More men (21.2%) than women (9.3%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36 ± 5.9 kg/m 2 at baseline with 83.6% of the men and 86.0% of women having a BMI >30 kg/m 2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/ m 2 .
CONCLUSIONS-TheLook AHEAD study has successfully randomized a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background.
IntroductionLook AHEAD is a randomized clinical trial being conducted in 16 centers in the U.S. The purpose of the Look AHEAD trial is to determine whether cardiovascular morbidity and mortality in persons with type 2 diabetes can be reduced through an intensive lifestyle intervention aimed at producing and maintaining weight loss. Briefly the intensive lifestyle intervention includes moderate-intensity physical activity to achieve and sustain at least 200 min per week of exercise together with a healthy diet that includes portion-controlled foods (3). The goal of this intervention is for individuals to achieve and maintain at least 10% loss Address Correspondence to: Mark Espeland, PhD, Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, 27157.
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