Look AHEAD Clinical Trial Launched in June 2001

A major clinical trial called Look AHEAD (Action for Health in Diabetes) was formally launched at the annual American Diabetes Association (ADA) conference on June 25, 2001 in Philadelphia. The trial will examine the long-term health effects of intensive lifestyle interventions designed to promote weight loss among overweight and obese individuals with type 2 diabetes.

"We know that losing weight has manyshort-term benefits, but we don't know whether these benefits last over many years, or if weight loss might even be harmful," said Barbara Harrison, M.S., director of obesity special projects at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and coordinator of Look AHEAD. "Look AHEAD is the largest randomized clinical trial of weight loss interventions ever undertaken. It has the potential to change the impact of obesity for individuals with type 2 diabetes and to alter medical practice and insurance payment policies for decades to come."

NIDDK along with its cosponsors, the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Nursing Research (NINR), the Centers for Disease Control and Prevention (CDC), the National Center for Minority Health and Health Disparities (NCMHD), and the Office of Research on Women's Health (ORWH), completed the design phase of Look AHEAD in March. Recruitment of approximately 5,000 volunteers, who will be followed for a period of 4 to 7 years, began in June. Study organizers hope to recruit 33 percent of the 45- to 75-year-old participants from African American, Asian American, Hispanic American, and Native American populations. Sixteen clinical sites across the country are participating in the trial.

Participants will be randomized to the Lifestyle Intervention arm or to the control arm, known as Diabetes Education and Support. The lifestyle intervention will consist of an initial diabetes education session, group meetings, individual counseling sessions, restricted caloric intake of 1,200 to 1,800 calories per day, and a physical activity program gradually increasing to 175 minutes of moderate intensity physical activity per week. After the first 6 months, weight loss medication and advanced behavioral strategies will be added to the intervention protocol for individuals who have not achieved satisfactory weight loss or who have regained lost weight. Participants enrolled in diabetes education and support will take part in the initial diabetes education session and may attend three additional education sessions and support groups per year for 4 years.

A two- to four-fold increased risk for cardiovascular disease is associated with type 2 diabetes, which in turn is strongly associated with obesity. Look AHEAD will focus on the lifestyle intervention's effect on the occurrence of cardiovascular death, non-fatal heart attack, and non-fatal stroke over a follow-up period of 11.5 years. It will also track hospitalizations and procedures used to treat these events. Study designers project that these outcomes will be reduced among those in the intervention group as compared to those in the control group. The study will also look at the intervention's impact on cardiovascular disease risk factors, diabetes control and complications, general health, quality of life, and psychological outcomes.

For more information on Look AHEAD (originally named SHOW: Study of Health Outcomes of Weight Loss), visit www.lookaheadstudy.org/index-main.html. S