Named Look AHEAD (Action for Health in Diabetes), the multicenter,
randomized clinical trial will examine the effects of a lifestyle intervention program
designed to promote weight loss through reduced calorie intake and regular
exercise in approximately 5,000 volunteers. Look AHEAD will examine how the
lifestyle interventions affect heart attack, stroke and cardiovascular-related death in
people with type 2 diabetes the disease most affected by overweight and
obesity. This program will be compared to a program involving diabetes support
“More than 16 million Americans have diabetes, with some 800,000 new cases
diagnosed each year. If these dangerous trends continue, the impact on our
nation’s health and medical care costs in future years will be overwhelming,” said
Health and Human Services Secretary Tommy G. Thompson. “This study offers an
important opportunity to gain additional insight into effective ways to prevent or
reduce the health burden of diabetes.”
People who are between 45 and 75 years of age, have type 2 diabetes and are
classified as overweight or obese (as defined by the study protocol) are eligible.
The study seeks equal numbers of men and women and expects that 33 percent of
the participants will come from ethnic minority groups. People who meet these
criteria and who wish to participate in the study should call (866) 55AHEAD
(552-4323) or visit www.LookAHEADstudy.org, the study web site.
Those who qualify for Look AHEAD will be assigned at random to either its
Lifestyle Program or its Diabetes Support and Education Program. The Lifestyle
Program is an intensive diet and exercise program designed to help participants
lose at least 7 to 10 percent of their initial weight in the first year of the study.
Participants will be expected to adopt a program of regular exercise, primarily
walking, with a goal of 25 minutes per day. Instead of the lifestyle program, a
comparison group will be enrolled in the Diabetes Support and Education
Program. They will attend sessions on nutrition and physical activity and may
attend support groups with other people who have diabetes.
Individuals will be followed for up to 11.5 years. During this period, researchers
will track cardiovascular risk factors, diabetes control, the development of
complications, and general health and quality of life.
“We have an enormous opportunity to learn more about the role long-term weight
loss can play in improving the health of overweight individuals with type 2
diabetes,” said Rena R.Wing, Ph.D., co-chair of Look AHEAD. “We know
short-term weight loss can benefit overweight people with diabetes; we just don’t
have good data about the long-term effects.”
More than 50 percent of adults in America are considered overweight. The
percent of obese Americans has risen from 16 to 22 percent in the past 15 years.
Although the reasons are not well understood, overweight affects minorities
Type 2 diabetes has reached epidemic proportions in the United States, largely
due to the number of Americans who are overweight or obese. According to the
American Diabetes Association, the incidence of diabetes among middle-aged
people 40 to 74 years of age increased 38 percent between 1976 and 1994.
Today, 80 percent of people with type 2 diabetes are overweight or obese. In
addition, type 2 diabetes is associated with a two- to fourfold risk of coronary
artery disease. Heart attacks and strokes are the leading causes of death in people
with type 2 diabetes.
“Obesity in America is a serious risk factor for a number of diseases and
conditions, diabetes especially,” said F. Xavier Pi-Sunyer, M.D., co-chair of Look
AHEAD. “This study will help us understand the effects of weight loss on diabetes
and many other disorders.”
Short-term weight loss has been shown to have beneficial effects on diabetes and
cardiovascular disease. To date, there have been no randomized trials on the
benefits of long-term weight loss because of the difficulty of achieving and
maintaining weight loss. The study has a budget of more than $180 million.
Wing is professor of psychiatry and human behavior at Brown Medical
School/Miriam Hospital, and director of their Weight Control and Diabetes
Research Center. She also maintains an appointment as professor of psychiatry,
psychology and epidemiology at the University of Pittsburgh. She serves on the
National Task Force on Prevention and Treatment of Obesity (under the
NIDDK), and is an NIDDK Advisory Council member. Pi-Sunyer is director of
the Obesity Research Center at St. Luke’s-Roosevelt Hospital Center in New
York, and director of the NIDDK-funded New York Obesity and Nutrition
Other federal sponsors of Look AHEAD include the National Heart, Lung and
Blood Institute; the National Institute of Nursing Research; the National Center for
Minority Health and Health Disparities; the Office of Research on Women’s
Health; all of the NIH, and the Centers for Disease Control and Prevention.