Look AHEAD (Action for Health in Diabetes) is a multi-center, randomized clinical trial investigating the effects of an intensive lifestyle intervention program. It will evaluate the effect of reduced caloric intake and increased physical activity on the incidence of major cardiovascular events such as heart attack, stroke, and cardiovascular-related death.
At study entry, 5,145 participants at 16 centers across the United States were randomly assigned to one of two interventions. Those in a so-called "intensive lifestyle intervention group" met regularly with a lifestyle counselor in a combination of group and individual sessions. They were given specific caloric consumption and exercise goals, were encouraged to maintain a diet and exercise diary, and were taught behavioral skills such as problem solving and goal setting. After the first year, participants were seen individually at least once monthly, had at least one additional phone or email contact each month, and were invited to attend additional group classes. Those in the "diabetes support and education group" were invited to group sessions each year focused on diet, physical activity, or social support. They were not weighed at these sessions or counseled on behavioral strategies.
At the time of enrollment, participants were between 45 and 76 years of age. Most were obese with a mean body mass index (BMI) of 36. BMI is a measure of weight in relation to height. A BMI of 18.5 to 24.9 is considered healthy, a BMI of 25 to 29.9 is overweight, and 30 or more is obese. Thirty-seven percent of participants were from racial and ethnic minority groups, and approximately 60 percent were women. Over 94 percent of participants remain involved after four years and will continue to be followed for up to 13.5 years.
Over the first four years of Look AHEAD, participants in both groups showed positive changes in their health. On average, across all four years, participants in the intensive lifestyle group lost significantly more weight than participants in the support and education group. On average, members of the lifestyle group lost 6.2 percent of their initial body weight, and members of the support and education group lost 0.9 percent of their initial body weight. The intensive intervention group also experienced greater improvements in fitness, diabetes control, blood pressure, HDL (good) cholesterol, and triglycerides. The diabetes support group showed larger reductions in LDL (bad) cholesterol, a change associated with the increased use of cholesterol-lowering medications. The study results do not break down results by demographic groups such as gender, age, race or ethnicity.
"This important study shows that lifestyle changes have long-term favorable effects on diabetes control and cardiovascular disease risk factors in overweight or obese individuals with type 2 diabetes," said Griffin P. Rodgers, M.D., director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the primary sponsor of the study.
"It is important to note that participants in the intensive lifestyle group and the diabetes education and support group have had positive changes in their weight and their cardiovascular risk factors over the four years," said study chair Rena Wing, Ph.D., of the Miriam Hospital/the Warren Alpert Medical School of Brown University in Providence, R.I.
Longer-term follow-up of Look AHEAD participants will determine whether improvements in risk factors including blood pressure, lipids and glucose control can be sustained -- independently and as a consequence of continued weight loss -- and whether the intensive lifestyle intervention is effective in reducing the incidence of illness and death due to cardiovascular disease. These results will not be available for several years. Other important study objectives include understanding the impact of weight loss and improved fitness on diabetes complications, general health, quality of life, and psychological outcomes. Researchers also will evaluate the cost and cost-effectiveness of the intensive lifestyle intervention compared to diabetes support and education.
###Overweight and obesity affect more than 60 percent of adult Americans -- a rate that has been increasing rapidly. Obesity is associated with a number of significant conditions including diabetes and cardiovascular disease. For more information about obesity and weight control, visit NIDDK's Weight-Control Information Network, .
About 24 million people in the United States have diabetes, diagnosed or undiagnosed. It is the main cause of kidney failure, limb amputations, new onset blindness in adults and a major cause of heart disease and stroke. The longer a person has diabetes, the greater the chances of developing serious damage to the eyes, nerves, heart, kidneys, and blood vessels.
Type 2 diabetes, which accounts for up to 95 percent of all diabetes cases, becomes more common with increasing age. The disease is strongly associated with overweight and obesity, inactivity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, and racial or ethnic background. The prevalence of diagnosed diabetes has more than doubled in the last 30 years, due in large part to the upsurge in obesity. Learn more about diabetes at and from the National Diabetes Education Program at .
Find more information about the Look AHEAD trial (NCT00017953) at www.lookaheadtrial.org. For a list of centers enrolling patients for diabetes or obesity trials, search for keywords "diabetes" or "obesity" at .
In addition to NIDDK and CDC, other sponsors include the National Heart, Lung, and Blood Institute, National Institute of Nursing Research, and the Office of Research on Women´s Health -- all at the NIH. The trial was designed collaboratively by the investigators of the 16 Clinical Centers, the Coordinating Center, the NIH and the CDC.
NIDDK, a part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit .
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .
EDITOR'S NOTE: Institutions currently participating in Look AHEAD are: Wake Forest University Baptist Medical Center, Winston-Salem, N.C. (Coordinating Center); the Johns Hopkins Medical Institutions, Baltimore; Pennington Biomedical Research Center, Baton Rouge, La.; University of Alabama-Birmingham; Harvard Center: Massachusetts General Hospital, Joslin Diabetes Center and Beth Israel Deaconess Medical Center, Boston; University of Colorado Health Sciences Center, Denver; Baylor College of Medicine, Houston; University of Tennessee Health Sciences Center, Memphis, Tenn.; University of Minnesota, Minneapolis; St. Luke's-Roosevelt Hospital Center, New York City; University of Pennsylvania, Philadelphia; University of Pittsburgh; The Miriam Hospital/The Warren Alpert Medical School of Brown University, Providence, R.I.; University of Texas Health Science Center at San Antonio; VA Puget Sound Health Care System/University of Washington, Seattle; Southwestern American Indian Center, Phoenix and Shiprock, N.M.; and University of Southern California, Los Angeles.
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