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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Heart, Lung, and Blood Institute (NHLBI) National Institute of Nursing Research (NINR) National Center on Minority Health and Health Disparities (NCMHD) Office of Research on Women's Health (ORWH) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00017953 |
The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.
Condition | Intervention |
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Diabetes Myocardial Infarction Stroke Kidney Diseases Bone Diseases Dyslipidemia |
Behavioral: Lifestyle Intervention Behavioral: Diabetes Support and Education |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Look AHEAD: Action for Health in Diabetes |
Estimated Enrollment: | 5145 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lifestyle Intervention: Experimental
Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss.
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Behavioral: Lifestyle Intervention
The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.
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Diabetes Support and Education: Active Comparator
The diabetes support and education arm provides group sessions on diabetes management and social support.
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Behavioral: Diabetes Support and Education
Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
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Research has shown that weight loss has many short-term benefits, such as improvements in blood pressure, but we do not know if attempts to lose weight over the long term are beneficial. Some studies even suggest that losing weight may lead to health problems such as gall bladder disease and bone loss. Look AHEAD will help us understand the long-term effects of weight loss on health, and see if it helps reduce heart attacks and strokes.
We hope to learn the long-term benefits and risks of a program designed to achieve and maintain weight loss. The study will consist of two groups of volunteers. One group will be asked to eat fewer calories and increase their physical activity. This group will be compared to a second group who will receive diabetes support and education. Both groups will receive medical monitoring. In addition to heart attacks and stroke, Look AHEAD will study the effects of the interventions on other factors relating to heart disease, on diabetes control and complications, and on relative costs and quality of life associated with the interventions. Overall, this study will help doctors in the future in advising their patients who have diabetes about losing weight.
About 5,000 men and women in 19 cities around the country will take part in the study. The study will last 9 to 11.5 years: the length of time will depend on when the individual starts the study.
Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
The University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35205 | |
United States, Arizona | |
Southwestern American Indian Center | |
Phoenix, Arizona, United States, 85014 | |
United States, California | |
University of Southern California | |
Los Angeles, California, United States, 90022 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80045-0808 | |
United States, Louisiana | |
Louisiana State University | |
Baton Rouge, Louisiana, United States, 70808 | |
United States, Maryland | |
Johns Hopkins Pro-Health | |
Baltimore, Maryland, United States, 21207 | |
United States, Massachusetts | |
Diabetes Center | |
Boston, Massachusetts, United States, 02114 | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55415-1226 | |
United States, New Mexico | |
Northern Navajo Medical Center | |
Shiprock, New Mexico, United States, 87420 | |
United States, New York | |
Roosevelt Hospital | |
New York, New York, United States, 10019 | |
United States, Pennsylvania | |
University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
The Miriam Hospital | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
The University of Tennessee, Memphis | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
University of Texas Health Sciences Center | |
San Antonio, Texas, United States, 78229 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98108 |
Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ( Mary Evans, Ph.D./Program Officer ) |
Study ID Numbers: | SHOW, U01DK57136, U01DK57149, U01DK56990, U01DK57177, U01DK57171, U01DK57151, U01DK57182, U01DK57131, U01DK57002, U01DK57078, U01DK57154, U01DK57178, U01DK219, U01DK57008, U01DK57135, U01DK56992 |
Study First Received: | June 21, 2001 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00017953 |
Health Authority: | United States: Federal Government |
Diabetes Weight loss Heart Attack Heart disease |
Lifestyle Intervention Physical Fitness/Physical Activity Psychosocial outcomes (e.g., depression, eating disorders) Bone Density |
Cerebral Infarction Myocardial Ischemia Benzocaine Bone Diseases Body Weight Necrosis Musculoskeletal Diseases Urologic Diseases Weight Loss Kidney Diseases Myocardial Infarction Dyslipidemias Eating Disorders Depression |
Heart Diseases Metabolic Diseases Stroke Diabetes Mellitus Vascular Diseases Endocrine System Diseases Ischemia Depressive Disorder Endocrinopathy Infarction Glucose Metabolism Disorders Metabolic disorder Lipid Metabolism Disorders |
Pathologic Processes Cardiovascular Diseases |