Look AHEAD: Action for Health in Diabetes (Look AHEAD)
Number of Subjects in Study Archive: 5145
Study Design: Clinical Trial
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, Obesity
Duration: 2001 – Present
# Recruitment Centers: 16
Treatment: Behavioral Weight Loss Intervention
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00017953
Short-term studies have shown numerous benefits of weight loss in overweight or obese patients, including improvements in glycemic control, risk factors for cardiovascular disease, quality of life, and other obesity-related coexisting illnesses. The Look AHEAD study was designed to test whether weight loss similarly improved cardiovascular morbidity and mortality in patients with type 2 diabetes. The study is a multicenter, randomized clinical trial that examines the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity.
Eligible patients with type 2 diabetes and a body-mass index (BMI) of 25.0 or more were enrolled and randomly assigned either to participate in an intensive lifestyle intervention (intervention group) or to receive diabetes support and education (control group). The intensive lifestyle intervention, which included both group and individual counseling sessions, was aimed at achieving and maintaining weight loss of at least 7% by focusing on reduced caloric intake and increased physical activity. The diabetes support and education program featured sessions focusing on diet, exercise, and social support. Both the intervention and control programs occurred with decreasing frequency as the trial progressed. The primary outcome measure is the first occurrence of a composite cardiovascular outcome, which consists of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for angina. Participants will be followed for a planned period of 13.5 years.
The Look AHEAD intensive lifestyle intervention ended in September, 2012. Participants continued to be followed to determine the long-term effects of the intervention on health outcomes.
The current data package contains data through the end of the intervention program.
The primary objective of the Look AHEAD study was to test whether an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity improves the long-term cardiovascular morbidity and mortality of overweight patients with type 2 diabetes.
The primary outcome measure is the first occurrence of a composite cardiovascular outcome, which consists of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke, and hospitalization for angina. Participants will be followed for a planned period of 13.5 years.
There are three composite secondary outcome measures, which include: (1) death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; (2) death from any cause, myocardial infarction, stroke, or hospitalization for angina; and (3) death from any cause, myocardial infarction, stroke, hospitalization for angina, coronary-artery bypass grafting, percutaneous coronary intervention, hospitalization for heart failure, or peripheral vascular disease.
Key additional outcomes include cognitive and physical function, metabolic biomarkers, medication usage, and healthcare utilization.
Participants between 45 and 75 years of age who met the following criteria were eligible for the study:
- Self-reported type 2 diabetes, as verified by the use of glucose-lowering medication, a physician's report, or glucose levels
- A body-mass index ≥ 25.0 ( ≥ 27.0 in patients taking insulin)
- A glycated hemoglobin level ≤ 11%
- A systolic blood pressure < 160 mm Hg; a diastolic blood pressure < 100 mm Hg
- A triglyceride level < 600 mg/deciliter
- The ability to complete a valid maximal exercise test, suggesting it was safe to exercise
- An established relationship with a primary care provider
Exclusion criteria are documented in the study protocol.
Initial results showed that the intensive lifestyle intervention, as compared with diabetes support and education, did not reduce the risk of cardiovascular morbidity and mortality among overweight or obese patients with type 2 diabetes. While no significant differences in the primary outcome were found between the two groups, patients in the intervention group did show clinically meaningful improvements in glycated hemoglobin levels, which were greatest during the first year but were at least partly sustained throughout follow-up. This positive effect may explain why patients in the intervention group were less likely to be treated with insulin during this period. Furthermore, patients in the intervention group were more likely to have a partial remission of diabetes during the first 4 years of the trial than were those in the control group. Participants continue to be followed to determine the long-term effects of the intervention on a variety of health outcomes.