Look AHEAD: Action for Health in Diabetes (LookAHEAD)
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|ClinicalTrials.gov Identifier: NCT00017953|
Recruitment Status : Completed
First Posted : June 21, 2001
Last Update Posted : September 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Myocardial Infarction Stroke Kidney Diseases Bone Diseases Dyslipidemia||Behavioral: Lifestyle Intervention Behavioral: Diabetes Support and Education||Not Applicable|
Look AHEAD is examining, in overweight volunteers with type 2 diabetes, 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. This program will be compared to a control condition involving a program of diabetes support and education.
The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes
cardiovascular death (including fatal myocardial infarction and stroke), non-fatal myocardial infarction, hospitalized angina, and non-fatal stroke,
over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education.
Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors, diabetes control and complications, general health, and quality of life, and psychological outcomes. The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.
The Look AHEAD intensive lifestyle intervention ended September, 2012. Participants continue to be followed to determine the long-term effects of the intervention on health outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Look AHEAD: Action for Health in Diabetes|
|Actual Study Start Date :||June 2001|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||June 30, 2020|
Experimental: Lifestyle Intervention
Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss.
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.
Active Comparator: Diabetes Support and Education
The diabetes support and education arm provides group sessions on diabetes management and social support.
Behavioral: Diabetes Support and Education
Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
- Aggregate occurrence of severe cardiovascular events. [ Time Frame: up to 11 years ]Aggregate occurrence of major cardiovascular events including fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths
- Secondary aggregate events #1 [ Time Frame: up to 11 years ]Aggregate occurrence of cardiovascular deaths, myocardial infarctions (fatal or nonfatal), and strokes (fatal or non-fatal)
- Secondary aggregate events #2 [ Time Frame: up to 11 years ]Aggregate occurrence of deaths (all causes), myocardial infarctions, strokes, and hospitalizations for angina;
- Secondary aggregate events #3 [ Time Frame: up to 11 years ]Aggregate occurrence of deaths (all causes), myocardial infarctions, strokes, hospitalizations for angina, coronary artery bypass graftings, percutaneous coronary angioplasty, hospitalizations for congestive heart failure, carotid endarterectomies, or peripheral vascular procedures such as bypass or angioplasty
- Aggregate occurrence of severe cardiovascular events for up to 20 years [ Time Frame: up to 20 years ]Aggregate occurrence of major cardiovascular events including fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths
- Change in Short Form 36 (SF-36) Physical Score [ Time Frame: Baseline and annually for up to 11 years, exams 1 (16-18 years) and 2 (18-20 years) ]Scores range from 0 to 100, with a higher score representing a higher level of functioning.
- Frailty [ Time Frame: Exams 1 (16-18 years) and 2 (18-20 years) ]Frailty is assessed using the Fried criteria and is classified as non-frail, pre-frail, or frail
- End stage renal disease (ESRD) [ Time Frame: up to 20 years ]ESRD is defined as renal replacement therapy (RRT) or death from nephropathy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017953
|Principal Investigator:||Mark A Espeland, PhD||Wake Forest University Health Sciences|