Look AHEAD: Action for Health in Diabetes (LookAHEAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00017953|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2001
Last Update Posted : March 8, 2018
|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|
|Estimated Study Completion Date :||January 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.
- The primary outcome is the aggregate occurrence of severe cardiovascular events. [ Time Frame: 11.5 years ]
- Change in lifespan [ Time Frame: 11 years ]
- Change in health care costs [ Time Frame: 11 years ]
- change in frailty [ Time Frame: 11 years ]
- change in diabetic microvascular complications [ Time Frame: 11 years ]
- change in quality of life [ Time Frame: 11 years ]
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