Look AHEAD: Action for Health in Diabetes "Look AHEAD"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The Look AHEAD study is a multi-center, 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.

Detailed Description

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.

Conditions

Interventions

  • Lifestyle Intervention Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Lifestyle Intervention
    Description: Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss.
  • Diabetes Support and Education Behavioral
    Intervention Desc: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
    ARM 1: Kind: Experimental
    Label: Diabetes Support and Education
    Description: The diabetes support and education arm provides group sessions on diabetes management and social support.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary outcome is the aggregate occurrence of severe cardiovascular events. 11.5 years No

Sponsors