Look AHEAD: Action for Health in Diabetes
Condition: Diabetes; Myocardial Infarction; Stroke; Kidney Diseases; Bone Diseases; Dyslipidemia
MeSH terms: Bone Diseases; Kidney Diseases; Myocardial Infarction; Diabetes Mellitus; Dyslipidemias; Infarction
Study type: Interventional

Summary: 
      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.
    

Intervention name(s): Lifestyle Intervention; Diabetes Support and Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Weight loss; Heart Attack; Heart disease; Lifestyle Intervention; Physical Fitness/Physical Activity; Psychosocial outcomes (e.g., depression, eating disorders); Bone Density