Look AHEAD: Action for Health in Diabetes

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.

Conditions

• Diabetes
• Myocardial Infarction
• Stroke
• Kidney Diseases
• Bone Diseases
• Dyslipidemia

Interventions

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.

BEHAVIORAL

Diabetes Support and Education

Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Nursing Research (NINR)

  collaborator NIH

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Office of Research on Women's Health (ORWH)

  collaborator NIH

• Centers for Disease Control and Prevention

  collaborator FED

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Mark A Espeland, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

76 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-06-30

Primary Completion

2012-09-30

Completion

2020-06-30

Countries

• United States

Study Locations