CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,145 enrolled
Drug / intervention
Lifestyle Intervention +1 morebehavioral
Likely dose
Lifestyle intervention with goal of ≥7% weight loss and 175 minutes/week physical activity over 4 years; diabetes support and education 3 sessions/yearAI-extracted
Key inclusion· 7
  • Type 2 diabetes mellitus
  • Overweight with BMI ≥25 kg/m² (≥27 kg/m² if on insulin)
  • Blood pressure <160/100 mmHg
  • HbA1c ≤11%
Key exclusion· 29
  • Schizophrenia, other psychotic disorders, or bipolar disorder
  • Hospitalization for depression in past 6 months
  • Alcohol or substance abuse within past 12 months or >14 alcoholic drinks per week
  • Cardiovascular event (heart attack or procedure) within past 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00017953
NCT00017953N/ACompleted

Look AHEAD: Action for Health in Diabetes

Wake Forest University Health Sciences·interventional·Posted Jun 21, 2001·Updated Aug 2, 2023

In Brief

A clinical study evaluating Lifestyle Intervention and Diabetes Support and Education for Diabetes and 5 related conditions. Completed, enrolled 5,145 participants across 18 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2001
Enrollment StartJun 1, 2001
Primary CompletionSep 1, 2012
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 25.0 years ago

Interventions

Lifestyle Interventionbehavioral

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.

Diabetes Support and Educationbehavioral

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