Look AHEAD: Action for Health in Diabetes (LookAHEAD)

July 13, 2023 updated by: Wake Forest University Health Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • The University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Southwestern American Indian Center
    • California
      • Los Angeles, California, United States, 90022
        • University of Southern California
    • Colorado
      • Aurora, Colorado, United States, 80045-0808
        • University of Colorado Health Sciences Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • Johns Hopkins Pro-Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Diabetes Center
      • Boston, Massachusetts, United States, 02114
        • Joslin Diabetes Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415-1226
        • University of Minnesota
    • New Mexico
      • Shiprock, New Mexico, United States, 87420
        • Northern Navajo Medical Center
    • New York
      • New York, New York, United States, 10019
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • The University of Tennessee, Memphis
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Sciences Center
    • Washington
      • Seattle, Washington, United States, 98108
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Overweight
  • BMI of 25 kg/m2 or greater
  • If on insulin, BMI of 27 kg/m2 or greater
  • Blood pressure less than 160/100 mmHg
  • HbA1c less or equal to 11%
  • Triglycerides less than 600 mg/dl
  • Willingness to participate

Exclusion Criteria:

  • Unable or unwilling to give informed consent or communicate with local study staff.
  • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
  • Hospitalization for depression in past six months.
  • Self-report of alcohol or substance abuse within the past twelve months.
  • Current consumption of more than 14 alcoholic drinks per week.
  • Current acute treatment or rehabilitation program for these problems.
  • Plans to relocate to an area not served by Look AHEAD or travel plans that do not permit full participation in the study.
  • Lack of support from primary care health provider or family members.
  • Failure to complete the two-week run-in for dietary intake and exercise.
  • Weight loss exceeding 10 lbs. in past three months.
  • Current use of medications for weight loss.
  • Self reported inability to walk two blocks.
  • History of bariatric surgery, small bowel resection, or extensive bowel resection.
  • Chronic treatment with systemic corticosteroids.
  • Another member of the household is a participant or staff member in Look AHEAD.
  • Currently pregnant or nursing.
  • Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured.
  • HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV.
  • Active tuberculosis (self-report).
  • Cardiovascular disease (heart attack or procedure within the past three months).
  • Participation in a cardiac rehabilitation program within last three months.
  • Stroke or history/treatment for transient ischemic attacks in the past three months.
  • Pulmonary embolus in past six months.
  • Unstable angina pectoris or angina pectoris at rest.
  • A history of cardiac arrest.
  • Complex ventricular arrhythmia at rest or with exercise (e.g., ventricular tachycardia).
  • Uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more).
  • New York Heart Association (NYHA) Class III or IV congestive heart failure.
  • Acute myocarditis, pericarditis or hypertrophic myocardiopathy.
  • Clinically significant aortic stenosis.
  • Left bundle branch block or cardiac pacemaker unless evaluated and cleared for participation by a cardiologist.
  • Cardiac defibrillator.
  • Heart transplant.
  • History of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair.
  • Resting heart rate less than 45 beats per minute or greater than 100 beats per minute.
  • Any abnormality during the maximum exercise stress test that indicates that it would be unsafe to participate in the Lifestyle Intervention.
  • Angina pectoris.
  • Significant ST segment depression at low levels of exercise. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave (the J point) and the beginning of the T wave)
  • Exercise induced ventricular arrhythmias.
  • Abnormal hemodynamics, such as flat or decreasing systolic blood pressure with increasing workload.
  • Those at moderate to high risk for cardiac complications during exercise.
  • Those who are unable to self-regulate activity or understand the recommended activity level.
  • Renal disease or dialysis.
  • Chronic obstructive pulmonary disease that would limit ability to follow the protocol.
  • Self-reported chronic hepatitis B or C or cirrhosis.
  • Inflammatory bowel disease requiring treatment in past year.
  • Cushing's syndrome.
  • Acromegaly.
  • Amputation of lower limbs as result of non-traumatic causes.
  • Any major organ transplant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Occurrence of a Severe Cardiovascular Event
Time Frame: up to 11 years
Number of participants with first on-study occurrence of one of the following major cardiovascular events: fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths
up to 11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke
Time Frame: up to 11 years
Number of participants with first occurrence of one of the following: cardiovascular death, myocardial infarction (fatal or nonfatal), or stroke (fatal or non-fatal)
up to 11 years
First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina
Time Frame: up to 11 years
Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, or hospitalizations for angina
up to 11 years
First Occurrence of Major Clinical Events
Time Frame: up to 11 years
Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, hospitalization for angina, coronary artery bypass grafting, percutaneous coronary angioplasty, hospitalization for congestive heart failure, carotid endarterectomy, or peripheral vascular procedures such as bypass or angioplasty
up to 11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
Centers for Disease Control and Prevention
Office of Research on Women's Health (ORWH)

Investigators

  • Principal Investigator: Mark A Espeland, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2001

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 21, 2001

First Submitted That Met QC Criteria

June 20, 2001

First Posted (Estimated)

June 21, 2001

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BG99-042
  • U01DK057136 (U.S. NIH Grant/Contract)
  • U01DK057149 (U.S. NIH Grant/Contract)
  • U01DK056990 (U.S. NIH Grant/Contract)
  • U01DK057177 (U.S. NIH Grant/Contract)
  • U01DK057171 (U.S. NIH Grant/Contract)
  • U01DK057151 (U.S. NIH Grant/Contract)
  • U01DK057182 (U.S. NIH Grant/Contract)
  • U01DK057131 (U.S. NIH Grant/Contract)
  • U01DK057002 (U.S. NIH Grant/Contract)
  • U01DK057078 (U.S. NIH Grant/Contract)
  • U01DK057154 (U.S. NIH Grant/Contract)
  • U01DK057178 (U.S. NIH Grant/Contract)
  • U01DK057219 (U.S. NIH Grant/Contract)
  • U01DK057008 (U.S. NIH Grant/Contract)
  • U01DK057135 (U.S. NIH Grant/Contract)
  • U01DK056992 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share data sets through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) repository, baseline data sets are currently available. Outcome data will be available approximately 1 year after the study is over.

IPD Sharing Time Frame

Within one year of each phase of the study

IPD Sharing Access Criteria

Publicly available / De-identified

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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