Look AHEAD: Action for Health in Diabetes

Completed · Not applicable

Conditions studied: Diabetes, Myocardial Infarction, Stroke, Kidney Diseases, Bone Diseases, Dyslipidemia

In brief

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.

Key facts

Study ID

NCT00017953

Run by

Wake Forest University Health Sciences

People needed

5145

Starts

2001-06-01

Expected to finish

2020-06-30

Last updated by the study team

2023-08-02

Who can join

Age: 55 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Southwestern American Indian Center — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Louisiana State University — Baton Rouge, Louisiana, United States
• Johns Hopkins Pro-Health — Baltimore, Maryland, United States
• Diabetes Center — Boston, Massachusetts, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Northern Navajo Medical Center — Shiprock, New Mexico, United States
• Columbia University — New York, New York, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• The University of Tennessee, Memphis — Memphis, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Sciences Center — San Antonio, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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