Overview

This trial is active, not recruiting.

Conditions diabetes, myocardial infarction, stroke, kidney diseases, bone diseases, dyslipidemia
Treatments lifestyle intervention, diabetes support and education
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date June 2001
End date January 2021
Trial size 5145 participants
Trial identifier NCT00017953, NCT00000624, SHOW, U01DK056990, U01DK056992, U01DK057002, U01DK057008, U01DK057078, U01DK057131, U01DK057135, U01DK057136, U01DK057149, U01DK057151, U01DK057154, U01DK057171, U01DK057177, U01DK057178, U01DK057182, U01DK057219

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss.
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)
The diabetes support and education arm provides group sessions on diabetes management and social support.
diabetes support and education
Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.

Primary Outcomes

Measure
The primary outcome is the aggregate occurrence of severe cardiovascular events.
time frame: 11.5 years

Secondary Outcomes

Measure
Change in lifespan
time frame: 11 years
Change in health care costs
time frame: 11 years
change in frailty
time frame: 11 years
change in diabetic microvascular complications
time frame: 11 years
change in quality of life
time frame: 11 years

Eligibility Criteria

Male or female participants from 55 years up to 76 years old.

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). - 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. - 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.

Additional Information

Official title Look AHEAD: Action for Health in Diabetes
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).