Look AHEAD: Action for Health in Diabetes

Stroke Clinical Trial

— LookAHEAD  

Official title:

Look AHEAD: Action for Health in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017953
• Other study ID #: BG99-042
• Secondary ID: U01DK057136U01DK
• Status: Completed
• Phase: N/A
• Start date: June 2001
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00000624

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5145
• Est. completion date: June 30, 2020
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johns — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Occurrence of a Severe Cardiovascular Event	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	First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke	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
Secondary	First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina	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
Secondary	First Occurrence of Major Clinical Events	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