LookAHEAD: Look AHEAD: Action for Health in Diabetes

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00017953

Collaborator

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

5,145

Enrollment

Locations

Arms

229

Actual Duration (Months)

285.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Myocardial Infarction Stroke Kidney Diseases Bone Diseases Dyslipidemia	Behavioral: Lifestyle Intervention Behavioral: Diabetes Support and Education	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Look AHEAD: Action for Health in Diabetes

Actual Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Aggregate occurrence of severe cardiovascular events. [up to 11 years]
Aggregate occurrence of major cardiovascular events including fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths

Secondary Outcome Measures

Secondary aggregate events #1 [up to 11 years]
Aggregate occurrence of cardiovascular deaths, myocardial infarctions (fatal or nonfatal), and strokes (fatal or non-fatal)
Secondary aggregate events #2 [up to 11 years]
Aggregate occurrence of deaths (all causes), myocardial infarctions, strokes, and hospitalizations for angina;
Secondary aggregate events #3 [up to 11 years]
Aggregate occurrence of deaths (all causes), myocardial infarctions, strokes, hospitalizations for angina, coronary artery bypass graftings, percutaneous coronary angioplasty, hospitalizations for congestive heart failure, carotid endarterectomies, or peripheral vascular procedures such as bypass or angioplasty
Aggregate occurrence of severe cardiovascular events for up to 20 years [up to 20 years]
Aggregate occurrence of major cardiovascular events including fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths
Change in Short Form 36 (SF-36) Physical Score [Baseline and annually for up to 11 years, exams 1 (16-18 years) and 2 (18-20 years)]
Scores range from 0 to 100, with a higher score representing a higher level of functioning.
Frailty [Exams 1 (16-18 years) and 2 (18-20 years)]
Frailty is assessed using the Fried criteria and is classified as non-frail, pre-frail, or frail
End stage renal disease (ESRD) [up to 20 years]
ESRD is defined as renal replacement therapy (RRT) or death from nephropathy

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 76 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35205
2	Southwestern American Indian Center	Phoenix	Arizona	United States	85014
3	University of Southern California	Los Angeles	California	United States	90022
4	University of Colorado Health Sciences Center	Aurora	Colorado	United States	80045-0808
5	Louisiana State University	Baton Rouge	Louisiana	United States	70808
6	Johns Hopkins Pro-Health	Baltimore	Maryland	United States	21207
7	Diabetes Center	Boston	Massachusetts	United States	02114
8	Joslin Diabetes Center	Boston	Massachusetts	United States	02114
9	University of Minnesota	Minneapolis	Minnesota	United States	55415-1226
10	Northern Navajo Medical Center	Shiprock	New Mexico	United States	87420
11	Columbia University	New York	New York	United States	10019
12	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104
13	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
14	The Miriam Hospital	Providence	Rhode Island	United States	02906
15	The University of Tennessee, Memphis	Memphis	Tennessee	United States	38105
16	Baylor College of Medicine	Houston	Texas	United States	77030
17	University of Texas Health Sciences Center	San Antonio	Texas	United States	78229
18	University of Washington	Seattle	Washington	United States	98108