Look AHEAD: Action for Health in Diabetes (LookAHEAD)
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|ClinicalTrials.gov Identifier: NCT00017953|
Recruitment Status : Completed
First Posted : June 21, 2001
Last Update Posted : September 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Myocardial Infarction Stroke Kidney Diseases Bone Diseases Dyslipidemia||Behavioral: Lifestyle Intervention Behavioral: Diabetes Support and Education||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||5145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Look AHEAD: Action for Health in Diabetes|
|Actual Study Start Date :||June 2001|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||June 30, 2020|
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.
- Aggregate occurrence of severe cardiovascular events. [ Time Frame: 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 aggregate events #1 [ Time Frame: up to 11 years ]Aggregate occurrence of cardiovascular deaths, myocardial infarctions (fatal or nonfatal), and strokes (fatal or non-fatal)
- Secondary aggregate events #2 [ Time Frame: up to 11 years ]Aggregate occurrence of deaths (all causes), myocardial infarctions, strokes, and hospitalizations for angina;
- Secondary aggregate events #3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: up to 20 years ]ESRD is defined as renal replacement therapy (RRT) or death from nephropathy
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|Ages Eligible for Study:||55 Years to 76 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Type 2 diabetes
- 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
- 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.
- Amputation of lower limbs as result of non-traumatic causes.
- Any major organ transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017953
|Principal Investigator:||Mark A Espeland, PhD||Wake Forest University Health Sciences|
Documents provided by Wake Forest University Health Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
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 )
|First Posted:||June 21, 2001 Key Record Dates|
|Last Update Posted:||September 30, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||We plan to share data sets through the NIDDK repository, baseline data sets are currently available. Outcome data will be available approximately 1 year after the study is over.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Within one year of each phase of the study|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Physical Fitness/Physical Activity
Psychosocial outcomes (e.g., depression, eating disorders)
Glucose Metabolism Disorders
Endocrine System Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Lipid Metabolism Disorders