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Look AHEAD: Action for Health in Diabetes (LookAHEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017953
Recruitment Status : Unknown
Verified March 2018 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2001
Last Update Posted : March 8, 2018
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2001
Actual Primary Completion Date : September 2012
Estimated Study Completion Date : January 2020

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.

Primary Outcome Measures :
  1. The primary outcome is the aggregate occurrence of severe cardiovascular events. [ Time Frame: 11.5 years ]

Secondary Outcome Measures :
  1. Change in lifespan [ Time Frame: 11 years ]
  2. Change in health care costs [ Time Frame: 11 years ]
  3. change in frailty [ Time Frame: 11 years ]
  4. change in diabetic microvascular complications [ Time Frame: 11 years ]
  5. change in quality of life [ Time Frame: 11 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00017953

Show Show 18 study locations
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Centers for Disease Control and Prevention
Publications automatically indexed to this study by Identifier (NCT Number):
Look AHEAD Research Group, Gregg EW, Jakicic JM, Blackburn G, Bloomquist P, Bray GA, Clark JM, Coday M, Curtis JM, Egan C, Evans M, Foreyt J, Foster G, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jeffery RW, Johnson KC, Kitabchi AE, Knowler WC, Kriska A, Lang W, Lewis CE, Montez MG, Nathan DM, Neiberg RH, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Redmon B, Regensteiner J, Rejeski J, Ribisl PM, Safford M, Stewart K, Trence D, Wadden TA, Wing RR, Yanovski SZ. Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial. Lancet Diabetes Endocrinol. 2016 Nov;4(11):913-921. doi: 10.1016/S2213-8587(16)30162-0. Epub 2016 Aug 30.

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00017953    
Obsolete Identifiers: NCT00000624
Other Study ID Numbers: SHOW
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: March 8, 2018
Last Verified: March 2018
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.
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Weight loss
Heart Attack
Heart disease
Lifestyle Intervention
Physical Fitness/Physical Activity
Psychosocial outcomes (e.g., depression, eating disorders)
Bone Density
Additional relevant MeSH terms:
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Bone Diseases
Kidney Diseases
Myocardial Infarction
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lipid Metabolism Disorders
Musculoskeletal Diseases