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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.
 
ClinicalTrials.gov Identifier: NCT00017953
Recruitment Status : Completed
First Posted : June 21, 2001
Last Update Posted : September 30, 2022
Sponsor:
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
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Study Design
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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
Actual Study Completion Date : June 30, 2020
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. Secondary aggregate events #2 [ Time Frame: up to 11 years ]
    Aggregate occurrence of deaths (all causes), myocardial infarctions, strokes, and hospitalizations for angina;

  3. 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

  4. 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

  5. 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.

  6. 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

  7. End stage renal disease (ESRD) [ Time Frame: up to 20 years ]
    ESRD is defined as renal replacement therapy (RRT) or death from nephropathy


Eligibility Criteria
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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
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT00017953


Locations
Show Show 18 study locations
Sponsors and Collaborators
Wake Forest University Health Sciences
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
Investigators
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Principal Investigator: Mark A Espeland, PhD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] May 3, 2018

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov 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: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00017953    
Obsolete Identifiers: NCT00000624
Other Study ID Numbers: BG99-042
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Within one year of each phase of the study
URL: https://repository.niddk.nih.gov/studies/look-ahead/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Diabetes
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
Dyslipidemias
Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lipid Metabolism Disorders
Musculoskeletal Diseases