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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 : February 22, 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

Tracking Information
First Submitted Date  ICMJE June 21, 2001
First Posted Date  ICMJE June 21, 2001
Last Update Posted Date February 22, 2022
Actual Study Start Date  ICMJE June 2001
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2021)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Look AHEAD: Action for Health in Diabetes
Official Title  ICMJE Look AHEAD: Action for Health in Diabetes
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Myocardial Infarction
  • Stroke
  • Kidney Diseases
  • Bone Diseases
  • Dyslipidemia
Intervention  ICMJE
  • 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.
  • Behavioral: Diabetes Support and Education
    Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
Study Arms  ICMJE
  • Experimental: Lifestyle Intervention
    Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss.
    Intervention: Behavioral: Lifestyle Intervention
  • Active Comparator: Diabetes Support and Education
    The diabetes support and education arm provides group sessions on diabetes management and social support.
    Intervention: Behavioral: Diabetes Support and Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2008)
5145
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
5000
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00017953
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Within one year of each phase of the study
URL: https://repository.niddk.nih.gov/studies/look-ahead/
Current Responsible Party Wake Forest University Health Sciences
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Wake Forest University Health Sciences
Original Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Mark A Espeland, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP