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Look AHEAD: Action for Health in Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00017953
First received: June 21, 2001
Last updated: March 15, 2011
Last verified: March 2011

June 21, 2001
March 15, 2011
June 2001
December 2014   (final data collection date for primary outcome measure)
The primary outcome is the aggregate occurrence of severe cardiovascular events. [ Time Frame: 11.5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00017953 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Look AHEAD: Action for Health in Diabetes
Look AHEAD: Action for Health in Diabetes

The Look AHEAD study is a multicenter, 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.

Research has shown that weight loss has many short-term benefits, such as improvements in blood pressure, but we do not know if attempts to lose weight over the long term are beneficial. Some studies even suggest that losing weight may lead to health problems such as gall bladder disease and bone loss. Look AHEAD will help us understand the long-term effects of weight loss on health, and see if it helps reduce heart attacks and strokes.

We hope to learn the long-term benefits and risks of a program designed to achieve and maintain weight loss. The study will consist of two groups of volunteers. One group will be asked to eat fewer calories and increase their physical activity. This group will be compared to a second group who will receive diabetes support and education. Both groups will receive medical monitoring. In addition to heart attacks and stroke, Look AHEAD will study the effects of the interventions on other factors relating to heart disease, on diabetes control and complications, and on relative costs and quality of life associated with the interventions. Overall, this study will help doctors in the future in advising their patients who have diabetes about losing weight.

About 5,000 men and women in 19 cities around the country will take part in the study. The study will last 9 to 11.5 years: the length of time will depend on when the individual starts the study.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Myocardial Infarction
  • Stroke
  • Kidney Diseases
  • Bone Diseases
  • Dyslipidemia
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5145
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017953
SHOW, U01DK57136, U01DK57149, U01DK56990, U01DK57177, U01DK57171, U01DK57151, U01DK57182, U01DK57131, U01DK57002, U01DK57078, U01DK57154, U01DK57178, U01DK219, U01DK57008, U01DK57135, U01DK56992
Yes
Mary Evans, Ph.D./Program Officer, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Nursing Research (NINR)
  • National Center on Minority Health and Health Disparities (NCMHD)
  • Office of Research on Women's Health (ORWH)
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2011

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