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
  Purpose

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.


Condition Intervention
Diabetes
Myocardial Infarction
Stroke
Kidney Diseases
Bone Diseases
Dyslipidemia
Behavioral: Lifestyle Intervention
Behavioral: Diabetes Support and Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Look AHEAD: Action for Health in Diabetes

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • The primary outcome is the aggregate occurrence of severe cardiovascular events. [ Time Frame: 11.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5145
Study Start Date: June 2001
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
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).
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017953

Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
United States, Arizona
Southwestern American Indian Center
Phoenix, Arizona, United States, 85014
United States, California
University of Southern California
Los Angeles, California, United States, 90022
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045-0808
United States, Louisiana
Louisiana State University
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Johns Hopkins Pro-Health
Baltimore, Maryland, United States, 21207
United States, Massachusetts
Diabetes Center
Boston, Massachusetts, United States, 02114
Joslin Diabetes Center
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55415-1226
United States, New Mexico
Northern Navajo Medical Center
Shiprock, New Mexico, United States, 87420
United States, New York
Roosevelt Hospital
New York, New York, United States, 10019
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
The University of Tennessee, Memphis
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington
Seattle, Washington, United States, 98108
Sponsors and Collaborators
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mary Evans, Ph.D./Program Officer, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00017953     History of Changes
Obsolete Identifiers: NCT00000624
Other Study ID Numbers: SHOW, U01DK57136, U01DK57149, U01DK56990, U01DK57177, U01DK57171, U01DK57151, U01DK57182, U01DK57131, U01DK57002, U01DK57078, U01DK57154, U01DK57178, U01DK219, U01DK57008, U01DK57135, U01DK56992
Study First Received: June 21, 2001
Last Updated: March 15, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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:
Myocardial Infarction
Infarction
Kidney Diseases
Dyslipidemias
Diabetes Mellitus
Bone Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014