Look AHEAD: Action for Health in Diabetes - Tabular View

Tracking Information
First Received Date ^ICMJE	June 21, 2001
Last Updated Date	July 22, 2008
Start Date ^ICMJE	June 2001
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 22, 2008)	The primary outcome is the aggregate occurrence of severe cardiovascular events. [ Time Frame: 11.5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00017953 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 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.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Diabetes Myocardial Infarction Stroke Kidney Diseases Bone Diseases Dyslipidemia
Intervention ^ICMJE	Behavioral: Lifestyle Intervention Behavioral: Diabetes Support and Education
Study Arms / Comparison Groups	Experimental: Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Active Comparator: The diabetes support and education arm provides group sessions on diabetes management and social support.
Publications *	Williamson DA, Rejeski J, Lang W, Van Dorsten B, Fabricatore AN, Toledo K; Look AHEAD Research Group. Impact of a weight management program on health-related quality of life in overweight adults with type 2 diabetes. Arch Intern Med. 2009 Jan 26;169(2):163-71. Gorin AA, Niemeier HM, Hogan P, Coday M, Davis C, DiLillo VG, Gluck ME, Wadden TA, West DS, Williamson D, Yanovski SZ; Look AHEAD Research Group. Binge eating and weight loss outcomes in overweight and obese individuals with type 2 diabetes: results from the Look AHEAD trial. Arch Gen Psychiatry. 2008 Dec;65(12):1447-55. Espeland MA, Regensteiner JG, Jaramillo SA, Gregg E, Knowler WC, Wagenknecht LE, Bahnson J, Haffner S, Hill J, Hiatt WR; Look AHEAD Study Group. Measurement characteristics of the ankle-brachial index: results from the Action for Health in Diabetes study. Vasc Med. 2008 Aug;13(3):225-33. Raynor HA, Jeffery RW, Ruggiero AM, Clark JM, Delahanty LM; Look AHEAD (Action for Health in Diabetes) Research Group. Weight loss strategies associated with BMI in overweight adults with type 2 diabetes at entry into the Look AHEAD (Action for Health in Diabetes) trial. Diabetes Care. 2008 Jul;31(7):1299-304. Epub 2008 Mar 28. Ribisl PM, Lang W, Jaramillo SA, Jakicic JM, Stewart KJ, Bahnson J, Bright R, Curtis JF, Crow RS, Soberman JE; Look AHEAD Research Group. Exercise capacity and cardiovascular/metabolic characteristics of overweight and obese individuals with type 2 diabetes: the Look AHEAD clinical trial. Diabetes Care. 2007 Oct;30(10):2679-84. Epub 2007 Jul 20.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	5145
Completion Date	December 2012
Estimated Primary Completion Date	December 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). 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.
Gender	Both
Ages	55 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00017953
Responsible Party	Mary Evans, Ph.D./Program Officer, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID Numbers ^ICMJE	SHOW, U01DK57136, U01DK57149, U01DK56990, U01DK57177, U01DK57171, U01DK57151, U01DK57182, U01DK57131, U01DK57002, U01DK57078, U01DK57154, U01DK57178, U01DK219, U01DK57008, U01DK57135, U01DK56992
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE	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)
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP