Look AHEAD: Action for Health in Diabetes

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. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave (the J point) and the beginning of the T wave)
• •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.