Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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.


Options:
A: Inclusion Criteria:

* Obese
* Metabolic syndrome
* Read and write English
* Planning to stay in treatment with their PCP for the next 3 years
* On stable doses of medications for chronic diseases such as hypothyroidism for 3 years

Exclusion Criteria:

* Unstable health
* Diabetes mellitus
* Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.
B: Inclusion Criteria:

* Age 2.0 through 5.9 years receiving primary care in a multi-site group practice
* BMI \> 95th percentile for age and sex, or 85th - 95th percentile if at least one parent is overweight

Exclusion Criteria:

* Child currently enrolled in a formal weight management program
* Child is in foster care
* Chronic conditions that may limit our ability to measure height and weight or that may interfere with their growth, physical activity, or dietary recommendations
C: 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. (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.
D: Inclusion Criteria:

* Participant in the Exclusive Provider Organization (EPO), Managed Care Organization (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State Employees Group Benefits Health Insurance
* Agree to travel for treatment to the assigned study site
* Agree to randomized treatment assignment
* Male and females age 20-60 years
* Body Mass Index \>40kg/m2 but \< 60 kg/m2
* Females must be non-pregnant and using an approved contraception method
* Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless waived by Principal Investigator (PI)
* Uric Acid \<9.0 mg/dl
* Normal Creatinine
* Normal Thyroid Stimulating Hormone (TSH)
* Negative urine pregnancy test for women of childbearing potential
* Able to give written informed consent
* Able to comply with study procedures

Exclusion Criteria:

Factors that may limit adherence to interventions or affect conduct of the trial:

* Unable or unwilling to give informed consent or communicate with local study staff
* Hospitalization for psychiatric illness or substance use/abuse within the past year
* Self-report of alcohol or substance abuse within the past twelve months
* Current major depressive episode or history of suicidal behaviors
* Endorsement of significant recent suicidal ideation (as determined by PI)
* Travel plans that do not permit participation
* History of prior bariatric surgery, small bowel resection, or extensive bowel resection
* Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic medication, herbal medications for weight loss or any medication not approved by the PI.
* Another member of the household is a participant or staff member in the study
* History of eating disorder such as anorexia nervosa, bulimia, or binge eating
* Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder (as determined by the PI)
* Currently pregnant or nursing or plans to become pregnant in the next five years
* Except for non-melanoma skin cancer, cancer requiring treatment in the past five years, unless the prognosis is excellent
* Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active tuberculosis
* Cardiovascular disease event within the past year
* Severe congestive heart failure (New York Heart Association \[NYHA\] Functional Class III, IV)
* Second degree or greater heart block
* Blood Pressure \>160 systolic or \>100 diastolic on two consecutive visits, unless treated and re-screened
* Based upon responses to psychological screening or an interview, patients may be excluded by the study psychologist.
* Other medical, psychiatric, or behavioral limitations that in the judgment of the investigator may interfere with study participation or the ability to follow the intervention protocol.
* Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or oophorectomy must have a negative urine pregnancy test result at screening. Women of childbearing potential will be allowed to participate if they have undergone tubal ligation, or use one of the following types of contraception: properly used condom or diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual abstinence may constitute an acceptable birth control method for this study with investigator approval. Women with male partners who have had a successful vasectomy (more than one year of unprotected sexual intercourse without pregnancy) are not required to use additional birth control methods as long as the relationship remains exclusive, and the woman agrees to use an approved contraception method with any other male partner. Questions regarding individual patient contraceptive practices should be directed to the Principal Investigator.

Answer: C