Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of a Stepped-care Approach to Long-term Weight Loss
Brief Summary: The number of overweight and obese adults in the United States is increasing at a rapid rate. A "stepped-care" weight loss program, which at key times increases the frequency of contact between an individual trying to lose weight and the program staff, may be beneficial for achieving long-term weight loss. This study will compare a standard behavioral weight loss program with a "stepped-care" weight loss program in their abilities to help people who are overweight or obese to lose weight.


Options:
A: Inclusion Criteria:

* Body mass index (BMI) between 25.0 and 39.9 kg/m2

Exclusion Criteria:

* Reports losing more than 5% of current body weight in the 6 months before study entry
* Participated in a research project involving weight loss or physical activity in the 6 months before study entry
* Pregnant during the 6 months before study entry, currently breastfeeding, or planning to become pregnant in the 18 months after study entry
* Current treatment for any medical condition that could affect body weight (e.g., diabetes mellitus, cancer)
* History of heart attack or heart surgery, including bypass or angioplasty
* Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
* Currently taking medication that could affect metabolism or change body weight (e.g., synthroid)
* Currently being treated for psychological issues or has taken psychotropic medications in the 6 months before study entry
B: Inclusion Criteria:

* women aged 40-69
* overweight or Class I \& II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance
* state a commitment to losing weight
* speak and read English
* able to communicate over the telephone
* able to use a computer with minimal assistance and complete electronic forms and surveys
* have access to and are able to access the Internet
* commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention
* have or are willing to obtain an email account
* have access to a DVD player
* able to walk without an assistive device
* answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active

Exclusion Criteria:

* diagnosed with Type 1 diabetes
* diagnosed with Type 2 diabetes and require insulin
* ≥ 10% weight loss in last six months
* enrolled in a weight loss management program
* enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation
* taking medications that affect weight loss or weight gain
* other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating.
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:

1. Age 18 years or older;
2. Body mass between 30 and 55 kg/m2
3. One or more CHD risk factors: Systolic blood pressure between 130 and 200 mmHg; Diastolic blood pressure between 80 and 105 mmHg; Total cholesterol \> 180 mg/dL; LDL cholesterol \> 120 mg/dL; HDL Cholesterol \< 40 mg/dL; Triglycerides \> 150 mg/dL; HbA1c between 6.0 and 11.5%; Fasting plasma glucose between 95 and 400 mg/dL; Diagnosis of Type 2 diabetes
4. Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at Fair Oaks Adult Clinic.

Exclusion Criteria:

1. Inability to speak Spanish;
2. Unwilling to attempt weight loss;
3. Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and ongoing substance abuse;
4. On greater than 10 prescription medications;
5. Psychiatric disorders requiring antipsychotics or multiple medications;
6. Body weight change \> 25 lbs. in the preceding 3 months;
7. Pregnant, planning to become pregnant, or lactating less than six months;
8. Family household member already enrolled in the study;
9. Intends to or is enrolled in a study that would limit full participation in VAFO;
10. Participants who are unwilling to have home visits by study staff;
11. Resident of a long term care facility;
12. Plans to move during the study period (24 months post-randomization);
13. Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).

Answer: A