Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
Brief Summary: The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.


Options:
A: Inclusion Criteria:

* Ethnicity: All ethnic groups;
* Body mass index 25.0-39.9 kg/m2;
* Fasting plasma glucose between 100 and 125 mg/dL;
* Any two of the following: Waist circumference \>40 inches in men, \>35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides \>150 mg/dL; High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men, \<50 mg/dL in women; Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>85 mm Hg.
* Having a primary care physician (PCP) at the PAMF Los Altos Center;
* Seen in primary or specialty care in the Palo Alto Region at least once in the preceding 24 months;
* A PAMF patient for ≥ 12 months;
* Able and willing to enroll and meet the requirements of the study.

Exclusion Criteria:

* Inability to speak, read or understand English;
* No regular access to a computer with Internet and email capabilities;
* Triglycerides \>400 mg/dL;
* Systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg;
* Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months
* Having a medical (e.g., celiac disease) or social condition (e.g., religious beliefs) that precludes dietary changes;
* Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe;
* Use of weight-loss medications in the past 3 months;
* Regular use (\> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
* Currently enrolled in a lifestyle intervention program at PAMF or elsewhere;
* Planning to undergo a bariatric surgery during the study period;
* Diagnosis of Type 1 or Type 2 diabetes mellitus;
* Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse;
* Renal insufficiency (i.e., GFR \< 60 mL/min/1.73m2)
* Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
* Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
* Diagnosis of a terminal illness and/or in hospice care;
* Pregnant, lactating or planning to become pregnant during the study period;
* Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;
* Family/household member of another study participant or of a study staff member;
* No longer a PAMF patient or planning to transfer care outside of PAMF during the study period;
* Planning to move out of the area during the study period;
* PCP determination that the study is inappropriate or unsafe for the patient;
* Investigator discretion for clinical safety or protocol adherence reasons.
B: Inclusion Criteria:

* 18+
* High risk of developing type 2 diabetes as identified through a risk score

Exclusion Criteria:

* Diagnosed diabetes
* Taking steroid medication
* Serious chronic illness preventing participation in trial
* Unable to speak English
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: Participation as a volunteer in the Diabetes Prevention Program (DPP).

Answer: A