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:

* Age(as of date of enrollment):

  * Lower age limit: 18 years
  * Upper age limit: NONE (only exclude for cause, e.g. disease and functional limitations, as detailed below)
* Race/ethnicity: Mexican Latino of any race
* Gender: men and women
* Body mass index: ≥24 kg/m2 (≥22 kg/m2 if of Asian descent)
* Having pre-diabetes, metabolic syndrome, or both based on the following criteria:
* Pre-diabetes according to any one of the following criteria:
* Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test or by a fasting blood test during study screening
* Plasma glucose measured 2 hours after a 75 gm glucose load of 140 to 199 mg/dl if detected by a recent (within the past year), documented, blood-based diagnostic test (Oral glucose tolerance test will not be performed for study screening considering participant burden)
* Clinically diagnosed gestational diabetes mellitus during a previous pregnancy (may be self-reported)
* Metabolic syndrome according to 3 or more of the following:

  * Waist circumference ≥40 inches in men and ≥35 inches in women (≥35 inches in men and ≥31 inches in women, if of Asian descent)
  * Triglycerides \>150 mg/dL
  * High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men and \<50 mg/dL in women
  * Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg
  * Fasting plasma glucose of 100 to 125 mg/dL
* Primary Care Physician approval of patient contact for study screening
* Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of two study arms, participate in follow-up for 24 months, and authorize extraction of relevant information from the Electronic Health Record.

Exclusion criteria:

* Medical exclusions:
* Previous diagnosis of diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
* Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
* Serious medical condition anticipated to prevent person from walking 1 mile (e.g., severe pulmonary disease or aortic stenosis)
* Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
* Diagnosis of a terminal illness and/or in hospice care;
* Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
* Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
* Have had or plan to undergo bariatric surgery during the study period
* Other exclusions:
* Inability to speak, read or understand Spanish or English
* Having no reliable telephone service
* Having no regular Internet access via a computer and/or mobile device (e.g., smart-phone)
* Currently pregnant or lactating or planning to become pregnant during the study period
* Plan to move out of the area during the study period
* Family/household member of another study participant or of a study staff member
* Investigator discretion for clinical safety or protocol adherence reasons
B: 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.
C: Inclusion Criteria:

* Ages 8-16 years old
* BMI \>95th percentile for age/gender based on CDC
* Both primary caregiver/parent and child must agree to participate in the nutrition classes

Exclusion Criteria:

* endocrinopathies, including hypothyroidism and diabetes
* Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
* Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
* Any use of medication (steroids, for ex.) that contributes to excess adiposity.
* Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
* Any concurrent membership in a weight management program.
* Inability or unwillingness of parent to accompany the child to nutrition classes.
* Pregnancy
D: Inclusion Criteria:

* identified within the last 3 months with pre-diabetes which is defined as a fasting plasma glucose level of 5.6-6.9 mmol/L or a two-hour level after a 75 grams glucose load of 7.8-11 mmol/L based on the World Health Organization 1998 criteria;
* accessible by mobile phone that could receive Chinese text messages.

Exclusion Criteria:

* a history of diabetes mellitus;
* currently on medicines known to alter glucose tolerance;
* did not have a mobile phone;
* unable to read Chinese characters;
* refused to take part in current study.

Answer: B