Please select the eligibility criteria that correspond to the clinical trial below.
Title: Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)
Brief Summary: The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.


Options:
A: Inclusion Criteria:

* Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials
* BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2
* Fasting blood glucose 95-125 mg/dl (inclusive)
* Willingness to Accept Randomization

Exclusion Criteria:

* Currently involved in a supervised program for weight loss
* Clinical history of DM, or newly diagnosed DM at screening
* Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure
* Uncontrolled high blood pressure: BP \> 160/100
* Pregnancy, breast feeding, or planning pregnancy within 2 years
* Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
* Chronic use of medicine known to significantly affect glucose metabolism, e.g., corticosteroids
* Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP PD, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), and participation in another research study that would interfere with HELP PD
B: Inclusion Criteria:

* Persons age 18 and over
* Determination of BMI ≥ 24 kg/m2; persons of Asian Descent BMI ≥ 23 kg/m2
* Completion of the 7-item ADA Diabetes Risk Assessment and an ADA risk score ≥ 5
* Persons with a value of 100mg/dl or greater will confer eligibility from a single drop of whole blood obtained by finger stick to assess casual capillary blood glucose (CCBG) concentration using One-Touch Ultra handheld glucometer.
* Persons at high-risk for Impaired Glucose Tolerance (IGT), having an ADA Risk Score ≥5 and CCBG 110-199 mg/dl or an A1c ≥5.7%and \< 6.5%.
* Women with a self-reported history of gestational diabetes with an A1c \<6.5% and/or CCBG \<199 mg/dl

Exclusion Criteria:

* Persons under the age of 18
* Persons with no evidence of pre-diabetes.
* Persons who are pregnant or planning to become pregnant.
* Person unable or unwilling to provide consent.
* Screening attendees who have a known condition that could alter glucose metabolism (e.g. pregnancy; known diabetes; antipsychotic or steroid medications; certain diseases or other conditions including Cushing's syndrome, acromegaly, pheochromocytoma, chronic pancreatitis, or HIV.)
* Heart attack, stroke or transient ischemic attack (TIA) in the past 6 months.
* Uncontrolled hypertension: systolic \> 180 mm Hg or diastolic \>105 mm Hg.
* Persons receiving treatment for cancer (excluding surgery alone) within the last 2 years(excluding skin cancer).
* Chest pain.
* Shortness of breath with minimal activity or at rest.
* Unexplained dizziness or fainting with physical activity (exercise).
* Chronic lung disease: Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen therapy (excluding sole use of a continuous positive airway pressure (CPAP) machine).
* Current use of anti-diabetes medications for the treatment of diagnosed diabetes
* Unable to communicate with research staff (including intervention staff).
* Unable to read written English.
C: Inclusion Criteria:

* Body mass index ≥ 23
* Age ≥ 35 years
* A 1st degree relative with type 2 diabetes

Exclusion Criteria:

* Normal and diabetic subjects
* Presence of other serious illness
D: 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

Answer: A