Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevenção do Diabetes em Mulheres Com Diabetes Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil
Brief Summary: Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes.


Options:
A: Inclusion Criteria:

* Women aged 18 or older having gestational diabetes, regardless of the diagnostic criteria, who used insulin during their pregnancy or were found to have impaired glucose tolerance or impaired fasting glucose (\>=100 mg/dL) on a post-partum oral glucose tolerance test (OGTT).
* We amended the protocol to also include women using oral hypoglycemics during pregnancy because their use increased during the trial implementation.

Exclusion Criteria:

* Confirmed postpartum diabetes (two abnormal OGTTs) or current use of antidiabetic medication
* Indication that the trial interventions will not be feasible, for example, distance from the trial site
* Poor attendance/response in previous contacts (appointments or phone interviews)
* Health limitations or treatments (assessed by questionnaire) restricting the nutritional intervention or the ability to practice physical activity, affecting glucose tolerance or limiting participation or survival.
B: Inclusion Criteria:

* Live in or near Chennai, India
* Aged 20-65 years
* A BMI \>22 kg/m2 and/or a waist circumference \>90 cm for men and \>80 cm for women
* No prior diabetes diagnosis, except for gestational diabetes
* At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
* Willingness to consent to randomization

Exclusion Criteria:

* Does not fulfill inclusion criteria
* Currently pregnant or breastfeeding
* History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.
C: 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
D: 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

Answer: A