Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pregnancy and EARly Lifestyle Improvement Study
Brief Summary: The investigators propose to conduct a randomized controlled trial in 200 overweight/obese pregnant women and their offspring. The prenatal intervention will emphasize improving diet and physical activity. The lifestyle intervention will be delivered within an empowerment theoretical framework through a combination of group sessions, individual counseling, and by monitoring compliance to diet and physical activity to further tailor the intervention. The post-partum intervention sessions will include mothers and their offspring and will focus on breastfeeding, improving physical activity and quality of the diet and feeding practices through the first post-partum year. As part of routine prenatal care, participants in both the control and intervention arms will be given health-related advice. Since the majority of participants are expected to be eligible for the Women, Infants and Children (WIC) program, both groups will also receive assistance through WIC as per their routine policies. Our primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is infant BMI z-score at 12 months of age, and the investigators will also be evaluating several metabolic outcomes in mothers and infants.


Options:
A: Inclusion Criteria:

* Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.\*
* Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15 weeks 6 days based on an algorithm that compares the last menstrual period (LMP) date and data from the earliest ultrasound.\*
* BMI ≥25 kg/m2 based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study will be used. Reported pre-pregnancy weight will not be used to determine eligibility because of the potential for inaccuracy. If the earliest weight measurement is conducted at 140 to 146 weeks or 150 to 156 weeks, 1 lb or 2 lbs will be subtracted from the measured weight respectively, to adjust to a first trimester weight.\*
* Age ≥ 18\*

Exclusion Criteria:

* Diagnosis of diabetes prior to pregnancy (reported physician diagnosed diabetes other than GDM in previous pregnancy or taking insulin or medications to treat diabetes), or an HbA1c ≥ 6.5 % or other test result (elevated fasting glucose ≥126 mg/dL/7.0 mmol/L or 2 h glucose ≥200 mg/dL/11.1 mmol/L when OGTT is completed) suggestive of pre-pregnancy diabetes. All potential participants will have HbA1c performed prior to randomization.\*
* Known fetal anomaly \*
* Planned termination of pregnancy\*
* History of three or more consecutive first trimester miscarriages\*
* Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder is not an exclusion\*
* Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after discussion with the participant by study staff\*
* Actively suicidal defined as a value ≥ 2 on the BDI-II question 9\*
* Prior or planned (within 1 year of expected delivery) bariatric surgery\*
* Current use of one or more of the following medications: \*

  * Metformin
  * Systemic steroids
  * Antipsychotic agents
  * Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight
  * Medications for ADHD including amphetamines and methylphenidate
* Continued use of weight loss medication including OTC and dietary supplements for weight loss \*
* Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee Opinion #267, 2002 (reaffirmed 2009) \*

  * Hemodynamically significant heart disease defined as an AHA class II (short of breath with exercise) or greater
  * Restrictive lung disease (e.g. pulmonary fibrosis)
  * Poorly controlled seizure disorder
  * Poorly controlled hypertension (blood pressure ≥160/110)
  * History of extreme sedentary lifestyle (e.g. bed bound)
  * Orthopedic limitations to aerobic exercise
  * Severe anemia defined as a hemoglobin \< 8 g/dl or hematocrit \<24 %
* Participation in another interventional study that influences weight control\*
* Enrollment in this trial in a previous pregnancy\*
* Intention of the participant or of the care provider for the delivery to be outside the LIFE-Moms Consortium hospital\*
* Participant's unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away\*
* Past or current intravenous drug use (visual check for injection marks, recorded methadone use, self-report)
* Self-reported HIV infection (confirmed from medical records or baseline test results)
* Inability to functionally participate in group sessions and other study requirements on a regular basis during the complete duration of the study, including but not limited to the documented use of the accelerometer for the periods required by the study
* Non Spanish speaking
* Plan on giving up infant for adoption

'\*' Core eligibility criterion for the LIFE-Moms Consortium
B: Inclusion Criteria:

* Pregnant
* Gestational age at enrollment 24 - 31 weeks

Exclusion Criteria:

* Diabetes diagnosed prior to pregnancy
* Abnormal gestational diabetes (\>= 135 mg/dl) testing prior to 24 weeks' gestation
* Gestational diabetes in a previous pregnancy
* History of stillbirth or fetal death
* Pregnancy with more than one fetus
* Known major fetal anomaly
* Current or planned corticosteroid therapy
* Asthma requiring medication
* Current or planned beta adrenergic therapy
* Chronic hypertension requiring medication within 6 months of or during pregnancy
* Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
* Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
* Maternal or fetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labor, or intrauterine growth retardation
* Previous or planned tocolytic therapy to induce labor or increase contraction strength
C: Inclusion Criteria:

* non-smoking, adults,
* \< 16 weeks gestation

Exclusion Criteria:

* medical comorbidities
D: * INCLUSION CRITERIA:

Adult pregnant women of any race or ethnicity may participate if they meet each of the following inclusion criteria:

1. At least 18 years of age.
2. Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
3. Able to have an OGTT prior to 16 weeks gestation. Hyperemesis can preclude some pregnant women from successfully completing the OGTT; these women will not be excluded if the fasting blood samples can be obtained.
4. Able to have an ultrasound examination to estimate fetal age.
5. Complete initial run-in screening visits to determine whether the woman can manage the tasks required of participation in an intensive intervention if randomized to the intervention group.
6. Able to commit the time required for the interventions and follow-up.
7. Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14(0) weeks by project gestational age is acceptable. An ultrasound must be conducted before randomization that shows a fetal heartbeat; there should be no evidence of more than one fetus on the most recent pre-randomization ultrasound.
8. Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15(6) weeks based on an algorithm that compares the LMP date and data from the earliest ultrasound.
9. Body mass index greater than or equal to 25 kilogram / square meter based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study, will be used. Reported pre-pregnancy weight will not be used to determine eligibility because of the potential for inaccuracy. If the earliest weight measurement is conducted at 14(0) to 14(6) weeks or 15(0) to 15(6) weeks, 1 pound or 2 pounds will be subtracted from the measured weight, respectively, to adjust to a first trimester weight. This weight and the resultant BMI are defined as the baseline weight and BMI, respectively.

   EXCLUSION CRITERIA:
   * Diagnosis of diabetes prior to pregnancy or any of the following results of the oral glucose tolerance test at visit #1 that suggest diabetes prior to pregnancy: HbA1c greater than or equal 6.5 %, FPG greater than or equal 126 milligrams per deciliter, or 2-hour post-load plasma glucose greater than or equal 200 milligrams per deciliter (75 grams oral glucose tolerance test). All potential participants will have HbA1c and a 75 grams oral glucose tolerance test performed prior to randomization.
   * Women who meet the above criteria for diagnosed or presumed diabetes prior to pregnancy will be excluded. Others who meet criteria for GDM will be eligible. Criteria for GDM diagnosis will be based on ADA 2012 criteria (at least one of FPG greater than or equal to 92 milligrams per deciliter, 1 hour PG greater than or equal 180 milligrams per deciliter, or 2 hour PG greater than or equal to 153 milligrams per deciliter.)
   * Known fetal anomaly
   * Planned termination of pregnancy
   * History of three or more consecutive first trimester miscarriages
   * Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder (BED) is not an exclusion.
   * Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after discussion with the participant by study staff
   * Actively suicidal defined as a value greater than or equal 2 on the BDI-II question 9
   * Prior or planned (within 1 year of expected delivery) bariatric surgery
   * Current use of one or more of the following medications:

     * Metformin
     * Systemic steroids
     * Antipsychotic agents (e.g., Abilify (apriprazole), Haldol (haloperidol), Risperdal (resperidone), Seroquel (quetipapine), Zyprexa (olanzapine))
     * Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote (valproic acid), Lamictal (lamotrigine), Lithium, Neurontin (gabapentin), Tegretol (carbamazepine), Topamax (topiramate), Keppra (levetiracetam)
     * Medications for ADHD including amphetamines and methylphenidate
     * Any teratogenic agent Class D or X (site specific)
   * Continued use of weight loss medication including OTC and dietary supplements for weight loss (e.g., Adipex (phentermine), Suprenza(phentermine) Tenuate (dietheylpropion), Xenical (orlistat), Alli (orlistat), conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange)
   * Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee Opinion #267, 2002

     * Hemodynamically significant heart disease defined as an AHA class II (short of breath with exercise) or greater
     * Restrictive lung disease (e.g. pulmonary fibrosis)
     * Poorly controlled hyperthyroidism
     * Poorly controlled seizure disorder
     * Poorly controlled hypertension defined as a blood pressure greater than or equal 160/110 millimeters of mercury
     * History of extreme sedentary lifestyle (e.g. bed bound)
     * Orthopedic limitations to aerobic exercise
     * Severe anemia defined as a hemoglobin less than 8 grams per deciliter
     * Any condition that requires follow-up at specialty care clinics outside of PIMC (e.g., pregnancies at high risk for maternal or fetal demise)
   * Participation in another interventional study that influences weight control
   * Enrollment in this trial in a previous pregnancy
   * Intention of the participant or of the care provider for the delivery to be outside the greater Phoenix metropolitan area.
   * Participant s unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away.
   * Inability or unwillingness to provide informed consent, in the English language, including consent for study staff to abstract data from all prenatal and delivery records (for the current pregnancy) whether the care or delivery occur at PIMC or elsewhere. English is the common language of the participants who receive care at PIMC. Some also speak tribal languages or Spanish. English is the language used in the intervention materials, the screening forms, and online documents. English is also the primary language of study staff.
   * Any condition that in the opinion of the investigators would interfere with consent, treatment or follow-up.

Answer: A