Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Gestational Diabetes Through Lifestyle Modification (RADIEL) - a Randomized Controlled Multi-centre Intervention Study
Brief Summary: OVERALL OBJECTIVES:

1. To assess the efficacy of a diet and exercise intervention before and/or during pregnancy in the prevention of GDM and its fetal complications in women with high diabetes risk.
2. To assess the cost-effectiveness of a diet and exercise intervention in the prevention of GDM from a socio-economic point of view. To find out whether the intervention can be used to reduce health care costs due to GDM and T2DM.
3. To determine the long-term effectiveness of the above-mentioned lifestyle intervention in the reduction of T2DM incidence among women with prior GDM and their offspring

STUDY SUBJECTS Group 1: Women planning pregnancy with a history of diet/insulin-treated GDM or BMI \>30 kg/m2. N= 250 + 250.

Group 2: Women in early pregnancy with a history of diet/insulin-treated GDM or BMI \>30 kg/m2. N= 250 + 250

METHOD The Finnish multi-center randomized controlled intervention trial started in the maternity hospitals of Helsinki and Uusimaa District Area 1/2008 and in the South-Karelia Central Hospital in Lappeenranta in 9/2008. 1000 women at high GDM risk will be recruited. Half of the subjects are randomized into the intervention group and the other half act as controls receiving only standard antenatal care in addition to the laboratory tests taken and questionnaires administered by the RADIEL study.

The active intervention arm of the study will be carried out in a structured, standardized manner by diabetes nurses and nutritionists specifically trained for their tasks. The intervention includes:

1. Structured visits to diabetes nurse every 3 months before and during pregnancy as well as at 6 weeks, 6 and 12 months post partum. Visits include e.g. structured counseling on diet and exercise, setting of specific goals, follow-up of achievements, laboratory tests and measurements
2. Structured group visits to nutritionist at the moment of enrollment in the study, at the beginning of pregnancy as well as at 6 and 12 months post partum. Additional individual visits are booked if needed.
3. Services of physical activity advisors are provided by the study subjects' cities of residence free of charge to all who wish to receive extra counseling on exercise. If exercise goals are not met, study subjects book an appointment with the physical activity advisor.

LIFESTYLE TARGETS: 1.Weight: A weight loss of 5-10% before pregnancy if BMI \> 25 and/or limited weight gain during the first two trimesters in pregnancy if BMI \> 30. 2.Exercise: A minimum of 30 min. of exercise 5 times per week or 50 min. 3 times per week of moderate intensity exercise (Borg 11-15). Daily household and/or transportation physical activity. 3.Diet: Increased intake of vegetables, legumes, fruits and berries, whole grain and fiber, low-fat dairy, vegetable fats; and use of "plate model". Total energy intake: 1600-1800 kcal/day, with 40-50 E% carbohydrates, 30-40 E% fats, 20-25 E% protein.

MEASUREMENTS of maternal variables:

AT THE MOMENT OF ENROLMENT TO THE STUDY, and every 3 months before pregnancy:

(1) Waist circumference, blood pressure, pulse, weight, height (2) i.e. 2-hour OGTT, fP-insulin, fP-glucose, , GHbA1c, lipids, P-hCRP, P-IL-6, S-A1Glypr, leptin. (3) Background questionnaire (4) 15-D-questionnaire: health-related quality of life. (7) Food diary (2+1). Exercise diaries daily for one week.

PREGNANCY At the end of each trimester: (1) The same tests and measurements as in pre-pregnancy period. 2h-OGTT at H10-14 and at H24-28. (2) Questionnaire, 15-D questionnaire, EDPS (=Edinburgh post-partum depression scale) questionnaire for screening mood disorders at H10-13. (4) Food diaries (2+1), and exercise diaries daily for one week at H10-13 and H34-36.

POST PARTUM PERIOD (Groups 1-2) At 6 weeks, 6 and 12 months post partum: (1) The same follow-up tests and measurements as at the beginning. Lipids checked only at 12 months post partum. (2) 2-hour OGTT 6 weeks and 12 months post partum (3) Questionnaires at all visits. (5) Food and exercise diaries at 12 months post partum.

MEASUREMENTS of child's variables at birth

(1) weight (2) height (3) head circumference (4) From delivery records: Mode of delivery, Apgar scores, any perinatal complications, operations, need of neonatal intensive care and length of hospital. (3) Laboratory tests from cord blood.

TIMETABLE Recruitment started in February 2008 and ended in autumn 2011 when about 800 subjects had been recruited to the study. Intervention will continue until 2014 (including pre- and postpartum periods). Long-term follow up of both mothers' and children's cohorts starts in 2014 and has been planned to continue up to 10 years postpartum. Data analysis starts in autumn of 2013 and results will be reported from 2014 onwards in international peer-reviewed journals.


Options:
A: Inclusion Criteria:

* obese (BMI \> 30)
* previous GDM

Exclusion Criteria:

* Age \< 18 years
* diabetes before pregnancy
* medication influencing glucose homeostasis
* hypertension
* multiple pregnancy
* physical disability
* substance abuse
* severe psychiatric disorders
* significant co-operation difficulties
B: Inclusion Criteria:

* children born to women who were part of the preceding LiP study and who completed the LiP study until birth. Inclusion criteria for the LiP study:
* singleton pregnant
* BMI \>/= 30 and \</= 45 E xclusion Criteria for preceding LiP study:
* Chronic diseases
* Not Danish speaking
* Abuse of alcohol or drugs
* Preterm delivery in earlier pregnancies
C: * 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.
D: Inclusion Criteria:

* Gestational age ≤ 12th week of gestation
* Age: 18 years to 43 years
* Prepregnancy BMI ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2
* Sufficient German language skills
* Written informed consent

Exclusion Criteria:

* Multiple pregnancy
* Any condition preventing physical activity such as placenta praevia, persistent bleeding, cervical incompetence
* Prepregnancy diabetes or early diagnosed gestational diabetes
* Uncontrolled chronic diseases (e.g. thyroid dysfunction)
* Psychiatric or psychosomatic diseases
* Any condition that may interfere with the study protocol

Answer: A