Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT02768818
Eligibility Criteria:
Inclusion Criteria:
* Women aged between 20 and 40 with singleton pregnancies and BMI at recruitment \> 30 kg/m\^2 or a BMI\> 25 kg/m\^2 and the simultaneous presence of at least 1 of the following risk factors: age\> 35 years, previous fetal macrosomia (\> 4500gr), family history of diabetes (first-degree relative with type 2 diabetes mellitus), previous gestational diabetes mellitus.
* Adherence to lifestyle prescription including dietary counselling and physical activity stimulation
Exclusion Criteria:
* Subjects who require intervention in addition to the lifestyle changes women with diet and habits much different from the Mediterranean area (Central Africa, Asian, etc..). In such subgroup it will be difficult to obtain adherence to diet prescription since their cultural attitudes and dietary habits.
* Pre-pregnancy BMI\> 40 kg/m\^2
* Chronic hypertension
* Fasting glycemia in the first trimester of\> 126 mg / dl or random glycemia \> 200 mg/dl
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02768818
Study Brief:
Protocol Section:
NCT02768818