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:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT01693666
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks gestation
* Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2
Exclusion Criteria:
* Aged \< 18 years or \> 40 years
* BMI \< 30 kg/m2 at study screening
* Multiple gestations
* Previously diagnosed with type 1 or type 2 diabetes mellitus
* Subjects will be excluded from the study if they present with any absolute or relative contraindications to exercise in pregnancy (as defined by ACOG); determined by completion of medical questionnaire by supervising physician
* Any evidence of:
i. Drug or alcohol abuse ii. Presence of any unstable psychiatric disorder iii. Plans to move away from the geographical area within the next nine months iv. Other medical or behavioral factors that, in the judgement of the supervising physician, may interfere with their ability to take part in a lifestyle intervention program during pregnancy.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01693666
Study Brief:
Protocol Section:
NCT01693666