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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT03750695
Eligibility Criteria:
Inclusion Criteria:
1. First trimester BMI ≥ 30.0 and \<45.0 kg/m2 (calculated from clinical weight and height)
2. Singleton gestation, between 23 weeks and 0/7 days and 28 weeks and 0/7 days
3. Normal fetal anatomy (no major structural abnormalities identified on standard of care survey before enrollment)
4. Established prenatal care at Women's Health Clinic before 18 weeks of gestation, plans to deliver at Barnes-Jewish Hospital
5. Permission from Obstetrics physician provider to participate in study.
Exclusion Criteria:
1. Gestational or pre-gestational diabetes diagnosis
2. Inability to provide voluntary consent
3. Currently using illegal drugs (e.g., cocaine, methamphetamine, opiates) (safety risk and potential confounding)
4. Current smoker who does not agree to stop (confounding)
5. Participation in routine (\>1x/week) exercise program (may improve glucose metabolism/vascular function)
6. History of heart disease, orthopedic, metabolic or neurological condition that would contraindicate exercise (safety risk)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03750695
Study Brief:
Protocol Section:
NCT03750695