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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02634593
Eligibility Criteria:
Inclusion Criteria:
* African American race
* Healthy, singleton pregnancy
* ≤ 28 weeks' gestation at enrollment
* BMI of 30.0 - 45.9 kg/m2 at first prenatal visit
* Reports regular food consumption after 8pm at night that is not attributable to work schedule or other constraints.
Exclusion Criteria:
* pre-gestation or gestational diabetes
* current smoker
* presence of any medical condition or the use of any medication known to affect fetal growth
* previous delivery of a small-for-gestational age infant (\<10th percentile)
* previous delivery of a pre-term infant (\<36.0 weeks' gestation)
* inability to communicate in both verbal and written English
* unwilling or unable to consume study-provided foods.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
45 Years
Study:
NCT02634593
Study Brief:
Protocol Section:
NCT02634593