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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT06477120
Eligibility Criteria:
Inclusion criteria:
* Female based on sex assigned at birth
* Preconception body mass index (BMI) 35.0 - 60 kg/m2
* Singleton pregnancy
* Age 18-44 years old
* \< = 20 weeks gestational age
* Fluency in English to provide consent and complete study procedures
* Ability to provide informed consent
* Cleared by study doctor and the obstetrician/mid-wife provider to participate
* Access to a smartphone to complete intervention procedures
Exclusion criteria:
* Deemed medically high risk
* Multiple pregnancy (e.g., twins)
* Type 1 or 2 diabetes mellitus
* Early gestational diabetes (diagnosed at \< = to17 weeks gestational age through an oral glucose tolerance test)
* Currently eating ≤ 12 hours daily
* Autoimmune disorder (e.g., rheumatoid arthritis)
* iron deficiency anemia
* Inflammatory bowel disease
* Previous spontaneous preterm birth
* History of bariatric surgery
* Night shift work
* Currently incarcerated
* Eating disorder
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT06477120
Study Brief:
Protocol Section:
NCT06477120