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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT06666257
Eligibility Criteria:
The formative phase (Phase I), classified as exempt by the institutional review board will seek participation from individuals meeting the following criteria:
1. Currently pregnant or pregnant within the past 36 months.
2. Community partners with relevant perspectives to inform recruitment, adaptation approaches and feasibility of the phase 2 pilot trial.
Clinical Trial (Phase 2)
Inclusion Criteria:
* pregnant women less than 20 weeks of gestation at time of screening
* 18-45 years of age
* BMI of 25 - 40 kg/m-2
* Expecting a singleton pregnancy
* Smartphone and/or reliable internet access
* Willing to be identifiable to other study participants in the study program .
Exclusion Criteria:
* Smoker
* Preexisting medical conditions that might be exacerbated by pregnancy (e.g., diabetes mellitus, chronic renal failure, hypertension, malignancies, seizure disorder, lupus, drug or alcohol abuse, serious psychiatric disorders)
* Current mental health or eating disorder
* Contraindication to exercise (OB/GYN release is obtained prior to consent)
* Conceived with assisted fertility treatments
* Medications during pregnancy known to influence fetal growth (e.g., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)
* Plans to move out of the state in the next 6 months following screening.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06666257
Study Brief:
Protocol Section:
NCT06666257