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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT03086161
Eligibility Criteria:
Inclusion Criteria:
* 13-19 years of age and the 3-6 month old infants of these adolescent mothers
* Female
* Pregnant, 12-18 weeks gestation
* Patient in the Colorado Adolescent Maternity Program (CAMP) clinic
Exclusion Criteria:
* Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)
* Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder
* Medication affecting mood or body weight
* Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)
* Pre-pregnancy BMI \<5th percentile for age and sex
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
3 Months
Maximum Age:
19 Years
Study:
NCT03086161
Study Brief:
Protocol Section:
NCT03086161