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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT03263351
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 12-17 years
* Body mass index (BMI) ≥85th percentile for age \& sex
* Center for Epidemiologic Studies-Depression Scale (CES-D) \>20
* English speaking
* ≥1 first- or second-degree family member with type 2 diabetes (T2D), prediabetes, or gestational diabetes
* Good general health
Exclusion Criteria:
* Pregnancy or breastfeeding
* Type 2 diabetes as indicated by fasting glucose≥126 mg/dL or 2-hour glucose\>200 mg/dL or Hba1c\>=6.5
* Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants
* Major psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, schizophrenia, conduct disorder, alcohol and substance abuse, and anorexia/bulimia nervosa
* Psychotherapy or structured weight loss program
* Active suicidal ideation or suicidal behavior
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT03263351
Study Brief:
Protocol Section:
NCT03263351