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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02979860
Eligibility Criteria:
Inclusion Criteria:
1. Parent-reported child race African American/Black.
2. Parent-reported child age of 8-11 years
3. Less than or equal to approximately 9.5 hours time in bed (TIB; based on actigraphy and sleep diaries)
4. Variability in Sleep Patterns (based on actigraphy and sleep diaries)
5. BMI for age and gender \> 85th percentile (but no greater than 100% overweight)
6. Self-reported parent age of 18 years, primary caretaker, and at home throughout the study (i.e., at bedtimes and wake times)
7. Reported willingness to complete all study tasks, including blood draws
Exclusion Criteria:
1. Diagnosable Sleep Disorder
2. Parent-reported diagnosis of medical or psychiatric condition that may impact sleep/weight status
3. Actively trying to lose weight
4. Inability to Understand or Complete Protocol
5. Sibling of enrolled subjects
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
11 Years
Study:
NCT02979860
Study Brief:
Protocol Section:
NCT02979860