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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT03329300
Eligibility Criteria:
Inclusion Criteria:
1. Have a BMI ≥ 85th percentile
2. Are ≥8 and ≤12 years old at the beginning of treatment
3. Can read, write, and speak English, along with their parent
4. Plan to stay living within the local area during the study period
5. Have a consenting parent who can commit to all study procedures and provide reliable travel.
* Siblings will be eligible for study inclusion if they meet the above criteria and will be allowed to use the same participating parent (sibling effects would then be addressed in statistical analyses).
Exclusion Criteria:
1. Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
2. Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program
3. Have been diagnosed with an intellectual disability or traumatic brain injury
4. Have medical contraindications to physical activity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT03329300
Study Brief:
Protocol Section:
NCT03329300