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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT01809795
Eligibility Criteria:
Inclusion Criteria:
* Children 12 to 17 years old at the time of enrollment
* Children with a BMI ≥ 95th percentile for age
* Children participating in a weight management program at the CBHN.
Exclusion Criteria:
* Children/parents/guardians who appear unable to understand the study
* Children/parents appear unable to meet the requirements of participating, specifically not missing more than 1 consecutive week during the 12 week intervention
* Children who have a medical condition or development impairment that precludes them from participating in an exercise program
* Children who have type 2 diabetes
* Children who have been diagnosed with hypertension
* Children who are taking a statin
* Children who are pregnant or have given birth within 6 months
* Children with a history of significant cardiac disease leading to cardiovascular instability
* Children who have food allergies or are lactose intolerant
* Children who are unable to finish at least half of the smoothie while they taste it after the consent/assent process or decide after tasting the smoothie that they are no longer interested in participating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT01809795
Study Brief:
Protocol Section:
NCT01809795