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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT01044134
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 85th percentile for sex and age according to CDC growth charts
* Access to a working telephone and cell phone
* At least one parent willing and able to participate in the intervention with the subject
* Residing in predominately one household (no more than one weekend every two weeks in a secondary household)
* Medical clearance from a primary care provider or treating physician to rule out any major medical illness, disability, or disorder (e.g., liver disease, renal failure, cancer)
Exclusion Criteria:
* Intake of more than 4 cups (250 mL per cup) of water per day
* BMI ≥ 40 kg/m2
* Currently smoking (\> 1 cigarette in the past week)
* Major surgery within the previous 6 months
* Does not have a primary care provider
* Physician diagnosis of a major medical illness (e.g. diabetes)
* Previous diagnosis of an eating disorder
* Physical, mental, or cognitive handicaps that prevent participation
* Chronic use of medications that may affect study outcomes (e.g. stimulants or diuretics)
* Another member of the family (first degree relative) or household participating in the study
* A friend, classmate or coworker participating in the study with whom they have contact with one or more times per week
* Girls who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT01044134
Study Brief:
Protocol Section:
NCT01044134