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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT04422951
Eligibility Criteria:
Inclusion Criteria:
* 10-16 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate
Exclusion Criteria:
* Medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy
Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone
Conditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason
Conditions limiting participation in the assessments - child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language
Unable to read, understand or complete informed consent in English or Spanish
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
16 Years
Study:
NCT04422951
Study Brief:
Protocol Section:
NCT04422951