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 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT01378806
Eligibility Criteria:
Inclusion Criteria: Inclusion criteria for children include:
* ability to speak, write, and read in English
* a BMI \> 85th percentile for age and gender
* at least one parent or guardian with a BMI \>25
* assent and their parent or guardian's consent to their participation
Inclusion criteria for parents or guardians include:
* ability to speak, write, and read in English
* a BMI \>25
* a 2nd, 3rd or 4th grade child with a BMI \> 85th percentile for age and gender
* reside with the child; and consent to join the study
Exclusion Criteria: Parents and children will be excluded if either has a:
* history of a heart murmur
* congenital heart disease
* family history of sudden death
* history of psychological problems such as claustrophobia that would prevent participation in group classes
* participation in another clinical trial or intervention
* Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT01378806
Study Brief:
Protocol Section:
NCT01378806