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 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT05595161
Eligibility Criteria:
Inclusion Criteria:
* Children ages 7-13 years with BMI ≥85th percentile and their parents;
* Child-parent dyads enrolled in the Bright Bodies intervention at each site will be eligible for inclusion in the evaluation study.
Exclusion Criteria:
* Children and/or parents who do not speak the language in which the program will be delivered at each site;
* Children and/or parents who plan to move away from the area within the next 15 months;
* Children with a history of purging and/or dramatic weight loss prior to the trial;
* Children who are currently participating in another high-intensity lifestyle intervention or other similar research study, or are planning to have bariatric surgery within the next six months
* Children whose EHR data cannot be accessed by the study teams;
* Children with chronic medical conditions limiting their ability to take food by mouth (e.g., g-tube fed, total parenteral nutrition), participate in physical activity (e.g., wheelchair bound), or meaningfully participate in group sessions (e.g., cognitive impairment);
* Children with a sibling enrolled in the trial
* Children who join the Bright Bodies program after the 4th week of a session (not including orientation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
13 Years
Study:
NCT05595161
Study Brief:
Protocol Section:
NCT05595161