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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT07246603
Eligibility Criteria:
Adolescent Inclusion Criteria:
* English or Spanish-speaking
* 12-15 years of age
* Receiving care at a participating clinic
* Body Mass Index (BMI) ≥95% and \<120% of the 95%
* Access to a mobile device with a webcam that can receive texts
Parent Inclusion Criteria:
* English or Spanish-speaking
* Primary legal guardian ≥18 years of age living with the adolescent
Exclusion Criteria:
* conflicts that would inhibit the ability to participate in all aspects of the study as outlined in the study protocol
* family plans to move outside of the study area or plans to no longer be a patient at a participating clinic in the 12 month study period
* the primary care provider or PI determines that the study is not clinically or medically appropriate (e.g., significant psychiatric, cognitive, physical or developmental conditions that would impair their ability to complete assessments, participate in study sessions, or conduct physical activity) based on screening at study onset
* adolescent exhibits severe dietary restriction or compensatory behavior (e.g., vomiting, laxative abuse) based on screening at study onset and clinical interview by a study psychologist
* adolescent is currently pregnant/plans to become pregnant during study period
* adolescent is participating in another weight loss program, has had or plans to undergo weight loss surgery
* adolescent has a chronic medical condition(s) and/or uses medication that substantially impacts or interferes with growth, appetite, weight or physical activity participation
* adolescents taking anti-obesity medication are ineligible if they are not a stable dose for at least 3 months prior to study participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
15 Years
Study:
NCT07246603
Study Brief:
Protocol Section:
NCT07246603