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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07033767
Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents aged 4-17 years.
* Obesity defined as a BMI z-score ≥ 2 for age and sex, based on World Health Organization (WHO) reference standards.
* Stable or increasing BMI after at least 3 months of enrollment in the HEAL program.
* Inclusion of participants from all backgrounds, consistent with principles of equity, diversity, and inclusion.
* Participants and families who do not speak or read English will be included, provided interpreter services are available at LHSC's Children's Hospital.
* Participants who decline to enroll will continue receiving standard care in the HEAL program.
Exclusion Criteria:
* Known allergy to Sophora japonica (source of genistein).
* Diagnosis of type 2 diabetes (these patients are followed in a separate Diabetes Clinic).
* Current use of medications that may confound study outcomes, including:
* GLP-1 receptor agonists (e.g., Saxenda, Wegovy)
* ADHD medications (e.g., Concerta, Vyvanse, Abilify)
* Antipsychotic medications (e.g., Risperidone)
* Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT07033767
Study Brief:
Protocol Section:
NCT07033767