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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05600205
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older;
* Diagnosed with a severe mental illness (SMI; defined as within treatment of a FACT team);
* Excessive abdominal circumference (≥102 cm for men or ≥ 88 cm for women; this is one of five risk factors for metabolic syndrome);
* Presence of at least one of the other four risk factors as clustered in the criteria for metabolic syndrome (hypertension, abnormal triglycerides, fasting blood sugar and HDL cholesterol, or medication use for blood pressure or values).
Exclusion Criteria:
* If someone lacks the legal capacity to give independent consent for participation and no (legal) representative is willing to give consent;
* If the disease severity at that time does not permit participation (i.e. acute psychological state, acute psychosis, or suicidality).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05600205
Study Brief:
Protocol Section:
NCT05600205