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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT07236450
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years or older;
* Diagnosed with metabolic syndrome;
* Presence of at least one of the following ICPC-2 (International Classification of Primary Care - 2nd edition), used in primary health care:codes in the medical record:
* T83 (Overweight) or T82 (Obesity), with waist circumference ≥ 94 cm (men) or ≥ 80 cm (women)
* T89 (Non-insulin-dependent diabetes)
* T93 (Lipid metabolism disorder: HDL \< 40 mg/dl for men, \< 50 mg/dl for women; or triglycerides ≥ 150 mg/dl)
* K86 (Hypertension without complications) or K87 (Hypertension with complications);
* Access to a smartphone compatible with the mobile application;
* Does not currently use any physical activity monitoring device (e.g., pedometer, smartwatch, fitness tracker);
* Willing and able to provide informed consent.
Exclusion Criteria:
* No scheduled medical appointments in the past three years;
* Refusal to participate or withdraws consent;
* Change of primary care unit during the study period;
* Pregnant at the time of enrollment or becomes pregnant during the study;
* Diagnosed mental incapacity that prevents answering questionnaires;
* Does not own a smartphone;
* Inability to use a mobile application;
* Inability to use a physical activity tracking wristband.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07236450
Study Brief:
Protocol Section:
NCT07236450