Pilot Validation of the STELA Preventive Medicine Platform to Reduce Modifiable Health Risk Factors in Adults (CPM-STELA)

Brief summary (registry, in English)

This study evaluates a comprehensive digital health platform called STELA, developed at the Center for Preventive Medicine (CPM) of AGEL Hospital Trinec-Podlesi in Czechia. The STELA system is designed to identify, quantify, and reduce modifiable health risk factors in adults who have no established cardiovascular disease. Each participant undergoes a thorough baseline assessment including questionnaires (lifestyle, psychosocial, medical history), physical and functional tests (blood pressure, body composition via InBody, hand grip strength, cardiopulmonary exercise testing/VO2max, Functional Movement Screen), laboratory panel (lipid profile, ApoB, Lp(a), insulin resistance/HOMA-IR, hs-CRP, vitamin D3, uric acid), and imaging studies (coronary artery calcium score by CT in participants over 30 years, echocardiography, abdominal ultrasound, limited polysomnography). All data are entered into the STELA platform, which calculates a composite AGEL Gamification Index (AGI, scored 0-100%) with visual feedback via spider and funnel charts. Based on the AGI results, a 45-minute physician consultation using shared decision-making generates a personalized prevention plan. The intervention includes: interactive e-learning modules (nutrition, physical activity, sleep, stress management), coordinated referrals to physiotherapy, nutritional counseling, addiction services, and optional health coaching/hypnosis, automated digital reminders, a motivational telephone call at 1 month, and a follow-up clinical visit at 6 months with repeat laboratory and functional testing. A final comprehensive reassessment identical to baseline occurs at 12 months. The primary objective is to demonstrate that the STELA-guided intervention improves the overall AGI score at 12 months compared to baseline, and to confirm feasibility and acceptability of the protocol. Secondary objectives include improvement in individual risk biomarkers (insulin resistance/HOMA-IR, body composition, VO2max, muscle strength, vitamin D), participant adherence of at least 80%, patient satisfaction of at least 80%, and reduction of clinician administrative time by at least 50%. This is a single-arm pilot study enrolling at least 100 participants to establish feasibility, acceptability, and preliminary efficacy of the STELA system before a future multicenter randomized trial.

What you commit to

• Study type: Interventional
• Planned participants: 100
• From 1 Apr 2026 to the primary completion date, Dec 2028
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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