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

Sponsor
Nemocnice AGEL Trinec-Podlesi a.s.
Study ID
NCT07551960
Status
Enrolling By Invitation

Conditions

  • Cardiovascular Risk Factors
  • Dyslipidemias
  • Insulin Resistance
  • Metabolic Syndrome
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • STELA Digital Preventive Medicine Platform — BEHAVIORAL
    Comprehensive digital health platform integrating standardized assessment of 25 clinical, lifestyle, and psychosocial parameters into the AGEL Gamification Index (AGI, 0-100%). Intervention includes: (1) personalized lifestyle recommendations generated algorithmically by the STELA platform based on individual risk profiles; (2) interactive multimedia e-learning modules covering nutrition, physical activity, sleep hygiene, and stress management; (3) coordinated multidisciplinary referrals (physiotherapy, nutritional counseling, addiction services, optional health coaching); (4) automated digital reminders and telemedicine support; (5) motivational telephone contacts at 1 and 6 months post-enrollment; (6) real-time AGI tracking with visual feedback (spider and funnel charts) and automated comparison reports.
  • Comprehensive Preventive Health Assessment — DIAGNOSTIC_TEST
    Standardized multi-domain assessment protocol performed at baseline (T0) and 12 months (T+12), with selected parameters repeated at 6 months (T+6). Includes: (a) electronic questionnaires (lifestyle, psychosocial, medical history); (b) physical/functional tests: blood pressure, waist circumference, body composition (InBody bioimpedance), hand grip dynamometry, cardiopulmonary exercise test (VO2max by spiroergometry), Functional Movement Screen (FMS); (c) laboratory panel: lipid profile, apolipoprotein B, lipoprotein(a), HOMA-IR, high-sensitivity CRP, 25-OH vitamin D3, uric acid; (d) imaging: coronary artery calcium score (CT, participants over 30 years), transthoracic echocardiography, abdominal ultrasound, limited polysomnography.

Study Details

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.

Key Dates

First listed
Apr 27, 2026
Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: STELA Intervention
    All enrolled participants receive the full STELA preventive medicine intervention including comprehensive baseline assessment, personalized prevention plan based on AGI score, multimedia e-learning, multidisciplinary referrals, telemedicine support, and motivational contacts, with reassessment at 6 and 12 months.

Primary Outcome Measure

Change in AGEL Gamification Index (AGI) from Baseline to 12 Months [ Time Frame: Baseline (T0) to 12 months (T+12) ]

Find similar trials

Nationwide
Obesity / overweight trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies