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

NCT07551960 | Enrolling By Invitation

• 2 other identifiers: INT2025004EK 69/25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

primary prevention; preventive cardiology; digital health; gamification; lifestyle intervention; body composition; cardiopulmonary fitness; HOMA-IR; coronary artery calcium score; telemedicine

Outcome Measures

Primary Outcomes (2)

• Change in AGEL Gamification Index (AGI) from Baseline to 12 Months

  Change in the composite AGEL Gamification Index (AGI), a platform-calculated score ranging from 0 to 100% that integrates 25 clinical, lifestyle, and psychosocial parameters. The AGI is computed algorithmically by the STELA platform based on standardized assessment data. Higher scores indicate better overall health risk profile. The target is a mean improvement of at least 5 percentage points at the cohort level.

  Baseline (T0) to 12 months (T+12)

• Protocol Feasibility and Participant Acceptability

  Proportion of enrolled participants who complete the full intervention program (all scheduled visits and assessments from T0 through T+12). Target: at least 80% complete protocol adherence. Additionally, participant satisfaction measured by a 5-point Likert scale questionnaire (target: at least 80% scoring 4 or 5 out of 5).

  12 months (T+12)

Secondary Outcomes (9)

• Change in Insulin Resistance (HOMA-IR) from Baseline to 12 Months

  Baseline (T0) to 12 months (T+12)

• Change in Body Composition from Baseline to 12 Months

  Baseline (T0) to 12 months (T+12)

• Change in Cardiorespiratory Fitness (VO2max) from Baseline to 12 Months

  Baseline (T0) to 12 months (T+12)

• Change in Muscle Strength from Baseline to 12 Months

  Baseline (T0) to 12 months (T+12)

• Change in Vitamin D Status from Baseline to 12 Months

  Baseline (T0) to 12 months (T+12)

Other Outcomes (3)

• Change in Lifestyle Behavior Scores

  Baseline (T0) to 12 months (T+12)

• Scalability Assessment

  Through study completion (up to 36 months)

• Open Validation Dataset

  Study completion (36 months)

Study Arms (1)

STELA Intervention

EXPERIMENTAL

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.

Behavioral: STELA Digital Preventive Medicine Platform; Diagnostic Test: Comprehensive Preventive Health Assessment

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.

STELA Intervention

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.

STELA Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years
• Indicated for primary cardiovascular prevention (no established cardiovascular, cerebrovascular, or other disease requiring secondary prevention)
• Able and willing to complete the full study assessment protocol
• Registered via online CPM portal or referred through AGEL network
• Willing and able to provide written informed consent

You may not qualify if:

• Established cardiovascular, cerebrovascular, or peripheral vascular disease requiring secondary prevention
• Pregnancy or breastfeeding
• Severe psychiatric disorder
• Active oncological disease
• Any acute or decompensated illness
• Inability to complete the study assessment protocol

Sponsors & Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.: lead

Study Sites (1)

Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi a.s.

Třinec, Moravian-Silesian Region, 73961, Czechia

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Dyslipidemias; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders

Study Officials

• Bogna Jiravska Godula, MD, PhD, MBA

  Nemocnice AGEL Trinec-Podlesi a.s.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Center for Preventive Medicine

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting approximately 6 months after primary publication (estimated 2029) and available indefinitely.
• Access Criteria: Available under CC BY-NC 4.0 license for academic use. Requests submitted to the Center for Preventive Medicine, Nemocnice AGEL Trinec-Podlesi.

Locations

CZ (1)