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Background Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide. While a substantial proportion of CVD burden is attributable to modifiable risk factors, individual genetic susceptibility also contributes significantly. Polygenic risk scores (PRS) have emerged as promising tools to quantify inherited cardiovascular risk, while digital health technologies, such as wearable health devices (WHDs), provide new opportunities for continuous lifestyle monitoring However, the feasibility of integrating PRS and WHDs into primary prevention within public healthcare systems has not yet been systematically evaluated. Objective The FitPreV study aims to assess the feasibility of implementing PRS and WHDs in cardiovascular primary prevention among individuals with metabolic syndrome in the Italian National Health Service (SSN), focusing on their acceptability, practicality, and barriers to adoption in general practice. Methods FitPreV is a pilot, four-arm, randomized controlled feasibility study involving 120 adults aged 40–69 years diagnosed with metabolic syndrome and an estimated 10-year CVD risk between 2.5 and 10%. Participants will be randomly assigned to: (1) standard counseling; (2) counseling plus WHD; (3) counseling plus PRS; or (4) counseling plus both PRS and WHD. Data will be collected at baseline, 1, 6, and 12 months. Feasibility indicators include recruitment and retention rates, acceptability, burden and structural readiness. Secondary outcomes include changes in lifestyle behaviors, lipid profiles and cardiovascular risk (SCORE2 algorithm). Expected results The study will generate evidence on the operational feasibility and acceptability of integrating genetic risk assessment and digital monitoring tools into primary cardiovascular prevention within general practice settings. Conclusions By evaluating real-world implementation challenges, FitPreV will provide foundational evidence to guide larger-scale effectiveness trials studying personalized prevention approaches into national primary care settings. Trial registration https://clinicaltrials.gov/study/NCT06911294 , identifier: NCT06911294.
Tona et al. (2026) studied this question.