DOI record: { "DOI": "10.1007/s11357-026-02585-1", "ISSN": [ "2509-2723" ], "URL": "http://dx.doi.org/10.1007/s11357-026-02585-1", "abstract": "<jats:title>Abstract</jats:title>\n <jats:p>\n Older adults are at increased risk of severe COVID-19 outcomes, yet randomized evidence on structured lifestyle interventions in this context remains limited. We aimed to evaluate the effects of a personalized lifestyle intervention on health-related behaviors and adverse outcomes among adults aged ≥ 60 years during the COVID-19 pandemic. PROACTIVE-19 was a nationwide, open-label, randomized trial initiated in Hungary in March 2020, during the first wave of the COVID-19 pandemic. Participants aged ≥ 60 years were randomly assigned (1:1) to general (group A) or personalized (group B) lifestyle counselling delivered via telephone, targeting mental health, smoking, physical activity, diet, and alcohol consumption. The primary planned endpoint was a composite of COVID-19 severity outcomes; however, due to infection rates, all-cause mortality was assessed. Longitudinal lifestyle changes were evaluated using linear mixed-effects models with bootstrap 95% confidence intervals (CIs) in a modified intention-to-treat population. A total of 441 participants were analyzed (214 group A; 227 group B). All-cause mortality did not differ significantly between groups (HR = 0.66, 95% CI 0.28–1.53). Significant overall time effects were observed for fruit and vegetable consumption (\n <jats:italic>β</jats:italic>\n  = 0.052, CI 0.026–0.074), smoking reduction among current smokers (\n <jats:italic>β</jats:italic>\n  = − 0.372, CI − 0.528 to − 0.222), and psychological variables. A significantly greater reduction in estimated alcohol consumption was observed in group B among baseline drinkers compared with group A (\n <jats:italic>β</jats:italic>\n  = − 1.357, CI − 2.425 to − 0.187), particularly in women. However, BMI among participants with obesity increased in group B (\n <jats:italic>β </jats:italic>\n = 0.068, CI 0.013–0.119). Seasonal and pandemic-wave effects significantly influenced physical activity and psychological distress. The personalized intervention was not associated with a significant reduction in all-cause mortality. Several lifestyle behaviors improved over time; however, the additional benefit of personalization was limited (Supported by the Semmelweis University Research, Development and Innovation Fund, ClinicalTrials.gov number, NCT04321928).\n </jats:p>", "alternative-id": [ "2585" ], "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "18 May 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "4 October 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "19 October 2026" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Ethical approval", "name": "Ethics", "order": 1, "value": "The trial was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/2428–2/2020/EKU). Due to the pandemic, participants provided verbal consent via telephone, as authorized by a special government decree. Data were handled in accordance with the study’s data management plan, ensuring participant confidentiality and the secure handling of personal health information." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Consent to participate", "name": "Ethics", "order": 2, "value": "Informed consent was obtained from all participants prior to enrolment via telephone using a mobile-based system, in accordance with the applicable regulatory framework during the COVID-19 pandemic." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Consent for publication", "name": "Ethics", "order": 3, "value": "The corresponding author accepts responsibility for releasing this material on behalf of any and all co-authors." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Conflict of interest", "name": "Ethics", "order": 4, "value": "The authors declare no competing interests." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Declaration of generative AI and AI-assisted technologies", "name": "Ethics", "order": 5, "value": "AI-assisted technologies were used to support grammar review of the manuscript and the development of Python code for statistical analyses. 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