Effect of telemedicine-delivered lifestyle interventions in older adults during the COVID-19 pandemic: a nationwide two-arm randomized trial (PROACTIVE-19)

Abstract 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 ( β = 0.052, CI 0.026–0.074), smoking reduction among current smokers ( β = − 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 ( β = − 1.357, CI − 2.425 to − 0.187), particularly in women. However, BMI among participants with obesity increased in group B ( β = 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).