Digital lifestyle management application (levidex) for empowerment and health behaviour change in early multiple sclerosis - Results of the randomised controlled POWER@MS1 trial.

Background: This randomised controlled trial investigated the effect of a personalised digital lifestyle management application ('levidex') on inflammatory disease activity in newly diagnosed people with MS (pwMS), compared to a non-personalised application ('dexilev') that covered similar lifestyle-related content.

Methods: Participants ( = 234) were recruited from July 2019 to April 2022 in 20 study centres in Germany and randomised to levidex (intervention group (IG), = 115) or 'dexilev' (control group (CG), = 119). Follow-up data was collected over 1-2 years. The combined primary endpoint (new T2 lesion and/or relapse) was analysed using Cox proportional hazards regression. Key secondary endpoints included self-reported quality of life and health behaviour.

Results: There was no difference in the time to the first relapse and/or new T2 lesion between IG and CG (Hazard Ratio: 0.91; 95% confidence interval [CI]: [0.66, 1.27], = 0.596). After 3 months, self-reported diet quality was higher in the IG (0.43; 95% CI: [0.14, 0.72], = 0.0037). There was no difference in other secondary endpoints between IG and CG after 3 and 12 months.

Conclusions: This study failed to meet its primary endpoint and usage of levidex did not differ from dexilev in its effects on inflammatory disease activity or behaviour change in this cohort of pwMS.