Make My Day: primary prevention of stroke using engaging everyday activities as a mediator of sustainable health – a randomised controlled trial and process evaluation protocol

Abstract

IntroductionThe individual, societal and economic benefits of stroke prevention are high. Even though most risk factors can be reduced by changes to lifestyle habits, maintaining new and healthy activity patterns has been shown to be challenging.The aim of the study is to evaluate the impact of an interdisciplinary team-based, mHealth-supported prevention intervention on persons at risk for stroke. The intervention is mediated by engaging everyday activities that promote health. An additional aim is to describe a process evaluation that serves to increase knowledge about how the programme leads to potential change by studying the implementation process and mechanisms of impact.Methods and analysisThe study will be a randomised controlled trial including 104 persons at risk for stroke. Persons at risk of stroke (n=52) will be randomised to an mHealth-supported stroke prevention programme. Controls will have ordinary primary healthcare (PHC) services. The 10-week programme will be conducted at PHC clinics, combining group meetings and online resources to support self-management of lifestyle change using engaging everyday activities as a mediator. Primary outcomes are stroke risk, lifestyle habits and participation in health-promoting activities. Assessments will be performed at baseline and at follow-up (11 weeks and 12 months). The effects of the programme will be analysed using inferential statistics. Implementation will be analysed using qualitative and quantitative methods.Ethics and disseminationThe study has been approved by the Swedish Ethical Review Authority. Study results will be disseminated in peer-reviewed journals and at regional and international conferences targeting mixed audiences.Trial registration numberNCT05279508.