Multiple lifestyle behaviour mHealth intervention targeting Swedish college and university students: protocol for the Buddy randomised factorial trial

Abstract

IntroductionThe time during which many attend college or university is an important period for developing health behaviours, with potentially major implications for future health. Therefore, it is concerning that many Swedish students excessively consume alcohol, have unhealthy diets, are not physical active and smoke. The potential of digital interventions which integrate support for change of all of these behaviours is largely unexplored, as are the dismantled effects of the individual components that make up digital lifestyle behaviour interventions.Methods and analysisA factorial randomised trial (six factors with two levels each) will be employed to estimate the effects of the components of a novel mHealth multiple lifestyle intervention on alcohol consumption, diet, physical activity and smoking among Swedish college and university students. A Bayesian group sequential design will be employed to periodically make decisions to continue or stop recruitment, with simulations suggesting that between 1500 and 2500 participants will be required. Multilevel regression models will be used to analyse behavioural outcomes collected at 2 and 4 months postrandomisation.Ethics and disseminationThe study was approved by the Swedish Ethical Review Authority on 2020-12-15 (Dnr 2020-05496). The main concern is the opportunity cost if the intervention is found to only have small effects. However, considering the lack of a generally available evidence-based multiple lifestyle behaviour support to university and college students, this risk was deemed acceptable given the potential benefits from the study.Recruitment will begin in March 2021, and it is expected that recruitment will last no more than 24 months. A final data set will, therefore, be available in July 2023, and findings will be reported no later than December 2023.Trial registration numberISRCTN23310640; Pre-results.