A randomised controlled feasibility trial of an intervention to increase activity and reduce sedentary behaviour in people with severe mental illness: Walking fOR Health (WORtH) Study: Feasibility RCT WORtH

Objective: People with severe mental illness (SMI) engage in less physical activity (PA) and more people with SMI. sedentary behaviour (SB) than the general population, contributing to poorer physical health outcomes in this population. Therefore, the aim of this study was to evaluate the feasibility of a multi-component behaviour change intervention called WORtH, delivered by community mental health teams, aimed at increasing PA and reducing SB compared with a one-off education session in people with SMI.<br/><br/>Design: Feasibility randomised controlled trial.<br/><br/>Setting: Study recruitment and intervention delivery took place within four community mental health teams in United Kingdom and Ireland.<br/><br/>Participants: Eligible participants had a diagnosis of a severe mental illness and no contraindications to participating in physical activity. Fifty-four participants (25 male:29 female; mean age 51.6 years) were recruited. <br/><br/>Interventions: Participants were randomised to the 13-week WORtH intervention, comprising education, activity tracking and health coaching, or an education-only control.<br/><br/>Primary and secondary outcome measures: Feasibility outcomes included recruitment, retention, adherence and acceptability. Clinical outcomes included device-measured (Axivity AX3) and self-reported PA and SB, body anthropometry, physical function and mental wellbeing.<br/><br/>Results: This feasibility study met 90% target recruitment and 94% of participants provided follow-up data. Adherence to allocated intervention and engagement with all core intervention components was &gt;80%. Qualitative feedback indicated high levels of satisfaction. Valid device measured moderate-vigorous PA (MVPA), the intended primary outcome for a definitive trial, was obtained from 90% participants at baseline and 75% participants at post-intervention. Point estimates indicated a mean increase of 8.6 minutes/day of MVPA in the intervention group and of 1.0 minute/day in the control group.<br/><br/>Conclusions: The results of this study support the feasibility of the WORtH intervention in adults with SMI, and findings will be used to optimise the design of a definitive RCT.