A study protocol for 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

Suzanne M Mcdonough,Duana Mcardle,Julie Williams,Mark A Tully,Catherine M Mcdonough,Judith Mcauley,Tony O’Neill,Ailsa Niven,Mike Clarke,Mary Clarke,Sarah C Howes,Iseult Wilson,Marie H Murphy,Maurice Dillon,John Brady,Emily Lait

doi:10.1186/s40814-021-00938-5

Abstract

BackgroundPeople with severe mental illness (SMI) are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population. There is a need to understand the feasibility and acceptability, and explore the effective components, of health behaviour change interventions targeting physical activity and sedentary behaviour in this population in rural and semi-rural settings.MethodsThis 13-week randomised controlled feasibility trial compares the Walking fOR Health (WORtH) multi-component behaviour change intervention, which includes education, goal-setting and self-monitoring, with a one-off education session. It aims to recruit 60 inactive adults with SMI via three community mental health teams in Ireland and Northern Ireland. Primary outcomes are related to feasibility and acceptability, including recruitment, retention and adherence rates, adverse events and qualitative feedback from participants and clinicians. Secondary outcome measures include self-reported and accelerometer-measured physical activity and sedentary behaviour, anthropometry measures, physical function and mental wellbeing. A mixed-methods process evaluation will be undertaken. This study protocol outlines changes to the study in response to the COVID-19 pandemic.DiscussionThis study will address the challenges and implications of remote delivery of the WORtH intervention due to the COVID-19 pandemic and inform the design of a future definitive randomised controlled trial if it is shown to be feasible.Trial registrationThe trial was registered on clinicaltrials.gov (NCT04134871) on 22 October 2019.

Highlights

People with severe mental illness (SMI) are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population
People with severe mental illness (SMI) experience a higher prevalence of preventable physical health conditions compared to the general population [1]
Longitudinal data indicates that people with SMI are more likely to have two or more comorbidities, with greater increases in the prevalence of comorbidities over time in people with SMI compared with the general population [1]

Summary

Introduction

People with severe mental illness (SMI) are less physically active and more sedentary than healthy controls, contributing to poorer physical health outcomes in this population. Systematic review evidence has shown that people with SMI are less physically active and spend more time in sedentary behaviour than healthy controls [4,5,6,7,8,9] They complete less moderate to vigorous physical activity than controls [9], with up to 70% not meeting physical activity guidelines [4, 10]. Higher levels of sedentary behaviour in SMI have been associated with poorer metabolic outcomes [11], while increased physical activity improves cardiometabolic risk [12] Interventions that support those who are inactive to replace sedentary time with small amounts of physical activity are likely to reduce the incidence and impact of cardiometabolic comorbidities in people with SMI [13,14,15]

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