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

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Abstract: Background: 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. 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. Methods: This 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. Discussion: This 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 registration: The trial was registered on clinicaltrials.gov (NCT04134871) on 22 October 2019.
Original languageEnglish
Article number205
Pages (from-to)1-10
Number of pages10
JournalPilot and Feasibility Studies
Issue number1
Early online date15 Nov 2021
Publication statusPublished online - 15 Nov 2021

Bibliographical note

Funding Information:
The design of this feasibility study was informed by the Walk This Way study [21] which found that a coaching intervention aimed at improving physical activity and sedentary behaviour was feasible and acceptable to participants living in a densely populated urban area. The WORtH trial steering committee, comprising Dr. Fiona Gaughran, Dr. David Shiers and Dr. Brendon Stubbs, have provided valuable contribution to the development of the WORtH intervention. The WORtH project would not be possible without the support of the occupational therapy and physiotherapy clinicians in the Louth, Northern HSC trust and Western HSC trust community mental health teams. We would like to acknowledge the Northern Ireland Clinical Research Network Mental Health group and the staff supporting recruitment to the trial at the three study sites. We would like to thank Dr. Ilona McMullan for her contribution to preparation of the ethics application.

Funding Information:
The WORtH trial has been funded by the European Union’s INTERREG VA Programme, managed by the Special EU Programmes Body (SEUPB), awarded to the Health and Social Care Research & Development Division Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN) programme. Funding contributing to an extension required due to the impact of the COVID-19 pandemic was obtained from Public Health Agency Health and Social Care (HSC) Research & Development Division. The sponsor of this study is Ulster University, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB. The funders and sponsor of this study had no role in the design of this study and will not have any role in the collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication.

Publisher Copyright:
© 2021, The Author(s).


  • Study Protocol
  • Physical activity
  • Sedentary behaviour
  • Behaviour change
  • Severe mental illness
  • Behaviour Change
  • Severe Mental Illness
  • Sedentary Behaviour
  • Physical Activity


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