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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.

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posted on 02.12.2021, 11:41 by Suzanne McDonoughSuzanne 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

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.

Funding

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.

Public Health Agency Health and Social Care (HSC) Research & Development Division.

Ulster University, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB.

History

Comments

The original article is available at https://pilotfeasibilitystudies.biomedcentral.com

Published Citation

McDonough SM. et al. 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. Pilot Feasibility Stud. 2021 Nov 15;7(1):205.

Publication Date

15 November 2021

PubMed ID

34782018

Department/Unit

  • Beaumont Hospital
  • School of Physiotherapy

Research Area

  • Population Health and Health Services

Publisher

BioMed Central

Version

  • Published Version (Version of Record)