Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI (WORtH)

Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness

People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active.

A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them.

The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Major Depression; Mental Illness; Psychosis
• Intervention / Treatment: Behavioral: Group walk and one to one coaching

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah C Howes, PhD; Phone Number: +442895367226; Email: s.howes@ulster.ac.uk
• Study Contact Backup: Name: Suzanne M McDonough, PhD; Phone Number: +35314022396; Email: suzannemcdonough@rcsi.ie

Study Locations

• Ireland
  • Louth
    • Dundalk, Louth, Ireland
      • Louth Meath Midlands HSE
• United Kingdom
  • Antrim, United Kingdom
    • Northern HSCT
  • Tyrone
    • Omagh, Tyrone, United Kingdom
      • Western HSCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inactive adults (Male or Female; aged ≥18 years)
• Diagnosis of any SMI (schizophrenia, psychosis, bipolar disorder and major depression).

Exclusion Criteria:

• Significant movement impairment
• Identified as 'Active' using the GPPAQ screening tool
• Unable to understand English or lack comprehension to understand the purpose of the study and given written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants randomised to the intervention group will be invited to attend a group education session where they will be given a step counter and activity diary, they will be invited to weekly group walks and fortnightly coaching 1-1 sessions aimed at setting and reviewing goals to increase physical activity and reduce sedentary behaviour	Behavioral: Group walk and one to one coaching; Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions
No Intervention: Control group; Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study recruitment rate	The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.	Through study completion, approx. 18 months
Retention of study participants	The number of participants that complete the study intervention versus the number of dropouts will be analysed along with reasons for drop out.	Through study completion, approx. 18 months
Level of acceptability assessed by semi-structured interviews	Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention	Data will be collected from participants at completion of the intervention, approx 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activity levels	Participants' activity levels will be measured at baseline and end of intervention	Data will be collected at baseline and at completion of intervention, approx 3 months.
Change in body weight (kilograms)	Participants' body weight will be measured at baseline and end of intervention	Data will be collected at baseline and at completion of intervention, approx 3 months.
Change in waist circumference (cm)	Participants' waist circumference will be measured at baseline and end of intervention	Data will be collected at baseline and at completion of intervention, approx 3 months.

Collaborators and Investigators

• Sponsor: University of Ulster
• Investigators: Principal Investigator: Suzanne M McDonough, PhD, Ulster University

Publications and helpful links

General Publications

• McDonough SM, Howes SC, Dillon M, McAuley J, Brady J, Clarke M, Clarke M, Lait E, McArdle D, O'Neill T, Wilson I, Niven A, Williams J, Tully MA, Murphy MH, McDonough CM. 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. doi: 10.1186/s40814-021-00938-5.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: 17/0078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No