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

Primary Purpose

Mental Illness, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Group walk and one to one coaching
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Louth Meath Midlands HSE
  • Western HSCT
  • Northern HSCT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation.

Outcomes

Primary Outcome Measures

Study recruitment rate
The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.
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.
Level of acceptability assessed by semi-structured interviews
Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention

Secondary Outcome Measures

Change in activity levels
Participants' activity levels will be measured at baseline and end of intervention
Change in body weight (kilograms)
Participants' body weight will be measured at baseline and end of intervention
Change in waist circumference (cm)
Participants' waist circumference will be measured at baseline and end of intervention

Full Information

First Posted
September 6, 2019
Last Updated
May 10, 2023
Sponsor
University of Ulster
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1. Study Identification

Unique Protocol Identification Number
NCT04134871
Brief Title
Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI
Acronym
WORtH
Official Title
Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Schizophrenia, Bipolar Disorder, Major Depression, Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation.
Intervention Type
Behavioral
Intervention Name(s)
Group walk and one to one coaching
Intervention Description
Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions
Primary Outcome Measure Information:
Title
Study recruitment rate
Description
The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.
Time Frame
Through study completion, approx. 18 months
Title
Retention of study participants
Description
The number of participants that complete the study intervention versus the number of dropouts will be analysed along with reasons for drop out.
Time Frame
Through study completion, approx. 18 months
Title
Level of acceptability assessed by semi-structured interviews
Description
Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention
Time Frame
Data will be collected from participants at completion of the intervention, approx 3 months.
Secondary Outcome Measure Information:
Title
Change in activity levels
Description
Participants' activity levels will be measured at baseline and end of intervention
Time Frame
Data will be collected at baseline and at completion of intervention, approx 3 months.
Title
Change in body weight (kilograms)
Description
Participants' body weight will be measured at baseline and end of intervention
Time Frame
Data will be collected at baseline and at completion of intervention, approx 3 months.
Title
Change in waist circumference (cm)
Description
Participants' waist circumference will be measured at baseline and end of intervention
Time Frame
Data will be collected at baseline and at completion of intervention, approx 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne M McDonough, PhD
Organizational Affiliation
Ulster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louth Meath Midlands HSE
City
Dundalk
State/Province
Louth
Country
Ireland
Facility Name
Western HSCT
City
Omagh
State/Province
Tyrone
Country
United Kingdom
Facility Name
Northern HSCT
City
Antrim
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34782018
Citation
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.
Results Reference
derived

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

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