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

NCT ID: NCT04134871

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Illness Schizophrenia Bipolar Disorder Major Depression Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Group walk and one to one coaching

Intervention Type BEHAVIORAL

Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Group walk and one to one coaching

Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanne M McDonough, PhD

Role: PRINCIPAL_INVESTIGATOR

Ulster University

Locations

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Louth Meath Midlands HSE

Dundalk, Louth, Ireland

Site Status

Western HSCT

Omagh, Tyrone, United Kingdom

Site Status

Northern HSCT

Antrim, , United Kingdom

Site Status

Countries

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Ireland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34782018 (View on PubMed)

Other Identifiers

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17/0078

Identifier Type: -

Identifier Source: org_study_id

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