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

NCT04134871 | Completed

• 1 other identifier: 17/0078
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 3

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.

Conditions

Mental Illness; Schizophrenia; Bipolar Disorder; Major Depression; Psychosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in activity levels

  Data will be collected at baseline and at completion of intervention, approx 3 months.

• Change in body weight (kilograms)

  Data will be collected at baseline and at completion of intervention, approx 3 months.

• Change in waist circumference (cm)

  Data will be collected at baseline and at completion of intervention, approx 3 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Group walk and one to one coaching BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (3)

Louth Meath Midlands HSE

Dundalk, Louth, Ireland

Location

Western HSCT

Omagh, Tyrone, United Kingdom

Location

Northern HSCT

Antrim, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34782018 DERIVED

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Suzanne M McDonough, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: October 22, 2019
• Study Start: August 22, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (2)