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

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134871
• Other study ID #: 17/0078
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Major Depression
• Mental Disorders
• Mental Illness
• Psychosis
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Ireland	Louth Meath Midlands HSE	Dundalk	Louth
United Kingdom	Northern HSCT	Antrim
United Kingdom	Western HSCT	Omagh	Tyrone

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulster

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.