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

Not Applicable

Completed

• Conditions: Major Depression; Schizophrenia; Bipolar Disorder; Psychosis; Mental Illness
• Interventions: Behavioral: Group walk and one to one coaching

• Registration Number: NCT04134871
• Lead Sponsor: University of Ulster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-22
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Group walk and one to one coaching	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

Primary Outcome Measures

Name	Time	Method
Study recruitment rate	Through study completion, approx. 18 months	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	Through study completion, approx. 18 months	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	Data will be collected from participants at completion of the intervention, approx 3 months.	Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Western HSCT; 🇬🇧 Omagh, Tyrone, United Kingdom

Northern HSCT; 🇬🇧 Antrim, United Kingdom

Louth Meath Midlands HSE; 🇮🇪 Dundalk, Louth, Ireland