Clinical trial NCT04134871: Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI
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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Schizophrenia
Bipolar Disorder
Major Depression
Psychosis
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Study recruitment rate
timeFrame: Through study completion, approx. 18 months
measure: Retention of study participants
timeFrame: Through study completion, approx. 18 months
measure: Level of acceptability assessed by semi-structured interviews
timeFrame: Data will be collected from participants at completion of the intervention, approx 3 months.
Secondary outcomes:
measure: Change in activity levels
timeFrame: Data will be collected at baseline and at completion of intervention, approx 3 months.
measure: Change in body weight (kilograms)
timeFrame: Data will be collected at baseline and at completion of intervention, approx 3 months.
measure: Change in waist circumference (cm)
timeFrame: Data will be collected at baseline and at completion of intervention, approx 3 months.
Other outcomes:
Locations:
city: Dundalk
country: Ireland
facility: Louth Meath Midlands HSE
state: Louth
city: Omagh
country: United Kingdom
facility: Western HSCT
state: Tyrone
city: Antrim
country: United Kingdom
facility: Northern HSCT
Study officials:
affiliation: Ulster University
name: Suzanne M McDonough, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.