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

Study Overview
=================
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.

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

Conditions
-----------------
Mental Illness, Schizophrenia, Bipolar Disorder, Major Depression, Psychosis

Intervention / Treatment
-----------------
* Behavioral: Group walk and one to one coaching


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions<br>|
| No Intervention: Control group<br>Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |