Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI (WORtH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04134871|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Mental Illness Schizophrenia Bipolar Disorder Major Depression Psychosis||Behavioral: Group walk and one to one coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||August 22, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: Intervention group
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
Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions
No Intervention: Control group
Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation.
- Study recruitment rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Change in activity levels [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134871
|Contact: Sarah C Howes, PhDfirstname.lastname@example.org|
|Contact: Suzanne M McDonough, PhDemail@example.com|
|Louth Meath Midlands HSE||Recruiting|
|Dundalk, Louth, Ireland|
|Contact: C McDonough, MD|
|Contact: M Dillon|
|Western HSCT||Not yet recruiting|
|Omagh, Tyrone, United Kingdom|
|Contact: J Brady, MD|
|Northern HSCT||Not yet recruiting|
|Antrim, United Kingdom|
|Contact: J McAuley, MD|
|Principal Investigator:||Suzanne M McDonough, PhD||Ulster University|