Walk this Way: a pilot study investigating the effect of a motivational pedometer based walking intervention to reduce sedentary behaviour and increase activity levels of people with serious mental illness
| ISRCTN | ISRCTN37724980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37724980 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | King's College London, King's College Hospital NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 04/08/2015
- Registration date
- 25/09/2015
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People with serious mental illness have a shorter life expectancy than the general population for many reasons including the effects of antipsychotic medication and unhealthy lifestyle. Walking is a simple and gentle form of exercise which may help people with psychosis lose weight. Breaking up sessions of sedentary behaviour (i.e., sitting or lying) can help prevent heart disease. We wish to test the feasibility of a 16-week intervention to increase physical activity and break up sessions of sedentary behaviour with people using adult community mental health services in Lambeth.
Who can participate?
Adult patients with a serious mental illness who are overweight, diabetic, smoke tobacco, or have a sedentary lifestyle, and who use adult community mental health services in Lambeth.
What does the study involve?
We will recruit 40 people and randomise them to 50% intervention and 50% control. We will collect outcome data on the person's level of activity (which will involve asking participants to wear an accelerometer for four days pre and post intervention) and wear a pedomoter during the intervention. We will also collect details of sociodemographics, physical health status, and mental well-being pre and post intervention. We will also undertake a process evaluation of the intervention to understand the experience of participants by interviewing participants after the intervention has finished. We will use the information from this study to plan for a larger Randomised Controlled Trial.
What are the possible benefits and risks of participating?
We hope that participants will benefit from improved physical health in terms of increased activity, possible weight loss and increased well-being. We do not foresee any risk for the participants but there is potential for a bruise to occur following the blood test and wearing the accelerometer may be burdensome for participants.
Where is the study run from?
South London and Maudsley NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
September 2015 to June 2016.
Who is funding the study?
National Institute for Health Research (UK).
Who is the main contact?
Julie Williams
julie.williams@kcl.ac.uk
Contact information
Public
CLAHRC South London
David Goldberg Centre
Institute of Psychiatry, Psychology & Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 5087 |
|---|---|
| julie.williams@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre small-scale randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Walk this Way: a pilot study investigating the effect of a motivational pedometer based walking intervention to reduce sedentary behaviour and increase activity levels of people with serious mental illness |
| Study objectives | Our study questions is: can we recruit people with serious mental illness, who also have physical risk factors, to a walking intervention and retain them in the intervention for 4 months? |
| Ethics approval(s) | NRES Committee - City Road and Hampsted, 21/08/2015, REC ref: 15/LO/1188 |
| Health condition(s) or problem(s) studied | Serious mental illness defined as schizophrenia, bipolar disorder or major depression |
| Intervention | Our intervention is a 4-month intervention to support people to be more active. This will include an initial group education session regarding the benefits of physical activity lasting approximately 2.5 hours, two weekly 'coaching' sessions with a mental health worker, and the provision of a pedometer to measure the number of steps taken. Participants will also be invited to a weekly walk. The control group will receive brief information on the benefits of being more active in one individual session. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Amount of sedentary behaviour and physical activity measured by an accelerometer which will be worn by participants for 4 days before and after the intervention |
| Key secondary outcome measure(s) |
1. BMI and waist circumference |
| Completion date | 01/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Has a serious mental illness 2. Is any of: overweight, diabetic, smokes tobacco, has a sedentary lifestyle 3. Uses secondary mental health services |
| Key exclusion criteria | 1. Has no physical health issue as listed in inclusion criteria 3. Is unable to give informed consent |
| Date of first enrolment | 01/09/2015 |
| Date of final enrolment | 31/10/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/09/2019 | 20/09/2019 | Yes | No |
| Protocol article | 12/12/2016 | 10/10/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/10/2023: Publication reference added.
20/09/2019: Publication reference and total final enrolment added.
