Condition category
Mental and Behavioural Disorders
Date applied
04/08/2015
Date assigned
25/09/2015
Last edited
29/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Ms Julie Williams

ORCID ID

Contact details

CLAHRC South London
David Goldberg Centre
Institute of Psychiatry
Psychology & Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 5087
julie.williams@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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 four months?

Ethics approval

NRES Committee - City Road and Hampsted, 21/08/2015, REC ref: 15/LO/1188

Study design

Single-centre small-scale randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Condition

Serious mental illness defined as schizophrenia, bipolar disorder or major depression

Intervention

Our intervention is a four 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

Phase

Drug names

Primary outcome measures

Amount of sedentary behaviour and physical activity measured by an accelerometer which will be worn by participants for four days before and after the intervention

Secondary outcome measures

1. BMI and waist circumference
2. Self report sedentary behaviour and physical activity measured using the International Physical Activity Questionnaire
3. Motivation to engage in physical activity measured using the Behavioural Regulation in Exercise Questionnaire 2
4. insulin resistance, long-term blood glucose control, fasting lipids and c reactive protein measured from blood samples collected from participants
5. Mental well-being measured using the Warwick Edinburgh Mental Well-being Scale
6. Functional mobility measured using the Timed Get up and Go (TUG) Test
All outcomes, primary and secondary, will be measured at baseline and follow-up, which is at the end of the 16-week intervention.

Overall trial start date

01/09/2015

Overall trial end date

01/06/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Has no physical health issue as listed in inclusion criteria
3. Is unable to give informed consent

Recruitment start date

01/09/2015

Recruitment end date

31/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
SE9 8AA
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Organisation

King's College Hopsital NHS Foundation Trust (UK)

Sponsor details

161 Denmark Hill
London
SE5 8EF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We plan to publish in peer-reviewed journals, at conferences and in written reports to participants and service managers.

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes