A randomised controlled trial of a brief walking intervention

ISRCTN	ISRCTN95932902
DOI	https://doi.org/10.1186/ISRCTN95932902
Secondary identifying numbers	8297; MRC: 85368

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 13/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David French
Scientific

Applied Research Centre in Health and Lifestyle Interventions
Whitefriars Building
Faculty of Health and Life Sciences
Priory Street
Coventry
CV1 5FB
United Kingdom

Email	david.french@coventry.ac.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	An explanatory randomised controlled trial to evaluate the efficacy of a brief walking intervention delivered in primary care in promoting walking behaviour
Study objectives	Research objective: The aim of the present research is to conduct a definitive, fully powered explanatory trial to evaluate the efficacy of a brief intervention to increase walking, to be routinely delivered in primary care by practice nurses (PNs)/Healthcare Assistants (HCAs) to patients for whom increasing physical activity is a particular priority. The intervention already has demonstrated efficacy with a volunteer population, and has since been through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. This explanatory trial forms the fourth and final phase of a larger project for which we have secured funding. The overall aim of the present research therefore, is to conduct a fully powered, definitive explanatory trial to: 1. Assess the efficacy of the intervention in changing objective walking behaviour 2. Identify key intervention mechanisms by conducting a mediation analysis 3. Estimate the cost of the intervention and the difference in the cost of the resources used by patients in each arm of the trial, by conducting a full economic evaluation This explanatory trial will be a two-arm cluster randomised controlled trial, with clustering by GP practice. Allocation to experimental condition will be according to practice, stratified by practice size and Index of deprivation. Practice will be stratified by median practice size and index of deprivation for each of the three Primary Care Trusts (PCTs).
Ethics approval(s)	Birmingham, East, North and Solihull Research Ethics Committee approved on the 14th December 2009 (ref: 09/H1206/116). Amendments approved on the 4th March 2010.
Health condition(s) or problem(s) studied	Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Health Services Research
Intervention	Information provision and pedometer: Patients who choose to take part in the study will give informed consent. The PN/HCA will then give the patients a set of questionnaires to complete, and an information pack of materials promoting walking produced by the British Heart Foundation and Walking the Way to Health. The PN/HCA will answer any questions the patient may have about walking more, and continue to provide usual care for that patient with regard to walking. Motivation and volition to walk: This proposal builds on published and ongoing research conducted by Professor French and colleagues that has identified the principal psychological determinants of walking in a "well" adult volunteer sample. Following extended developmental work, a 15-minute intervention consisting of strategies to increase self-efficacy (confidence in ability to perform the behaviour), and enact "good intentions" was developed. Follow-up length: 6 months Study entry: multiple randomisations
Intervention type	Other
Primary outcome measure	Pedometer, measured at 1 week, 6 weeks and 6 months post-intervention
Secondary outcome measures	1. EQ-5D, measured at 6 months 2. Information on resource use, measured at 6 months 3. Theory of planned behaviour process measure, measured immediately post-intervention, 6 weeks and 6 months
Overall study start date	14/12/2009
Completion date	31/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 400; UK sample size: 400 Each PN/HCA will deliver the intervention to 20 eligible patients, referred by their GP/PN/HCA, giving a total of 400 patient recipients.
Key inclusion criteria	The anticipated recipients of the intervention are patients in primary care who: 1. Are aged between 16 and 65 years old, either sex 2. Have chronic conditions where physical activity has been shown to have a positive effect on health status, e.g., hypertension, type 2 diabetes (prediabetes, impaired glucose tolerance, insulin resistance), low back pain, fibromyalgia, coronary heart disease (CHD), cerebrovascular disease (CVD), hypercholesterolemia, osteoporosis and osteoarthritis, overweight or obese, or would otherwise benefit from increased walking 3. Are not currently being investigated/treated by secondary care specialists for the condition(s) or are awaiting investigation/treatment by secondary care specialists for the condition(s) 4. Are "sedentary" in terms of not meeting the 30 mins/day at least 5 times/ week guidelines 5. Are able to speak English (and therefore could potentially benefit from the PN/HT intervention session) 6. Do not have learning difficulties which would preclude active engagement with the intervention session 7. Do not have mental health problems, i.e., anxiety, depression which would preclude active engagement with the intervention session, or where the patient is being investigated/treated by secondary care specialists for the problem 8. Wish to participate 9. Are referred by their GP, practice nurse or health care assistant
Key exclusion criteria	1. Children aged less than 16 years 2. Adults aged over 65 years 3. Individuals unable to speak English (and therefore would not benefit from the intervention sessions) 4. People who are being investigated/treated by secondary care specialists 5. People with learning difficulties or mental illness which would preclude active engagement with the intervention session
Date of first enrolment	14/12/2009
Date of final enrolment	31/05/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Applied Research Centre in Health and Lifestyle Interventions

Coventry
CV1 5FB
United Kingdom

Sponsor information

Coventry University (UK)
University/education

Applied Research Centre in Health and Lifestyle Interventions
Whitefriars Building
Faculty of Health and Life Sciences
Priory Street
Coventry
CV1 5FB
England
United Kingdom

Website	http://wwwm.coventry.ac.uk/Pages/index.aspx
"ROR"	https://ror.org/01tgmhj36

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: 85368)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/02/2014		Yes	No