Contact information
Type
Scientific
Primary contact
Prof David French
ORCID ID
Contact details
Applied Research Centre in Health and Lifestyle Interventions
Whitefriars Building
Faculty of Health and Life Sciences
Priory Street
Coventry
CV1 5FB
United Kingdom
david.french@coventry.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8297; MRC: 85368
Study information
Scientific title
An explanatory randomised controlled trial to evaluate the efficacy of a brief walking intervention delivered in primary care in promoting walking behaviour
Acronym
Study hypothesis
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
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.
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
14/12/2009
Overall trial end date
31/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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.
Participant 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
Recruitment start date
14/12/2009
Recruitment end date
31/05/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Applied Research Centre in Health and Lifestyle Interventions
Coventry
CV1 5FB
United Kingdom
Sponsor information
Organisation
Coventry University (UK)
Sponsor details
Applied Research Centre in Health and Lifestyle Interventions
Whitefriars Building
Faculty of Health and Life Sciences
Priory Street
Coventry
CV1 5FB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: 85368)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24499405
Publication citations
-
Results
Williams SL, French DP, Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial., BMC Public Health, 2014, 14, 120, doi: 10.1186/1471-2458-14-120.