Condition category
Not Applicable
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
13/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://wwwm.coventry.ac.uk/Pages/index.aspx

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: 85368)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24499405

Publication citations

  1. 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.

Additional files

Editorial Notes