French, David, Williams, Stefanie L., Michie, Susan, Taylor, Claire, Szczepura, Ala, Stallard, Nigel and Dale, Jeremy (2011) A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care : study protocol. BMC Family Practice, Vol.12 (No.1). p. 56. doi:10.1186/1471-2296-12-56

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Abstract

Background: The aim of the present research is to conduct a fully powered explanatory trial to evaluate the
efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care
by practice nurses (PNs) and Healthcare Assistants (HCAs) to patients for whom increasing physical activity is a
particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and
subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both
providers and recipients.
Methods/ Design: This two arm cluster randomised controlled trial set in UK general practices will compare two
strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised
to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques
designed to increase walking self-efficacy (confidence in ability to perform the behaviour), and to help people
translate their “good” intentions into behaviour change by making plans. Patients attending practices randomised
to the information provision arm will receive written materials promoting walking, and a short unstructured
discussion about increasing their walking.
The trial will recruit 20 PN/HCAs (10 per arm), who will be trained by the research team to deliver the selfregulation
intervention or information provision control intervention, to 400 patients registered at their practices
(20 patients per PN/HCA). This will provide 85% power to detect a mean difference of five minutes/day walking
between the self-regulation intervention group and the information provision control group. Secondary outcomes
include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socioeconomic
status, and clinical condition. A mediation analysis will investigate the extent to which changes in
constructs specified by the Theory of Planned Behaviour lead to changes in objectively assessed walking behaviour.
Discussion: This trial addresses the current lack of evidence for interventions that are effective at increasing
walking and that can be offered to patients in primary care. The intervention being evaluated has demonstrated
efficacy, and has been through an extensive process of adaptation to ensure acceptability to both provider and
recipient, thus optimising fidelity of intervention delivery and treatment receipt. It therefore provides a strong test
of the hypothesis that a self-regulation intervention can help primary care patients increase their walking.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Self-care, Health, Walking
Journal or Publication Title:	BMC Family Practice
Publisher:	BMC
ISSN:	1471-2296
Official Date:	23 June 2011
Dates:	Date Event 23 June 2011 Published
Date of first compliant deposit:	17 December 2015
Volume:	Vol.12
Number:	No.1
Page Range:	p. 56
DOI:	10.1186/1471-2296-12-56
Status:	Peer Reviewed
Access rights to Published version:	Open Access
Funder:	Medical Research Council (Great Britain) (MRC), NHS Warwickshire, NHS Coventry
Grant number:	G0701821 (MRC)

Data sourced from Thomson Reuters' Web of Knowledge

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