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A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care : study protocol

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French, David (David P.), Williams, Stefanie L., Michie, Susan, Taylor, Claire, Szczepura, Ala, Stallard, Nigel and Dale, Jeremy, 1958-. (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. ISSN 1471-2296

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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
Volume: Vol.12
Number: No.1
Page Range: p. 56
Identification Number: 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)
References:

1. Department of Health: At least five a week: Evidence on the impact of
physical activity and its relationship to health. London; 2004.
2. NHS Information Centre for health and social care: Health Survey for
England - 2008: Physical activity and fitness. Leeds; 2009.
3. Department of Health: Choosing activity: A physical activity action plan.
London; 2005.
4. Morris JN, Hardman AE: Walking to health. Sports Med 1997, 23:306-312.
5. Murphy MH, Nevill AM, Murtagh EM, Holder RL: The effect of walking on
fitness, fatness and resting blood pressure: A meta-analysis of
randomised, controlled trials. Prev Med 2007, 44:377-385.
6. Ogilvie D, Foster CE, Rothnie H, Cavill N, Hamilton V, Fitzsimons CF,
Mutrie N: Interventions to promote walking: Systematic review. BMJ 2007,
334:1204-1207.
7. National Institute for Health and Clinical Excellence: Four commonly used
methods to increase physical activity: Brief interventions in primary care,
exercise referral schemes, pedometers and community-based exercise
programmes for walking and cycling. London; 2006.
8. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P,
Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex
interventions to improve health. BMJ 2000, 321:694-696.
9. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petricrew M:
Developing and evaluating complex interventions: The new Medical
Research Council guidance. BMJ 2007, 337:979-983.
10. Darker CD, French DP, Longdon S, Morris K, Eves FF: Are beliefs elicited
biased by question order? A theory of planned behaviour belief
elicitation study about walking in the UK general population. Br J Health
Psychol 2007, 12:93-110.
11. Scott EJ, Eves FF, French DP, Hoppé R: The theory of planned behaviour
predicts self-reports of walking, but does not predict step count. Br J
Health Psychol 2007, 12:601-620.
12. Darker CD, French DP, Larkin M: An exploration of walking behaviour: An
interpretative phenomenological approach. Soc Sci Med 2007,
65:2172-2183.
13. Darker CD, French DP: How do people make sense of a theory of a
planned behaviour questionnaire on walking? A think-aloud study.
J Health Psychol 2009, 14:861-871.
14. Darker CD, French DP, Eves FF, Sniehotta FF: An intervention to promote
walking amongst the general population based on an “extended”
Theory of Planned Behaviour: A waiting list randomised controlled trial.
Psychol Health 2010, 25:71-88.
15. Ajzen I: The theory of planned behavior. Org Behav Hum Dec Proc 1991,
50:179-211.
16. Bandura A: Self-efficacy: The exercise of control. New York, Freeman; 1997.
17. Sniehotta FF, Schwarzer R, Scholz U, Schüz B: Action planning and coping
planning for long-term lifestyle change: Theory and assessment. Eur J
Soc Psychol 2005, 35:565-576.
18. Ajzen I: Perceived behavioural control, self-efficacy, locus of control, and
the theory of planned behavior. J App Soc Psychol 2002, 32:665-683.
19. Orbell S, Sheeran P: ’Inclined abstainers’: A problem for predicting healthrelated
behaviour. Brit J Soc Psychol 1998, 37:151-165.
20. Sniehotta FF, Scholz U, Schwarzer R: Action plans and coping plans for
physical exercise: A longitudinal intervention study in cardiac
rehabilitation. Br J Health Psychol 2006, 11:23-37.
21. French DP, Stevenson A, Michie S: An intervention to increase walking
requires both motivational and volitional components: A replication and
extension. Psychol Health Med .
22. Michie S, Williams S, Sniehotta FF, Dombrowski SU, Bishop A, French DP: A
refined taxonomy of behavior change techniques to help people
change their physical activity and healthy eating behaviors - The CALORE
taxonomy. Psychol Health .
23. Ashford S, Edmunds J, French DP: What is the best way to change selfefficacy
to promote physical activity? A systematic review with metaanalysis.
Br J Health Psychol 2010, 15:265-288.
24. Williams SL, French DP: What are the most effective intervention
techniques for changing physical activity self-efficacy and physical
activity behaviour - and are they the same? Health Educ Res 2011,
26:308-322.
25. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G,
Orwig D, Ernst D, Czajkowski S: Enhancing treatment fidelity in health
behaviour change studies: Best practices and recommendations from
the NIH Behavior Change Consortium. Health Psychol 2004, 23:443-451.
26. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ:
Patterns of intra-cluster correlation from primary care research to inform
study design and analysis. J Clin Epidemiol 2004, 57:785-794.
27. Miller WR, Rollnick S: Motivational interviewing: Preparing people for
change. New York: The Guilford Press;, second 2002.
28. Shilts MK, Horowitz M, Townsend MS: Goal setting as a strategy for
dietary and physical activity behavior change: A review of the literature.
Am J Health Promot 2004, 19:81-93.
29. Ajzen I: Constructing a TPB questionnaire: Conceptual and
methodological considerations.[http://people.umass.edu/aizen/pdf/tpb.
measurement.pdf], Dated January 2006; retrieved 23 Nov 2007.
30. Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL:
Methods for the economic evaluation of health care programmes.
Oxford: Oxford University Press; 20053.
31. EuroQol Group: EuroQol - a new facility for the measurement of healthrelated
quality of life. Health Policy 1990, 16:199-208.
32. Rabin R, de Charro F: EQ-5D: a measure of health status from the
EuroQol Group. Ann Med 2001, 33:337-343.
33. Department for Communities and Local Government: The English Indices
of Deprivation 2007. London; 2007.
34. Gelman A, Hill J: Data analysis using regression and multilevel/
hierarchical models. Cambridge: Cambridge University Press; 2007.
35. Preacher KJ, Hayes AF: Asymptotic and resampling strategies for
assessing and comparing indirect effects in multiple mediator models.
Behav Res Methods 2008, 40:879-891.
36. Sobel ME: Asymptotic confidence intervals for indirect effects in
structural equation models. In Sociological Methodology 1982. Edited by:
Leinhardt S. Washington DC: American Sociological Association;
1982:290-312.
37. National Institute for Health and Clinical Excellence: Guide to the methods
of technology appraisal. London; 2008.
38. Graves N, Walker D, Raine R, Hutchings A, Roberts JA: Cost data for
individual patients included in clinical studies: no amount of statistical
analysis can compensate for inadequate costing methods. Health Econ
2002, 11:735-739.
39. Richardson G, Manca A: Calculation of quality adjusted life years in the
published literature: a review of methodology and transparency. Health
Econ 2004, 13:1203-10.
40. Taylor C, Shaw RL, Dale J, French DP: Enhancing delivery of health
behaviour change interventions in primary care: A meta-synthesis of
views and experiences of primary care nurses. Patient Educ Couns.
URI: http://wrap.warwick.ac.uk/id/eprint/36780

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