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Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial.

Bayley, A; de Zoysa, N; Cook, DG; Whincup, PH; Stahl, D; Twist, K; Ridge, K; McCrone, P; Treasure, J; Ashworth, M; et al. Bayley, A; de Zoysa, N; Cook, DG; Whincup, PH; Stahl, D; Twist, K; Ridge, K; McCrone, P; Treasure, J; Ashworth, M; Greenough, A; Blythe, C; Winkley, K; Ismail, K (2015) Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial. Trials, 16. p. 112. ISSN 1745-6215 https://doi.org/10.1186/s13063-015-0593-5
SGUL Authors: Cook, Derek Gordon Whincup, Peter Hynes

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Abstract

BACKGROUND: Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective. METHODS/DESIGN: Individuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King's College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery. DISCUSSION: This RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the study include the ethnic and socioeconomic diversity of the study population and that, via social support within the group setting and long-term follow-up period, the intervention offers the potential to support maintenance of a healthy lifestyle. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).

Item Type: Article
Additional Information: © 2015 Bayley et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Cardiovascular Diseases, Clinical Protocols, Exercise, Humans, Life Style, Motivational Interviewing, Outcome Assessment, Health Care, Risk Factors, Sample Size, Humans, Cardiovascular Diseases, Clinical Protocols, Exercise, Risk Factors, Sample Size, Life Style, Motivational Interviewing, Outcome Assessment, Health Care, Cardiovascular disease, Physical activity, Diet, Accelerometer, Motivational interviewing, CBT, Primary care, Health trainers, Cardiovascular System & Hematology, General & Internal Medicine, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Trials
ISSN: 1745-6215
Language: eng
Dates:
DateEvent
25 March 2015Published
6 February 2015Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
10/62/03Department of Healthhttp://dx.doi.org/10.13039/501100000276
G1000758Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
PubMed ID: 25886569
Web of Science ID: WOS:000353016900001
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/113307
Publisher's version: https://doi.org/10.1186/s13063-015-0593-5

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