Detailed protocol for the lifestyle intervention in the BeWEL randomised controlled trial of weight loss in adults who have had a colorectal adenoma
- 1Centre for Research into Cancer Prevention and Screening, Medical Research Institute, Population Health Sciences Division, University of Dundee, Dundee, UK
- 2Health Behaviour Unit, Department of Epidemiology and Public Health, University College London, London, UK
- 3Institute for Social Marketing, Stirling Management School, University of Stirling and the Open University, Stirling, UK
- Correspondence to Professor Annie Anderson;
- Received 5 April 2012
- Accepted 26 April 2012
- Published 25 May 2012
Introduction The BeWEL study is aimed at assessing the impact of a personalised lifestyle programme on body weight in people at risk of developing colorectal adenomas. The study is a two-arm multicentre randomised controlled trial comparing the BeWEL lifestyle programme against usual care. Over 12 months, 316 people who have had a colorectal adenoma removed through the national screening programme will be randomised to provide 80% power to detect a weight loss (primary outcome) of 7% over 12 months.
Methods The 12-month intervention will be delivered by lifestyle counsellors via three face-to-face visits followed by nine monthly telephone support calls. Consultant endorsement for the study will be stressed. An individualised caloric prescription based on estimates for weight maintenance −600 kcal will be calculated. Motivational interviewing techniques will be used to identify personal motivations for weight change and ways to improve perceived self-efficacy. The programme will utilise personalised diet and physical activity data from baseline measures to set behavioural goals. A range of behavioural strategies will be employed to support lifestyle change including goal setting, identifying specific implementation intentions, self-monitoring and feedback. Emphasis will be placed on self-monitoring body weight, and weighing scales will be provided. Programme acceptability will be explored postintervention with indepth interviews. Compliance and impact will be assessed by baseline and follow-up measures of diet by self-report, activity by accelerometry and anthropometry.
Ethics and dissemination Ethical approval has been obtained from the Tayside Committee on Medical Research Ethics. Dissemination of results will focus on publications in peer-reviewed journals, presentations at national/international cancer meetings and NHS groups. In addition, the work will be communicated to the public through forums such at The Scottish Cancer Prevention Network (http://www.cancerpreventionscotland.co.uk/). The trial is registered with Current Controlled Trials (International Standard Randomised Controlled Trials No: ISRCTN53033856).
To cite: Caswell S, Craigie AM, Wardle J, et al. Detailed protocol for the lifestyle intervention in the BeWEL randomised controlled trial of weight loss in adults who have had a colorectal adenoma. BMJ Open 2012;2:e001276. doi:10.1136/bmjopen-2012-001276
Contributors SC has prepared materials for intervention inclusion, advised on implementation strategies and drafted manuscript, AMC has advised on physical activity measures and tools, overall package design and manuscript drafting. JW has contributed advice on behavioural techniques, educational strategies and overall design components. MS has contributed to specific translation details from formative work into overall intervention, focusing on educational material and all communications. AA is the principal investigator for the study and has over seen the intervention design, development and implementation and manuscripts drafting and editing. All authors have contributed to intervention design, study design, final protocol and manuscript editing.
Funding The National Prevention Research Initiative (NPRI).
Competing interests None.
Ethics approval Ethical approval has been obtained from the Tayside Committee on Medical Research Ethics.
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement No additional data available.
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