Open Access Study protocol

Study protocol for BeWEL: The impact of a BodyWEight and physicaL activity intervention on adults at risk of developing colorectal adenomas

Angela M Craigie1, Stephen Caswell1, Caron Paterson1, Shaun Treweek2, Jill JF Belch3, Fergus Daly4, Jackie Rodger5, Joyce Thompson6, Alison Kirk7, Anne Ludbrook8, Martine Stead9, Jane Wardle10, Robert JC Steele11 and Annie S Anderson1*

Author Affiliations

1 Centre for Research into Cancer Prevention and Screening, University of Dundee, UK

2 Quality, Safety & Informatics Research Group, University of Dundee and Tayside Clinical Trials Unit, UK

3 Vascular & Inflammatory Diseases Research Unit, University of Dundee, UK

4 Dental Health Services Research Unit, University of Dundee, UK

5 Colorectal Surgery, Ninewells Hospital and Medical School Dundee NHS Tayside, UK

6 Directorate of Public Health, Dundee NHS Tayside, UK

7 Department of Sport, Culture and The Arts, University of Strathclyde, Glasgow, UK

8 Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, UK

9 Institute for Social Marketing, University of Stirling and The Open University, UK

10 Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, UK

11 Department of Surgery and Molecular Oncology, Ninewells Medical School, University of Dundee, UK

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BMC Public Health 2011, 11:184  doi:10.1186/1471-2458-11-184

Published: 25 March 2011

Abstract

Background

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second highest cause of cancer death in the UK. Most cases occur in people over 50 years and CRC often co-exists with other lifestyle related disorders including obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). These diseases share risk factors related to the metabolic syndrome including large body size, abnormal lipids and markers of insulin resistance indicating common aetiological pathways.

Methods/Design

This 3 year study will be a two-arm, multicentre, randomised controlled trial comparing the BeWEL lifestyle (diet, physical activity and behaviour change) programme against usual care. The pre-trial development will take 6 months and participants will be recruited over a 12 month period and undertake the intervention and follow up for 12 months (total 24 months recruitment and intervention implementation) with a further 6 months for data collection, analysis and interpretation.

Four hundred and fifty two participants who have had a colorectal adenoma detected and removed (through the national colorectal screening programme) will provide 80% power to detect a weight loss of 7% over 12 months.

Primary outcomes are changes in body weight and waist circumference. Secondary outcomes will include cardiovascular risk factors, psycho-social measures and intervention costs.

Discussion

The results from this study will enhance the evidence base for lifestyle change in patients at higher risk of chronic disease including obesity related cancers.

International Standard Randomised Controlled Trials No: ISRCTN53033856