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Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening
  1. Annie S Anderson1,
  2. Angela Mary Craigie1,
  3. Stephanie Gallant1,
  4. Chloe McAdam2,
  5. E Jane Macaskill3,
  6. Nanette Mutrie2,
  7. Aileen Rae Neilson4,
  8. Ronan E O’Carroll5,
  9. Petra Rauchhaus6,
  10. Naveed Sattar7,
  11. Martine Stead8,
  12. Shaun Treweek9
  1. 1 Division of Cancer Research, Centre for Research into Cancer Prevention and Screening, Division of Population Health and Genomics, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK
  2. 2 Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, Edinburgh, UK
  3. 3 Department of Breast Surgery, NHS Tayside, Ninewells Hospital & Medical School, Dundee, UK
  4. 4 Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
  5. 5 Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, UK
  6. 6 Tayside Clinical Trials Unit, Tayside Medical Sciences Centre, Ninewells Hospital and Medical School, Dundee, UK
  7. 7 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
  8. 8 Institute for Social Marketing, University of Stirling, Stirling, UK
  9. 9 Health Services Research Unit, University of Aberdeen, Aberdeen, UK
  1. Correspondence to Professor Annie S Anderson; a.s.anderson{at}dundee.ac.uk

Abstract

Introduction In Scotland, the incidence of breast cancer is predicted to rise significantly in the next few decades and while there are measures to support reductions in morbidity and mortality, the breast cancer community is currently exploring preventative opportunities including supporting weight management programmes in postmenopausal women. This study aims to assess the effectiveness and cost-effectiveness of a theory-based, community delivered, minimal contact, weight management (diet, physical activity and behaviour change techniques) programme (ActWELL) in women with a body mass index (BMI) >25 kg/m2 attending routine breast cancer screening appointments.

Methods and analysis The study will be a four-centre, 1:1 parallel group randomised controlled trial of a 12-month weight management intervention initiated in breast cancer screening centres, delivered by trained Breast Cancer Now lifestyle coaches in community settings. The intervention programme involves two intervention meetings with coaches plus (up to) nine telephone contacts over 12 months. The programme will focus on personalised diet (including alcoholic and sugary drinks) and physical activity habits. Behaviour change techniques include self-monitoring, goal setting, implementation intentions, action and coping plans. The study has a sample size of 414 women with a BMI >25 kg/m2 attending routine National Health Service breast cancer screening appointments. Measures will be taken at baseline, 12 weeks and at 12-month follow-up, complemented by qualitative interviews exploring perceived acceptability and impact on habitual behaviours. The two co-primary outcomes are mean change in measured body weight and change in physical activity between groups to 12 months. Secondary outcomes are changes in eating habits, alcohol intake, sedentary time, quality of life, waist circumference, lipid, haemoglobin A1c and insulin profiles, blood pressure and cost-effectiveness of the intervention.

Ethics and dissemination The protocol has been approved by East of Scotland Research Ethics Committee (17/ES/0073). All participants provide written informed consent. Dissemination will be through peer-reviewed publication and conference presentations.

Trial registration number ISRCTN11057518; Pre-results.

  • cancer prevention
  • breast cancer
  • screening
  • lifestyle
  • behaviour modification

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors ASA is the principal investigator and has overall responsibility for all aspects of the ActWELL study. She initiated the study, designed the intervention, led on development of the protocol and drafting the manuscript. AMC, CM and NM were involved in intervention design and training, assessment methodology, finalising the protocol, reading, editing and approving the manuscript. SG is the trial manager and responsible for coordinating all aspects of the ActWELL study, drafting the protocol and reading, editing and approving the manuscript. EJM has responsibility for clinical issues, inclusion and exclusion criteria, trial design, finalising the protocol and reading, editing and approving the manuscript. ARN is responsible for health economics analysis, assessment methodology, finalising protocol and reading, editing and approving the manuscript. REO’C has responsibility for all psychological aspects of intervention design, assessment methodology, fidelity measures, finalising the protocol and reading, editing and approving the manuscript. PR is responsible for statistical design, analysis plan drafting protocol and reading, editing and approving the manuscript. NS is responsible for design of blood collection procedures, overseeing analysis of bloods, finalising protocol design and reading, editing and approving the manuscript. MS is responsible for formative qualitative analysis, intervention design, acceptability measures, finalising protocol and reading, editing and approving the manuscript. ST is responsible for trial design, recruitment strategies, day-to-day management decisions (with ASA and SG), finalising protocol reading, editing and approving the manuscript.

  • Funding This work was supported by The Scottish Government, grant number BC/Screening/17/01.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Ethical approval for this study was provided by East of Scotland Research Ethics Service (REC reference: 17/ES/0073). Our initial submission to ethics in January 2017 was withdrawn as we were advised to submit the formative work to the University of Dundee ethics committee (approved 5 April 2017, Ref 020/17) and the remainder to NHS ethics once the formative work was completed. It took several months to complete the formative work which delayed both the NHS ethics submission (approval provided on 22 June 2017) and the recruitment start date. This resulted in a delay in registering the study with ISCRTN until the final protocol was completed and the submission details updated. ISCRTN registration was assigned prospectively on 21 July 2017. Recruitment for the study commenced on 1 August 2017 with first participant randomised on 5 September 2017 due to the aforementioned project delay.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The authors are happy to provide data upon request to the corresponding author.

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