Article Text

Protocol
Implementation, mechanisms of impact and key contextual factors involved in outcomes of the Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation
  1. Reindolf Anokye1,
  2. Simone Radavelli-Bagatini1,
  3. Catherine P Bondonno1,2,
  4. Marc Sim1,2,
  5. Lauren C Blekkenhorst1,2,
  6. Emma Connolly1,
  7. Nicola P Bondonno1,2,
  8. John T Schousboe3,
  9. Richard Woodman4,
  10. Kun Zhu2,5,
  11. Pawel Szulc6,
  12. Ben Jackson7,
  13. James Dimmock8,
  14. Markus P Schlaich2,
  15. Kay L Cox2,
  16. Douglas P Kiel9,
  17. Wai H Lim2,10,
  18. Amanda Devine1,
  19. Peter L Thompson11,
  20. Jenny Gianoudis12,
  21. Belinda De Ross12,
  22. Robin M Daly12,
  23. Jonathan M Hodgson1,2,
  24. Joshua R Lewis1,2,13,
  25. Mandy Stanley1
  1. 1School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
  2. 2Medical School, University of Western Australia, Perth, Western Australia, Australia
  3. 3Park Nicollet Osteoporosis Center and Health Partners Institute and Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota, USA
  4. 4Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, South Australia, Australia
  5. 5Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
  6. 6INSERM UMR1033, University of Lyon, Lyon, France
  7. 7School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Western Australia, Australia
  8. 8Department of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Queensland, Australia
  9. 9Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
  10. 10Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
  11. 11Department of Cardiology, University of Western Australia, Perth, Western Australia, Australia
  12. 12Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia
  13. 13Centre for Kidney Research, Children’s Hospital at Westmead, School of Public Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Reindolf Anokye; ranokye{at}our.ecu.edu.au

Abstract

Introduction The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on ‘healthful’ improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.

Methods and analysis The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing ‘healthful’ behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.

Ethics and dissemination The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.

Trial registration number ACTRN12618001087246.

  • public health
  • medical ethics
  • social medicine
  • qualitative research
  • statistics & research methods
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Twitter @AdMandydevine, @stanley_mandy

  • Contributors RA, SR-B, LCB, MSt., JMH and JRL developed the study concept. RA, MSt., JRL, JMH drafted the manuscript. RA, MSt, JRL, LCB, JD, BJ contributed to the design of the study and are responsible for study coordination. RA, SR-B, JRL, JD, BJ, DPK, JTS and JMH contributed to the design and development of the data collection instruments. RA will implement the protocol as well as oversee the collection of the qualitative data and will code all transcripts. RA and CPB will oversee the collection of the quantitative data. RA, MSi and NPB will be involved in the analysis of quantitative data. RA, SR-B, MSi, CPB, EC, RW, KZ, MSt., WHL, PS, RMD, KLC, AD, PLT, JG and BDR contributed to the writing of the study content. All authors contributed and approved the final manuscript.

  • Funding The salary of JRL is supported by a National Heart Foundation of Australia future leader fellowship (102817). DPK’s time was supported by a grant from the National Institute of Arthritis, Musculoskeletal and Skin Diseases (R01 AR 41398). The salary of JMH is supported by a National Health and Medical Research Council of Australia Senior Research Fellowship (ID 1116973). The salary of LCB is supported by an NHMRC of Australia Emerging Leadership Investigator Grant (ID: 1172987) and a National Heart Foundation of Australia Post-Doctoral Research Fellowship (ID: 102498). RA is supported by an Australian Government Research Training Program Scholarship (International).

  • Disclaimer None of the funding agencies had any role in the conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.

  • Competing interests None declared.

  • Patient consent for publication Not required.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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  • Cardiovascular medicine
    Simone Radavelli-Bagatini Catherine P Bondonno Marc Sim Lauren C Blekkenhorst Reindolf Anokye Emma Connolly Nicola P Bondonno John T Schousboe Richard J Woodman Kun Zhu Pawel Szulc Ben Jackson James Dimmock Markus P Schlaich Kay L Cox Douglas P Kiel Wai H Lim Mandy Stanley Amanda Devine Peter L Thompson Jenny Gianoudis Belinda De Ross Robin M Daly Joshua R Lewis Jonathan M Hodgson