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Cardiovascular medicine
Protocol
Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol
  1. Simone Radavelli-Bagatini1,
  2. Catherine P Bondonno1,2,
  3. Marc Sim1,2,
  4. Lauren C Blekkenhorst1,2,
  5. Reindolf Anokye1,
  6. Emma Connolly1,
  7. Nicola P Bondonno1,2,
  8. John T Schousboe3,
  9. Richard J 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. Mandy Stanley1,
  19. Amanda Devine1,
  20. Peter L Thompson11,
  21. Jenny Gianoudis12,
  22. Belinda De Ross12,
  23. Robin M Daly12,
  24. Joshua R Lewis1,2,13,
  25. Jonathan M Hodgson1,2
  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 UMR 1033, University of Lyon, Hospices Civils de Lyon, Lyon, France
  7. 7Faculty of Science, School of Human Sciences, 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 SeniorLife, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
  10. 10Department of Renal Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
  11. 11Department of Cardiology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
  12. 12Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Melbourne, VIC, Australia
  13. 13Centre for Kidney Research, Children's Hospital at Westmead, School of Public Health, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia
  1. Correspondence to Dr Simone Radavelli-Bagatini; simoneradavelli{at}hotmail.com

Abstract

Introduction Most cardiovascular disease (CVD)-related events could be prevented or substantially delayed with improved diet and lifestyle. Providing information on structural vascular disease may improve CVD risk factor management, but its impact on lifestyle change remains unclear. This study aims to determine whether providing visualisation and pictorial representation of structural vascular disease (abdominal aortic calcification (AAC)) can result in healthful diet and lifestyle change.

Methods and analysis This study, including men and women aged 60–80 years, is a 12-week, two-arm, multisite randomised controlled trial. At baseline, all participants will have AAC assessed from a lateral spine image captured using a bone densitometer. Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks. All participants will receive information about routinely assessed CVD risk factors and standardised (video) diet and lifestyle advice with three simple goals: (1) increase fruit and vegetable (FV) intake by at least one serve per day, (2) improve other aspects of the diet and (3) reduce sitting time and increase physical activity. Clinical assessments will be performed at baseline and 12 weeks.

Outcomes The primary outcome is a change in serum carotenoid concentrations as an objective measure of FV intake. The study design, procedures and treatment of data will adhere to Standard Protocol Items for Randomized Trials guidelines.

Ethics and dissemination Ethics approval for this study has been granted by the Edith Cowan University and the Deakin University Human Research Ethics Committees (Project Numbers: 20513 HODGSON and 2019-220, respectively). Results of this study will be published in peer-reviewed academic journals and presented in scientific meetings and conferences. Information regarding consent, confidentiality, access to data, ancillary and post-trial care and dissemination policy has been disclosed in the participant information form.

Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN12618001087246).

  • nutrition & dietetics
  • public health
  • vascular medicine
http://creativecommons.org/licenses/by-nc/4.0/

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/.

https://doi.org/10.1136/bmjopen-2019-036366

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    Footnotes

    • Twitter @stanley_mandy, @AdMandydevine

    • RMD, JRL and JMH contributed equally.

    • Contributors JMH, JRL and RD contributed to the development of the study concept. SR-B, CPB, MS, LB, RA, EC, NPB, JTS, RW, KZ, PS, BJ, JD, MPS, KLC, DPK, WHL, MPS, AD, PLT, JG, BDR, RD, JRL and JMH provided input on the study design and eligibility criteria for the study. SR-B, CPB, MS, LB, BJ, JD, MPS, RD, JRL and JMH developed the script for both videos on diet and lifestyle recommendations and the handout. CPB created the video on diet and lifestyle and the booklet for the counselling session. NPB assisted with the methodology of the clinical trial. EC and MS voiced over the video on diet and lifestyle. All authors assisted in further development and implementation of the protocol. SR-B, CPB, MS, LB, RA, EC, JG and BDR are involved in the acquisition of data. JTS, PS and JRL had input in the development of the graphic images of the AAC results. RW created the randomisation codes and had input in the statistical analysis plan. KZ is responsible for the bone density scans. MPS, DPK, WHL and PLT provided clinical input. BJ and JD contributed to the development and evaluation of the instruments to capture behaviour change and individual’s wellbeing. MPS voiced over the video on atherosclerosis and is the clinician responsible for checking the clinical/medical tests of the study. KLC helped to develop the information on physical activity and to choose the instruments to measure physical activity and the physical function tests. AD assisted with the dietary aspects of the study. SRB, JRL and JMH contributed to drafting of the protocol and provided approval for the version submitted for publishing. JRL, JMH and CPB are supervisors for the PhD candidate (SR-B). SR-B, CPB, MS, LB, RA, EC, NPB, JTS, RW, KZ, PS, BJ, JD, MPS, KLC, DPK, WHL, MPS, AD, PLT, JG, BDR, RD, JRL and JMH contributed and approved the final manuscript.

    • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors’. The salary of JRL is supported by a National Heart Foundation of Australia future leader fellowship (ID 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).

    • Competing interests None declared.

    • Patient consent for publication Not required.

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

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