Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol
Robin M Daly,
Pawel Szulc,
Marc Sim,
Wai H Lim,
John T Schousboe,
Douglas P Kiel,
Joshua R Lewis,
Amanda Devine,
Kun Zhu,
Peter L Thompson,
Richard J Woodman,
Simone Radavelli-Bagatini,
Catherine P Bondonno,
Lauren C Blekkenhorst,
Reindolf Anokye,
Emma Connolly,
Nicola P Bondonno,
Ben Jackson,
James Dimmock,
Markus P Schlaich,
Kay L Cox,
Mandy Stanley,
Jenny Gianoudis,
Belinda De Ross,
Jonathan M Hodgson
Affiliations
Robin M Daly
School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia
Pawel Szulc
2Hospital Édouard Herriot – INSERM, Pavillon F, Lyon, France
Marc Sim
Medical School, The University of Western Australia, Perth, Western Australia, Australia
Wai H Lim
Medical School, University of Western Australia, Perth, Western Australia, Australia
John T Schousboe
Park Nicollet Osteoporosis Center and Health Partners Institute, Minneapolis, Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota, USA
Douglas P Kiel
Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA
Joshua R Lewis
Nutrition and Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Amanda Devine
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Kun Zhu
Department of Pathology, Shanghai Tenth People`s Hospital, Shanghai, China
Peter L Thompson
Medical School, The University of Western Australia, Perth, Western Australia, Australia
Richard J Woodman
College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
Simone Radavelli-Bagatini
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Catherine P Bondonno
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Lauren C Blekkenhorst
6 School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Reindolf Anokye
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Emma Connolly
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Nicola P Bondonno
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Ben Jackson
1 School of Biomedical Engineering and Imaging Sciences, King`s College London, London, UK
James Dimmock
Department of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Queensland, Australia
Markus P Schlaich
1 Dobney Hypertension Centre, Medical School, The University of Western Australia, Perth, Western Australia, Australia
Kay L Cox
Centre for Aboriginal Medical and Dental Health, The University of Western Australia, Perth, Western Australia, Australia
Mandy Stanley
School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia
Jenny Gianoudis
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia
Belinda De Ross
Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia
Jonathan M Hodgson
Medical School, The University of Western Australia, Perth, Western Australia, Australia
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).
