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
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,
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,
Richard Woodman
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
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
Richard Woodman
Public Health, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
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.
