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
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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.
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