Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol
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...
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e036366.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Robin M Daly |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-de6a0ce77d58466c9a8c6601faea52fa |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-de6a0ce77d58466c9a8c6601faea52fa2024-11-27T15:40:12ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2019-036366Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocolRobin M Daly0Pawel Szulc1Marc Sim2Wai H Lim3John T Schousboe4Douglas P Kiel5Joshua R Lewis6Amanda Devine7Kun Zhu8Peter L Thompson9Richard J Woodman10Simone Radavelli-Bagatini11Catherine P Bondonno12Lauren C Blekkenhorst13Reindolf Anokye14Emma Connolly15Nicola P Bondonno16Ben Jackson17James Dimmock18Markus P Schlaich19Kay L Cox20Mandy Stanley21Jenny Gianoudis22Belinda De Ross23Jonathan M Hodgson24School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia2Hospital Édouard Herriot – INSERM, Pavillon F, Lyon, FranceMedical School, The University of Western Australia, Perth, Western Australia, AustraliaMedical School, University of Western Australia, Perth, Western Australia, AustraliaPark Nicollet Osteoporosis Center and Health Partners Institute, Minneapolis, Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota, USADepartment of Medicine, Harvard Medical School, Boston, Massachusetts, USANutrition and Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaDepartment of Pathology, Shanghai Tenth People`s Hospital, Shanghai, ChinaMedical School, The University of Western Australia, Perth, Western Australia, AustraliaCollege of Medicine and Public Health, Flinders University, Adelaide, South Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia6 School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia1 School of Biomedical Engineering and Imaging Sciences, King`s College London, London, UKDepartment of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Queensland, Australia1 Dobney Hypertension Centre, Medical School, The University of Western Australia, Perth, Western Australia, AustraliaCentre for Aboriginal Medical and Dental Health, The University of Western Australia, Perth, Western Australia, AustraliaSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, AustraliaInstitute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, AustraliaInstitute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, AustraliaMedical School, The University of Western Australia, Perth, Western Australia, AustraliaIntroduction 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).https://bmjopen.bmj.com/content/10/11/e036366.full |
| spellingShingle | 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 Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol BMJ Open |
| title | Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol |
| title_full | Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol |
| title_fullStr | Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol |
| title_full_unstemmed | Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol |
| title_short | Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol |
| title_sort | modification of diet exercise and lifestyle model study a randomised controlled trial protocol |
| url | https://bmjopen.bmj.com/content/10/11/e036366.full |
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