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The Melbourne Diabetes Prevention Study (MDPS) : study protocol for a randomized controlled trial

Davis-Lameloise, Nathalie, Hernan, Andrea, Janus, Edward D., Stewart, Elizabeth, Carter, Rob, Bennett, Catherine M., O'Reilly, Sharleen, Philpot, Benjamin, Vartiainen, Erkki and Dunbar, James A. 2013, The Melbourne Diabetes Prevention Study (MDPS) : study protocol for a randomized controlled trial, Trials, vol. 14, Article 31, pp. 1-9, doi: 10.1186/1745-6215-14-31.

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Title The Melbourne Diabetes Prevention Study (MDPS) : study protocol for a randomized controlled trial
Author(s) Davis-Lameloise, Nathalie
Hernan, AndreaORCID iD for Hernan, Andrea orcid.org/0000-0003-4542-1186
Janus, Edward D.
Stewart, Elizabeth
Carter, Rob
Bennett, Catherine M.
O'Reilly, SharleenORCID iD for O'Reilly, Sharleen orcid.org/0000-0003-3547-6634
Philpot, Benjamin
Vartiainen, Erkki
Dunbar, James A.ORCID iD for Dunbar, James A. orcid.org/0000-0003-0866-4365
Journal name Trials
Volume number 14
Season Article 31
Start page 1
End page 9
Total pages 9
Publisher BioMed Central
Place of publication London, England
Publication date 2013-01-31
ISSN 1745-6215
Keyword(s) protocol
randomized controlled trial
type 2 diabetes
prevention
lifestyle
intervention
Summary Background
Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.

As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program.

Methods/design
We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.

The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program.

Discussion

This study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically.
Notes Reproduced with the kind permission of the copyright owner.
Language eng
DOI 10.1186/1745-6215-14-31
Field of Research 111712 Health Promotion
Socio Economic Objective 920412 Preventive Medicine
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2013, BioMed Central
Persistent URL http://hdl.handle.net/10536/DRO/DU:30052699

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Created: Tue, 28 May 2013, 11:14:55 EST by Sharleen O'reilly

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.