Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Jan 31:14:31.
doi: 10.1186/1745-6215-14-31.

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

Nathalie Davis-Lameloise  1 , Andrea Hernan, Edward D Janus, Elizabeth Stewart, Rob Carter, Catherine M Bennett, Sharleen O'Reilly, Benjamin Philpot, Erkki Vartiainen, James A Dunbar; Melbourne Diabetes Prevention Study (MDPS) research group
Affiliations
Randomized Controlled Trial

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

Nathalie Davis-Lameloise et al. Trials. .

Abstract

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.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000507280.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart of the MDPS.
Figure 2
Figure 2
Structure of the MDPS Group Program. IS: Individual session.S1-S5: group sessions.T1, T2, T3: anthropometric and laboratory tests.
See this image and copyright information in PMC

References

    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes. Diabetes Care. 2004;27:1047–1053. doi: 10.2337/diacare.27.5.1047. - DOI - PubMed
    1. Danaei G, Finucane MM, Lu Y, Singh GM, Cowan MJ, Paciorek CJ, Lin JK, Farzadfar F, Khang Y-H, Stevens GA, Rao M, Ali MK, Riley LM, Robinson CA, Ezzati M. Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose) National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet. 2011;378:31–40. doi: 10.1016/S0140-6736(11)60679-X. - DOI - PubMed
    1. Begg SJ, Vos T, Barker B, Stanley L, Lopez AD. Burden of disease and injury in Australia in the new millennium: measuring health loss from diseases, injuries and risk factors. Med J Aust. 2008;188:36–40. - PubMed
    1. Vos T, Goss J, Begg S, Mann M. Projection of health care expenditure by disease: a case study from Australia. Background paper for United Nations 2007 World Economic and Social Survey publication. Brisbane: University of Queensland; 2007.
    1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403. - PMC - PubMed

Publication types