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Open Access Update

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial

Sophy TF Shih1, Nathalie Davis-Lameloise2, Edward D Janus23, Carol Wildey24, Vincent L Versace2, Virginia Hagger5, Dino Asproloupos24, Sharleen L O’Reilly6, Paddy A Phillips78, Michael Ackland9, Timothy Skinner10, Jeremy Oats11, Rob Carter1, James D Best12, James A Dunbar2* and On behalf of the MAGDA Research Group

Author Affiliations

1 Deakin Health Economics, Population Health Strategic Research Centre, Faculty of Health, Deakin University, 221 Burwood Highway, 3125 Burwood, VIC, Australia

2 Greater Green Triangle University Department of Rural Health, Flinders University, PO Box 423, 3280 Warrnambool, VIC, Australia

3 Department of Medicine, North West Academic Centre, The University of Melbourne, Western Centre for Health Research and Education, Western Health, 176 Furlong Rd, 3021 St Albans, VIC, Australia

4 Deakin Health Services Implementation Research Unit, Population Health Strategic Research Centre, Faculty of Health, Deakin University, 221 Burwood Highway, 3125 Burwood, VIC, Australia

5 Diabetes Australia – Victoria, Melbourne, 570 Elizabeth Street, 3000 Melbourne, VIC, Australia

6 Centre for Physical Activity and Nutrition Research, Faculty of Health, Deakin University, 221 Burwood Highway, 3125 Burwood, VIC, Australia

7 South Australia Health, GPO Box 2100, 5001 Adelaide, SA, Australia

8 Department of Medicine, Flinders University, GPO Box 2100, 5001 Adelaide, SA, Australia

9 Office of the Chief Health Officer, Department of Health, 14/50 Lonsdale Street, 3000 Melbourne, VIC, Australia

10 Psychological and Clinical Sciences, Charles Darwin University, Casuarina Campus, Ellengowan Drive, Casuarina, 0909 Darwin, NT, Australia

11 Melbourne School of Population and Global Health, The University of Melbourne, PO Box 5266, 3121 Burnley, VIC, Australia

12 Melbourne Medical School, Level 2 West Wing, Medical Building (181), 3010 The University of Melbourne, Melbourne, VIC, Australia

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Trials 2014, 15:259  doi:10.1186/1745-6215-15-259

Published: 30 June 2014

Abstract

Background

The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes.

Methods/Design

The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339 webcite). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion “surgical or medical intervention to treat obesity” has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy.

Trial registration

Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

Keywords:
Gestational diabetes; Lifestyle intervention; Post-natal; Type 2 diabetes prevention