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
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
Trials 2014, 15:259 doi:10.1186/1745-6215-15-259Published: 30 June 2014
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.
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.
Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.