Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial
1 Deakin Health Economics, Population Health Strategic Research Centre, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood VIC 3125, Australia
2 Greater Green Triangle University Department of Rural Health, Flinders University, PO Box 423, Warrnambool VIC 3280, 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, St Albans VIC 3021, Australia
4 Deakin Health Services Implementation Research Unit, Population Health Strategic Research Centre, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood VIC 3125, Australia
5 Diabetes Australia – Victoria, Melbourne, 570 Elizabeth Street, Melbourne VIC 3000, Australia
6 Centre for Physical Activity and Nutrition Research, Faculty of Health, Deakin University, 221 Burwood Highway, Burwood, VIC 3125, Australia
7 South Australia Health, GPO Box 2100, Adelaide SA 5001, Australia
8 Office of the Chief Health Officer, Department of Health, 14/50 Lonsdale Street, Melbourne, VIC 3000, Australia
9 Psychological and Clinical Sciences, Charles Darwin University, Casuarina Campus, Ellengowan Drive, Casuarina, Darwin NT 0909, Australia
10 Melbourne School of Population and Global Health, The University of Melbourne, PO Box 5266, Burnley VIC 3121, Australia
11 Melbourne Medical School, The University of Melbourne, Medical Building, Melbourne VIC 3010, Australia
Trials 2013, 14:339 doi:10.1186/1745-6215-14-339Published: 17 October 2013
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.
Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066