PMID- 24135085 OWN - NLM STAT- MEDLINE DCOM- 20140902 LR - 20211021 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 14 DP - 2013 Oct 17 TI - Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial. PG - 339 LID - 10.1186/1745-6215-14-339 [doi] AB - BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066. FAU - Shih, Sophy T F AU - Shih ST FAU - Davis-Lameloise, Nathalie AU - Davis-Lameloise N FAU - Janus, Edward D AU - Janus ED FAU - Wildey, Carol AU - Wildey C FAU - Versace, Vincent L AU - Versace VL FAU - Hagger, Virginia AU - Hagger V FAU - Asproloupos, Dino AU - Asproloupos D FAU - O'Reilly, Sharleen AU - O'Reilly S FAU - Phillips, Paddy A AU - Phillips PA FAU - Ackland, Michael AU - Ackland M FAU - Skinner, Timothy AU - Skinner T FAU - Oats, Jeremy AU - Oats J FAU - Carter, Rob AU - Carter R FAU - Best, James D AU - Best JD FAU - Dunbar, James A AU - Dunbar JA AD - Greater Green Triangle University Department of Rural Health, Flinders University, PO Box 423, Warrnambool VIC 3280, Australia. director@greaterhealth.org. CN - MAGDA Research Group LA - eng SI - ANZCTR/ANZCTRN1261000033806 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20131017 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Australia MH - Clinical Protocols MH - Diabetes Mellitus, Type 2/diagnosis/etiology/*prevention & control MH - Diabetes, Gestational/diagnosis/*therapy MH - Female MH - Humans MH - Postnatal Care/*methods MH - Pregnancy MH - Prospective Studies MH - *Research Design MH - Risk Factors MH - *Risk Reduction Behavior MH - Time Factors MH - Treatment Outcome PMC - PMC3853589 EDAT- 2013/10/19 06:00 MHDA- 2014/09/03 06:00 PMCR- 2013/10/17 CRDT- 2013/10/19 06:00 PHST- 2013/07/29 00:00 [received] PHST- 2013/09/26 00:00 [accepted] PHST- 2013/10/19 06:00 [entrez] PHST- 2013/10/19 06:00 [pubmed] PHST- 2014/09/03 06:00 [medline] PHST- 2013/10/17 00:00 [pmc-release] AID - 1745-6215-14-339 [pii] AID - 10.1186/1745-6215-14-339 [doi] PST - epublish SO - Trials. 2013 Oct 17;14:339. doi: 10.1186/1745-6215-14-339.