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 Shih, Nathalie Davis-Lameloise, Edward Janus, Carol Wildey, Vincent Versace, Virginia Hagger, Dino Asproloupos, Sharleen O'Reilly, Paddy Phillips, Michael Ackland, Timothy Skinner, Jeremy Oats, Rob Carter, James Best, James Dunbar

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    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. 
    Original languageEnglish
    Pages (from-to)1-2
    Number of pages2
    JournalTrials
    Volume15
    DOIs
    Publication statusPublished - 30 Jun 2014

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    Shih, S., Davis-Lameloise, N., Janus, E., Wildey, C., Versace, V., Hagger, V., Asproloupos, D., O'Reilly, S., Phillips, P., Ackland, M., Skinner, T., Oats, J., Carter, R., Best, J., & Dunbar, J. (2014). 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. Trials, 15, 1-2. https://doi.org/10.1186/1745-6215-15-259