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 T F Shih; Nathalie Davis-Lameloise; Edward D. Janus; Carol Wildey; Vincent L. Versace; Virginia Hagger; Dino Asproloupos; Sharleen L. O'Reilly; Paddy A. Phillips; Michael Ackland; Timothy Skinner; Jeremy Oats; Rob Carter; James D. Best; James A. Dunbar

doi:10.1186/1745-6215-15-259

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 T F Shih, Nathalie Davis-Lameloise, Edward D. Janus, Carol Wildey, Vincent L. Versace, Virginia Hagger, Dino Asproloupos, Sharleen L. O'Reilly, Paddy A. Phillips, Michael Ackland, Timothy Skinner, Jeremy Oats, Rob Carter, James D. Best, James A. Dunbar^*

^*Corresponding author af dette arbejde

8 Citationer (Scopus)

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). 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.

Originalsprog	Engelsk
Artikelnummer	259
Tidsskrift	Trials
Vol/bind	15
Udgave nummer	1
ISSN	1745-6215
DOI	https://doi.org/10.1186/1745-6215-15-259
Status	Udgivet - 30 jun. 2014

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10.1186/1745-6215-15-259Licens: CC BY

1745-6215-15-259Forlagets udgivne version, 244 KBLicens: CC BY

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

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. / Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D. et al.

I: Trials, Bind 15, Nr. 1, 259, 30.06.2014.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Shih, STF, Davis-Lameloise, N, Janus, ED, Wildey, C, Versace, VL, Hagger, V, Asproloupos, D, O'Reilly, SL, Phillips, PA, Ackland, M, Skinner, T, Oats, J, Carter, R, Best, JD & Dunbar, JA 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, bind 15, nr. 1, 259. https://doi.org/10.1186/1745-6215-15-259

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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). 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.",

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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

Abstract

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