Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: 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 O'Reilly; Paddy A. Phillips; Michael Ackland; Timothy Skinner; Jeremy Oats; Rob Carter; James D. Best; James A. Dunbar

doi:10.1186/1745-6215-14-339

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: 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 O'Reilly, Paddy A. Phillips, Michael Ackland, Timothy Skinner, Jeremy Oats, Rob Carter, James D. Best, James A. Dunbar^*

^*Corresponding author for this work

19 Citations (Scopus)

Abstract

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.

Original language	English
Article number	339
Journal	Trials
Volume	14
Issue number	1
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-14-339
Publication status	Published - 17 Oct 2013

Keywords

Gestational diabetes
Lifestyle intervention
Post-natal
Type 2 diabetes prevention

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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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., Phillips, P. A., Ackland, M., Skinner, T., Oats, J., Carter, R., Best, J. D., & Dunbar, J. A. (2013). Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: Study protocol for a randomized controlled trial. Trials, 14(1), [339]. https://doi.org/10.1186/1745-6215-14-339

Shih, STF, Davis-Lameloise, N, Janus, ED, Wildey, C, Versace, VL, Hagger, V, Asproloupos, D, O'Reilly, S, Phillips, PA, Ackland, M, Skinner, T, Oats, J, Carter, R, Best, JD & Dunbar, JA 2013, 'Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: Study protocol for a randomized controlled trial', Trials, vol. 14, no. 1, 339. https://doi.org/10.1186/1745-6215-14-339

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title = "Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: Study protocol for a randomized controlled trial",

abstract = "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.",

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

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doi = "10.1186/1745-6215-14-339",

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T1 - Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention

T2 - Study protocol for a randomized controlled trial

AU - Shih, Sophy T.F.

AU - Davis-Lameloise, Nathalie

AU - Janus, Edward D.

AU - Wildey, Carol

AU - Versace, Vincent L.

AU - Hagger, Virginia

AU - Asproloupos, Dino

AU - O'Reilly, Sharleen

AU - Phillips, Paddy A.

AU - Ackland, Michael

AU - Skinner, Timothy

AU - Oats, Jeremy

AU - Carter, Rob

AU - Best, James D.

AU - Dunbar, James A.

PY - 2013/10/17

Y1 - 2013/10/17

N2 - 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.

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.

KW - Gestational diabetes

KW - Lifestyle intervention

KW - Post-natal

KW - Type 2 diabetes prevention

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SN - 1745-6215

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ER -

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: Study protocol for a randomized controlled trial

Abstract

Keywords

UN SDGs

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