TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=84885526809&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-14-339
DO - 10.1186/1745-6215-14-339
M3 - Journal article
C2 - 24135085
AN - SCOPUS:84885526809
SN - 1745-6215
VL - 14
JO - Trials
JF - Trials
IS - 1
M1 - 339
ER -
