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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.
authors.forename: Sophy T F
authors.initials: ST
authors.lastname: Shih
authors.forename: Nathalie
authors.initials: N
authors.lastname: Davis-Lameloise
authors.forename: Edward D
authors.initials: ED
authors.lastname: Janus
authors.forename: Carol
authors.initials: C
authors.lastname: Wildey
authors.forename: Vincent L
authors.initials: VL
authors.lastname: Versace
authors.forename: Virginia
authors.initials: V
authors.lastname: Hagger
authors.forename: Dino
authors.initials: D
authors.lastname: Asproloupos
authors.forename: Sharleen
authors.initials: S
authors.lastname: O'Reilly
authors.forename: Paddy A
authors.initials: PA
authors.lastname: Phillips
authors.forename: Michael
authors.initials: M
authors.lastname: Ackland
authors.forename: Timothy
authors.initials: T
authors.lastname: Skinner
authors.forename: Jeremy
authors.initials: J
authors.lastname: Oats
authors.forename: Rob
authors.initials: R
authors.lastname: Carter
authors.forename: James D
authors.initials: JD
authors.lastname: Best
authors.affiliation: Greater Green Triangle University Department of Rural Health, Flinders University, PO Box 423, Warrnambool VIC 3280, Australia. director@greaterhealth.org.
authors.forename: James A
authors.initials: JA
authors.lastname: Dunbar
mesh_terms: D001315:Australia; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D016640:Diabetes, Gestational / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006801:Humans; D011181:Postnatal Care / Q000379:methods*; D011247:Pregnancy; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome