title: A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes.
abstract: BACKGROUND
  There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group's (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier's shared care (SC) on pregnancy outcomes of GDM.
  
  
  METHODS
  Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 (interquartile range: 25.4-27.3) gestational weeks in Tianjin, China, to receive SC or usual care (UC). The SC group received individual consultations and group sessions and performed regular self-monitoring of blood glucose compared to one hospital-based education session in the UC group. The outcomes were macrosomia defined as birth weight ≥ 4.0 kg and the pregnancy-induced hypertension (PIH).
  
  
  RESULTS
  Women in the SC (n = 339) and UC (n = 361) groups delivered their infants at similar gestational weeks. Birth weight of infants in the SC group was lower than that in the UC group (3469 vs. 3371 grams, P = 0.021). The rate of macrosomia was 11.2% (38/339) in the SC group compared to 17.5% (63/361) in the UC group with relative risk (RR) of 0.64 (95% CI: 0.44-0.93). The rate of PIH was 8.0% (27/339) in the SC compared to 4.4% (16/361) in the UC with RR of 1.80 (0.99-3.28). Apgar score at 1 min < 7 was lower but preeclampsia was higher in the SC than in the UC.
  
  
  CONCLUSIONS
  Lifestyle modifications using a SC system improved pregnancy outcomes in Chinese women with GDM.
  
  
  BACKGROUND
  Clinicaltrials.gov; NCT01565564.
authors.forename: Xilin
authors.initials: X
authors.lastname: Yang
authors.forename: Huiguang
authors.initials: H
authors.lastname: Tian
authors.forename: Fuxia
authors.initials: F
authors.lastname: Zhang
authors.forename: Cuiping
authors.initials: C
authors.lastname: Zhang
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.forename: Junhong
authors.initials: J
authors.lastname: Leng
authors.forename: Leishen
authors.initials: L
authors.lastname: Wang
authors.forename: Gongshu
authors.initials: G
authors.lastname: Liu
authors.forename: Gongsu
authors.initials: G
authors.lastname: Liu
authors.forename: Ling
authors.initials: L
authors.lastname: Dong
authors.forename: Zhijie
authors.initials: Z
authors.lastname: Yu
authors.forename: Gang
authors.initials: G
authors.lastname: Hu
authors.forename: Juliana Cn
authors.initials: JC
authors.lastname: Chan
mesh_terms: D000328:Adult; D002681:China; D016640:Diabetes, Gestational / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008019:Life Style; D011247:Pregnancy; D011256:Pregnancy Outcome; D057170:Translational Research, Biomedical