prevention of gestational diabetes design of a cluster-randomized controlled trial and one-year follow-up预防妊娠糖尿病集群随机对照试验设计和为期一年的随访.pdfVIP

Luoto et al. BMC Pregnancy and Childbirth 2010, 10:39 /1471-2393/10/39 STUDY PROTOCOL Open Access Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up 1,2* 3 1 1 1 1 Riitta M Luoto , Tarja I Kinnunen , Minna Aittasalo , Katriina Ojala , Kirsi Mansikkamäki , Erja Toropainen , Päivi Kolu1, Tommi Vasankari1,2 Abstract Background: Annual prevalence of gestational diabetes mellitus (GDM) is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design: A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/ 2 m , history of earlier gestational glucose intolerance or macrosomic newborn ( 4500 g), age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT) at 8-12 weeks gestation. The trial included one counseling session on physical activity at 8- 12 weeks gestation and one for diet at 16-18 weeks gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on h