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Background  Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity.    Methods  The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m 2  recruited from gynaecological and midwifery practices prior to the end of the 12 th  week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided.    Results  The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66–1.38,  p  = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively ( p  = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g,  p  = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm,  p  = 0.001).    Conclusion  In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed.    Trial registration   NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.    Electronic supplementary material  The online version of this article (10.1186/s12916-018-1235-z) contains supplementary material, which is available to authorized users.

Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care – the cluster-randomised GeliS trial