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Main outcome measures Incidence of infants born large for gestational age (birth weight ≥90th centile for gestation and sex).Prespecified secondary outcomes included birth weight 4000 g, hypertension, pre-eclampsia, and gestational diabetes. Results 2152 women and 2142 liveborn infants were included in the analyses.Objective To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women. We utilised a central telephone randomisation server, with computer generated schedule, balanced variable blocks, and stratification for parity, body mass index (BMI) category, and hospital.Setting Three public maternity hospitals across South Australia.Both unadjusted and adjusted analyses were performed, with adjustment for the stratification variables.Outcomes derived from birth weight were additionally adjusted for maternal age, socioeconomic status, and maternal smoking. A total of 2152 women and 2142 liveborn infants were included in the intention to treat analyses.The risk of the infant being large for gestational age was not significantly different in the two groups (lifestyle advice 203/1075 (19%) standard care 224/1067 (21%); adjusted relative risk 0.90, 95% confidence interval 0.77 to 1.07; P=0.24).Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g (lifestyle advice 164/1075 (15%) standard care 201/1067 (19%); 0.82, 0.68 to 0.99; number needed to treat (NNT) 28, 15 to 263; P=0.04).

Women randomised to standard care continued to receive their pregnancy care according to state-wide perinatal practice and local hospital guidelines, which during the course of the trial did not include routine provision of advice related to diet, exercise, or gestational weight gain.24All women had their ongoing clinical care provided by clinicians at their planned hospital of birth.

Each participant provided written informed consent, and the ethics committee at each collaborating hospital approved the protocol.20All pregnant women presenting for antenatal care at the participating centres had their height and weight measured and BMI calculated at their first antenatal appointment.

A research assistant counselled eligible women and then randomised them to receive lifestyle advice or standard care by telephoning the central randomisation service.

There were two maternal deaths (motor vehicle collision in lifestyle advice group; and ruptured maternal splenic artery aneurysm in standard care group).

There were 10 stillborn infants (two from placental abruption, one from severe intrauterine growth restriction, one from acute chorioamnionitis, and one from motor vehicle collision in lifestyle advice group; and two from placental insufficiency, one from obstetric cholestasis, and two unexplained in standard care group) and two neonatal deaths (excluding lethal congenital anomalies) from complications of extreme prematurity, one in each group.

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