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Antenatal lifestyle advice for women who are overweight or obese: LIMIT randomised trial [with consumer summary]
Dodd JM, Turnbull D, McPhee AJ, Deussen AR, Grivell RM, Yelland LN, Crowther CA, Wittert G, Owens JA, Robinson JS, for the LIMIT Randomised Trial Group
BMJ 2014 Feb 10;348:g1285
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women. DESIGN: Multicentre randomised trial. 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. PARTICIPANTS: 2,212 women with a singleton pregnancy, between 10+0 and 20+0 weeks' gestation, and BMI >= 25. INTERVENTIONS: 1,108 women were randomised to a comprehensive dietary and lifestyle intervention delivered by research staff; 1,104 were randomised to standard care and received pregnancy care according to local guidelines, which did not include such information. 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 > 4,000 g, hypertension, pre-eclampsia, and gestational diabetes. Analyses used intention to treat principles. RESULTS: 2,152 women and 2,142 liveborn infants were included in the analyses. The risk of the infant being large for gestational age was not significantly different in the two groups (lifestyle advice 203/1,075 (19%) versus standard care 224/1,067 (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 4,000 g (lifestyle advice 164/1,075 (15%) versus standard care 201/1,067 (19%); 0.82, 0.68 to 0.99; number needed to treat (NNT) 28, 15 to 263; p = 0.04). There were no differences in maternal pregnancy and birth outcomes between the two treatment groups. CONCLUSIONS: For women who were overweight or obese, the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN12607000161426).
Reproduced with permission from the BMJ Publishing Group.

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