Antenatal lifestyle advice for women who are overweight or obese: LIMIT randomised trialBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1285 (Published 10 February 2014) Cite this as: BMJ 2014;348:g1285
- Jodie M Dodd, professor of obstetrics and gynaecology; maternal fetal medicine specialist12,
- Deborah Turnbull, professor of psychology3,
- Andrew J McPhee, director of neonatal medicine4,
- Andrea R Deussen, senior clinical trials coordinator1,
- Rosalie M Grivell, senior lecturer in obstetrics and gynaecology; maternal fetal medicine specialist12,
- Lisa N Yelland, senior statistician1,
- Caroline A Crowther, professor of obstetrics and gynaecology1,
- Gary Wittert, professor medicine5,
- Julie A Owens, head of school paediatrics and reproductive health; associate dean, research1,
- Jeffrey S Robinson, professor of obstetrics and gynaecology1
- for the LIMIT Randomised Trial Group
- 1Robinson Institute and School of Paediatrics and Reproductive Health, University of Adelaide, 72 King William Road, North Adelaide, South Australia, Australia 5006
- 2Department of Perinatal Medicine, Women’s and Babies Division, Women’s and Children’s Hospital, 72 King William Road, North Adelaide, South Australia, Australia 5006
- 3School of Psychology, University of Adelaide, Adelaide, South Australia, Australia 5005
- 4Department of Neonatal Medicine, Women’s and Babies Division, Women’s and Children’s Hospital, 72 King William Road, North Adelaide, South Australia, Australia 5006
- 5School of Medicine, University of Adelaide, Adelaide, South Australia, AUSTRALIA 5005
- Correspondence to: J M Dodd
- Accepted 24 January 2014
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 2212 women with a singleton pregnancy, between 10+0 and 20+0 weeks’ gestation, and BMI ≥25.
Interventions 1108 women were randomised to a comprehensive dietary and lifestyle intervention delivered by research staff; 1104 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 >4000 g, hypertension, pre-eclampsia, and gestational diabetes. Analyses used intention to treat principles.
Results 2152 women and 2142 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 203/1075 (19%) v 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%) v standard care 201/1067 (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).
We are indebted to all the women who participated in this randomised trial.
The following people and institutions (in Adelaide, South Australia, unless indicated otherwise) participated in the LIMIT Trial:
Steering group—JMD, DT, AMcP, RMG, CAC, M Gillman (Obesity Prevention Program, and Harvard University, Boston, Massachusetts, US), GW, JAO, JSR.
Coordinating team—JMD, ARD, RMG, LNY, L Moran, C Cramp, A Newman, L Kannieappian, S Hendrijanto, M Kelsey, J Beaumont, C Danz, J Koch, A Webber, C Holst, K Robinson, S Zhang, V Ball, K Ball, H Deussen, N Salehi, R Bartley, R Stafford-Green, S Ophel, M Cooney, M Szmeja, A Short, A Melrose, S Han, I Mohamad, L Chapple.
Adverse events committee—RMG, J Svigos, V Bhatia, N Manton.
Collaborating Hospitals (total number of women recruited from each site in parentheses), *indicates named associate investigator for the NHMRC grant.
Flinders Medical Centre (South Australia) (n=669): J McGavigan*, R Bryce, S Coppi, C Fanning, G Hannah, M Ignacio, H Pollard, F Schmidt, Y Shinners
Lyell McEwin Hospital (South Australia) (n=505): G Dekker*, S Kennedy-Andrews, R Beaven, J Niven, S Burgen, J Dalton, N Dewhurst, L Forst, V Mugg, C Will, H Stone
Women’s and Children’s Hospital (South Australia) (n=1038): JMD, JSR, ARD, CAC*, C Wilkinson*, H Purcell, J Wood, D Press, K Ralph, S Donleavy, S Seager, F Gately, A Jolly, L Lahnstein, S Harding, K Daw, M Hedges, R Fraser-Trumble
Contributors: All authors were involved equally in the development and design of the trial, the conduct of the trial, drafting of the manuscript, and revision for intellectual content and approved the final submitted version. LNY carried out the statistical analyses. JMD is guarantor.
Funding: This project was funded by a four year project grant from the National Health and Medical Research Council (NHMRC), Australia (ID 519240). JMD is supported through a NHMRC Practitioner Fellowship (ID 627005). The funder had no role in the study design, data collection, analysis, interpretation, or writing of the report.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by each of the collaborating sites (Research Secretariat, Women’s and Children’s Hospital (application REC 1839/6/2012); Ethics of Human Research Committee, The Queen Elizabeth Hospital and Lyell McEwin Hospital (application 2008033); and Flinders Clinical Research Ethics Committee, Flinders Medical Centre (Application 128/08)). Each participant provided written informed consent,
Data sharing: No additional data available.
Transparency: The lead author and manuscript guarantor (JMD) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.
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