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dc.contributor.authorDodd, Jodie M
dc.contributor.authorGrivell, Rosalie M
dc.contributor.authorDeussen, Andrea R
dc.contributor.authorDekker, Gustaaf
dc.contributor.authorLouise, Jennie
dc.contributor.authorHague, William
dc.date.accessioned2017-04-04T02:41:18Z
dc.date.available2017-04-04T02:41:18Z
dc.date.issued2016-11-21
dc.identifier.citationDodd, J. M., Grivell, R. R., Deussen, A., Dekker, G., Hague, W., & Louise, J. (2016). Metformin and dietary advice to improve insulin sensitivity and promote gestational restriction of weight among pregnant women who are overweight or obese: The GRoW Randomised Trial. BMC Pregnancy and Childbirth, 16(1),en
dc.identifier.issn1471-2393
dc.identifier.urihttp://hdl.handle.net/2328/37067
dc.descriptionThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.description.abstractBackground Obesity is a significant global health problem, with approximately 50% of women entering pregnancy having a body mass index greater than or equal to 25 kg/m2. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant. Currently available data from large scale randomised trials and systematic reviews highlight only modest effects of antenatal dietary and lifestyle interventions in limiting gestational weight gain, with little impact on clinically relevant pregnancy outcomes. Further information evaluating alternative strategies is required. The aims of this randomised controlled trial are to assess whether the use of metformin as an adjunct therapy to dietary and lifestyle advice for overweight and obese women during pregnancy is effective in improving maternal, fetal and infant health outcomes. Methods Design: Multicentre randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using an online computer randomisation system, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Metformin Group will receive a supply of 500 mg oral metformin tablets. Women randomised to the Placebo Group will receive a supply of identical appearing and tasting placebo tablets. Women will be instructed to commence taking one tablet daily for a period of one week, increasing to a maximum of two tablets twice daily over four weeks and then continuing until birth. Women, clinicians, researchers and outcome assessors will be blinded to the allocated treatment group. All women will receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant), and three telephone calls over the course of their pregnancy, in which they will be provided with dietary and lifestyle advice, and encouraged to make change utilising a SMART goals approach. Primary Study Outcome: infant birth weight >4000 grams. Sample Size: 524 women to detect a difference from 15.5% to 7.35% reduction in infants with birth weight >4000 grams (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines.en
dc.language.isoen
dc.publisherBioMed Centralen
dc.relationhttp://purl.org/au-research/grants/nhmrc/1043181en
dc.rights© The Author(s). 2016en
dc.subjectinsulin sensitivityen
dc.subjectpregnancyen
dc.subjectpregnanten
dc.subjectoverweight or obeseen
dc.subjectGRoW Randomised Trialen
dc.subjectObesity during pregnancyen
dc.titleMetformin and dietary advice to improve insulin sensitivity and promote gestational restriction of weight among pregnant women who are overweight or obese: the GRoW Randomised Trialen
dc.typeArticleen
dc.relation.grantnumberNHMRC/1043181en
dc.identifier.doihttps://doi.org/10.1186/s12884-016-1161-zen
dc.rights.holderThe Author(s).en
dc.rights.licenseCC-BY
local.contributor.authorOrcidLookupGrivell, Rosalie M: https://orcid.org/0000-0002-2447-6519en_US


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