Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/18012
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dc.contributor.authorPrice, Sarah A-
dc.contributor.authorNankervis, Alison-
dc.contributor.authorPermezel, Michael-
dc.contributor.authorPrendergast, Luke-
dc.contributor.authorSumithran, Priya-
dc.contributor.authorProietto, Joseph-
dc.date2018-04-24-
dc.date.accessioned2018-07-05T06:40:09Z-
dc.date.available2018-07-05T06:40:09Z-
dc.date.issued2018-04-24-
dc.identifier.citationTrials 2018; 19(1): 248en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/18012-
dc.description.abstractCurrent guidelines for the management of obesity in women planning pregnancy suggest lifestyle modification before conception. However, there is little evidence that lifestyle modification alters pregnancy outcomes. Bariatric surgery results in significant weight loss. This appears to reduce the risk of adverse pregnancy outcomes for the mother but may increase the risk of adverse outcomes for the infant. In order to reduce the risks of obesity-related adverse pregnancy outcomes for both mother and offspring, alternative approaches to the management of obesity in women planning pregnancy are needed. This study, a two-arm, parallel group, randomized control trial, will be conducted at the Metabolic Disorders Centre, University of Melbourne. This trial will recruit 164 women aged 18-38 years with a body mass index of 30-55 kg/m2 who plan to conceive in the next 6-12 months. Women will be randomized to one of two 12-week interventions (Group A and Group B). Group A will aim for modest weight loss (MWL; ≤ 3% body weight) using a hypocaloric diet. Group B will aim for substantial weight loss (SWL; 10-15% body weight) using a modified very low energy diet (VLED) program. All participants will be asked to comply with National Health and Medical Research Council (NHMRC) guidelines for exercise and will be provided with standard pre-pregnancy advice according to Royal Australian and New Zealand College of Obstetrics and Gynaecology guidelines. All participants will then be observed for the subsequent 12 months. If pregnancy occurs within the 12-month follow-up period, data on weight and metabolic status of the mother, and pregnancy outcomes of mother and offspring will be recorded. The primary outcome is maternal fasting plasma glucose at 26-28 weeks' gestation, given that this is known to correlate with pregnancy outcomes. Time to conception, live birth rate, gestational weight gain, and a composite of adverse pregnancy outcomes for mother and baby will comprise the secondary outcomes. There is increasing emphasis on obese women losing weight before conception. To date, no randomized controlled trial has demonstrated an effective means of weight loss that results in improved pregnancy outcomes for both mother and baby. This study intends to determine if substantial pre-conception weight loss, achieved using a VLED, improves pregnancy outcomes for mother and baby when compared with standard care. This research will potentially change clinical care of an obese woman planning pregnancy. ANZCTR, 12,614,001,160,628 . Registered on 5 November 2014.en_US
dc.language.isoeng-
dc.subjectGlucose metabolismen_US
dc.subjectObesityen_US
dc.subjectPre-conceptionen_US
dc.subjectPregnancyen_US
dc.subjectPregnancy outcomesen_US
dc.subjectRandomized trialen_US
dc.subjectWeight lossen_US
dc.titleHealth consequences for mother and baby of substantial pre-conception weight loss in obese women: study protocol for a randomized controlled trial.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleTrialsen_US
dc.identifier.affiliationDiabetes Service, University of Melbourne, Royal Women's Hospital, Flemington Rd., Parkville, VIC, Australiaen_US
dc.identifier.affiliationDepartment of Medicine, University of Melbourne, Royal Melbourne Hospital, Grattan St.,, Parkville, VIC, Australiaen_US
dc.identifier.affiliationDepartment of Obstetrics and Gynaecology, Mercy Hospital for Women, The University of Melbourne, Heidelberg, Victoria, Australiaen_US
dc.identifier.affiliationDepartment of Mathematics and Statistics, LaTrobe University, Kingsbury Drive, Bundoora, VIC, Australiaen_US
dc.identifier.affiliationMedicine (University of Melbourne)en_US
dc.identifier.doi10.1186/s13063-018-2615-6en_US
dc.type.contentTexten_US
dc.identifier.orcid0000-0001-7722-3171en_US
dc.identifier.pubmedid29690917-
dc.type.austinJournal Article-
local.name.researcherPrice, Sarah A
item.openairetypeJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.grantfulltextnone-
item.fulltextNo Fulltext-
item.cerifentitytypePublications-
item.languageiso639-1en-
crisitem.author.deptEndocrinology-
crisitem.author.deptMedicine (University of Melbourne)-
crisitem.author.deptEndocrinology-
crisitem.author.deptMedicine (University of Melbourne)-
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