Double-blind RCT of fish oil supplementation in pregnancy and lactation to improve the metabolic health in children of mothers with overweight or obesity during pregnancy: study protocol

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dc.citation.issue12
dc.citation.volume10
dc.contributor.authorSatokar VV
dc.contributor.authorCutfield WS
dc.contributor.authorDerraik JGB
dc.contributor.authorHarwood M
dc.contributor.authorOkasene-Gafa K
dc.contributor.authorBeck K
dc.contributor.authorCameron-Smith D
dc.contributor.authorO'Sullivan JM
dc.contributor.authorSundborn G
dc.contributor.authorPundir S
dc.contributor.authorMason RP
dc.contributor.authorAlbert BB
dc.coverage.spatialEngland
dc.date.accessioned2023-08-28T03:21:04Z
dc.date.accessioned2023-09-04T01:41:29Z
dc.date.available2020-12-15
dc.date.available2023-08-28T03:21:04Z
dc.date.available2023-09-04T01:41:29Z
dc.date.issued2020-12-15
dc.date.updated2023-08-18T01:38:50Z
dc.description© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.en_US
dc.description.abstractIntroduction Maternal obesity during pregnancy is associated with adverse changes in body composition and metabolism in the offspring. We hypothesise that supplementation during pregnancy of overweight and obese women may help prevent the development of greater adiposity and metabolic dysfunction in children. Previous clinical trials investigating fish oil supplementation in pregnancy on metabolic outcomes and body composition of the children have not focused on the pregnancies of overweight or obese women. Methods and analysis A double-blind randomised controlled trial of fish oil (providing 3 g/day of n-3 polyunsaturated fatty acids) versus an equal volume of olive oil (control) taken daily from recruitment until birth, and in breastfeeding mothers, further continued for 3 months post partum. Eligible women will have a singleton pregnancy at 12–20 weeks’ gestation and be aged 18–40 years with body mass index ≥25 kg/m2 at baseline. We aim to recruit a minimum of 128 participants to be randomised 1:1. Clinical assessments will be performed at baseline and 30 weeks of pregnancy, including anthropometric measurements, fasting metabolic markers, measures of anxiety, physical activity, quality of life and dietary intake. Subsequent assessments will be performed when the infant is 2 weeks, 3 months and 12 months of age for anthropometry, body composition (dual-energy X-ray absorptiometry (DXA)) and blood sampling. The primary outcome of the study is a between-group difference in infant percentage body fatness, assessed by DXA, at 2 weeks of age. Secondary outcomes will include differences in anthropometric measures at each time point, percentage body fat at 3 and 12 months and homeostatic model assessment of insulin resistance at 3 months. Statistical analysis will be carried out on the principle of intention to treat. Ethics and dissemination This trial was approved by the Northern A Health and Disabilities Ethics Committee, New Zealand Ministry of Health (17/NTA/154). Results will be published in a peer-reviewed journal. Trial registration number ACTRN12617001078347p; Pre-results.
dc.format.extente041015-
dc.identifierbmjopen-2020-041015
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/33323442
dc.identifier.citationSatokar VV, Cutfield WS, Derraik JGB, Harwood M, Okasene-Gafa K, Beck K, Cameron-Smith D, O'Sullivan JM, Sundborn G, Pundir S, Mason RP, Albert BB. (2020). Double-blind RCT of fish oil supplementation in pregnancy and lactation to improve the metabolic health in children of mothers with overweight or obesity during pregnancy: study protocol.. BMJ Open. 10. 12. (pp. e041015-).
dc.identifier.doi10.1136/bmjopen-2020-041015
dc.identifier.eissn2044-6055
dc.identifier.elements-typejournal-article
dc.identifier.harvestedMassey_Dark
dc.identifier.issn2044-6055
dc.identifier.urihttp://hdl.handle.net/10179/19975
dc.languageeng
dc.publisherBMJ Publishing Group Ltd
dc.relation.isPartOfBMJ Open
dc.rightsCC BY-NCen_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en_US
dc.subjectnutrition & dietetics
dc.subjectobstetrics
dc.subjectpaediatrics
dc.subjectpreventive medicine
dc.subjectAdolescent
dc.subjectAdult
dc.subjectBreast Feeding
dc.subjectChild
dc.subjectDietary Supplements
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectFish Oils
dc.subjectHumans
dc.subjectInfant
dc.subjectLactation
dc.subjectMothers
dc.subjectNew Zealand
dc.subjectObesity
dc.subjectOverweight
dc.subjectPregnancy
dc.subjectQuality of Life
dc.subjectRandomized Controlled Trials as Topic
dc.subjectYoung Adult
dc.titleDouble-blind RCT of fish oil supplementation in pregnancy and lactation to improve the metabolic health in children of mothers with overweight or obesity during pregnancy: study protocol
dc.typeJournal article
pubs.elements-id441217
pubs.organisational-groupOther
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