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
Introduction 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...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/12/e041015.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846160764895756288 |
|---|---|
| author | Matire Harwood José G B Derraik Wayne S Cutfield Benjamin B Albert Justin M O’Sullivan Gerhard Sundborn Kathryn Beck Vidit V Satokar Karaponi Okasene-Gafa David Cameron-Smith Shikha Pundir R Preston Mason |
| author_facet | Matire Harwood José G B Derraik Wayne S Cutfield Benjamin B Albert Justin M O’Sullivan Gerhard Sundborn Kathryn Beck Vidit V Satokar Karaponi Okasene-Gafa David Cameron-Smith Shikha Pundir R Preston Mason |
| author_sort | Matire Harwood |
| collection | DOAJ |
| description | Introduction 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. |
| format | Article |
| id | doaj-art-693ffaf09cf8420ea897cfd539bd48e3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-693ffaf09cf8420ea897cfd539bd48e32024-11-21T22:50:07ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-041015Double-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 protocolMatire Harwood0José G B Derraik1Wayne S Cutfield2Benjamin B Albert3Justin M O’Sullivan4Gerhard Sundborn5Kathryn Beck6Vidit V Satokar7Karaponi Okasene-Gafa8David Cameron-Smith9Shikha Pundir10R Preston Mason11School of Population Health, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New ZealandDepartment of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New ZealandA Better Start - National Science Challenge, University of Auckland, Auckland, New ZealandLiggins Institute, The University of Auckland, Auckland, New ZealandLiggins Institute, University of Auckland, Auckland, New ZealandSection of Pacific Health, the University of Auckland, Auckland, New ZealandSchool of Sport Exercise and Nutrition, Massey University, Auckland, New ZealandLiggins Institute, University of Auckland, Auckland, New ZealandDepartment of Obstetrics and Gynaecology, University of Auckland, Auckland, New ZealandLiggins Institute, University of Auckland, Auckland, New ZealandLiggins Institute, University of Auckland, Auckland, New ZealandBrigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USAIntroduction 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.https://bmjopen.bmj.com/content/10/12/e041015.full |
| spellingShingle | Matire Harwood José G B Derraik Wayne S Cutfield Benjamin B Albert Justin M O’Sullivan Gerhard Sundborn Kathryn Beck Vidit V Satokar Karaponi Okasene-Gafa David Cameron-Smith Shikha Pundir R Preston Mason 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/12/e041015.full |
| work_keys_str_mv | AT matireharwood doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT josegbderraik doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT waynescutfield doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT benjaminbalbert doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT justinmosullivan doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT gerhardsundborn doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT kathrynbeck doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT viditvsatokar doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT karaponiokasenegafa doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT davidcameronsmith doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT shikhapundir doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol AT rprestonmason doubleblindrctoffishoilsupplementationinpregnancyandlactationtoimprovethemetabolichealthinchildrenofmotherswithoverweightorobesityduringpregnancystudyprotocol |