Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial

Background Pregnant women with metabolic risk factors are at high risk of complications. We aimed to assess whether a Mediterranean-style diet reduces adverse pregnancy outcomes in high-risk women. Methods and findings We conducted a multicentre randomised trial in 5 maternity units (4 in Londo...

Full description

Bibliographic Details
Main Authors: Al-Wattar, B.H. (Bassel H.), Dodds, J. (Julie), Placzek, A. (Anna), Beresford, L. (Lee), Spyreli, E. (Eleni), Moore, A. (Amanda), González-Carreras, F.J. (Francisco J.), Austin, F. (Frances), Murugesu, N. (Nilaani), Roseboom, T.J. (Tessa J.), Bes-Rastrollo, M. (Maira), Hitman, G. (Graham), Hooper, R. (Richard), Khan, K.S. (Khalid S.), Thangaratinam, S. (Shakila)
Format: info:eu-repo/semantics/article
Language:eng
Published: Public Library of Science (PLoS) 2022
Subjects:
Online Access:https://hdl.handle.net/10171/63702
_version_ 1793400089135284224
author Al-Wattar, B.H. (Bassel H.)
Dodds, J. (Julie)
Placzek, A. (Anna)
Beresford, L. (Lee)
Spyreli, E. (Eleni)
Moore, A. (Amanda)
González-Carreras, F.J. (Francisco J.)
Austin, F. (Frances)
Murugesu, N. (Nilaani)
Roseboom, T.J. (Tessa J.)
Bes-Rastrollo, M. (Maira)
Hitman, G. (Graham)
Hooper, R. (Richard)
Khan, K.S. (Khalid S.)
Thangaratinam, S. (Shakila)
author_facet Al-Wattar, B.H. (Bassel H.)
Dodds, J. (Julie)
Placzek, A. (Anna)
Beresford, L. (Lee)
Spyreli, E. (Eleni)
Moore, A. (Amanda)
González-Carreras, F.J. (Francisco J.)
Austin, F. (Frances)
Murugesu, N. (Nilaani)
Roseboom, T.J. (Tessa J.)
Bes-Rastrollo, M. (Maira)
Hitman, G. (Graham)
Hooper, R. (Richard)
Khan, K.S. (Khalid S.)
Thangaratinam, S. (Shakila)
author_sort Al-Wattar, B.H. (Bassel H.)
collection DSpace
description Background Pregnant women with metabolic risk factors are at high risk of complications. We aimed to assess whether a Mediterranean-style diet reduces adverse pregnancy outcomes in high-risk women. Methods and findings We conducted a multicentre randomised trial in 5 maternity units (4 in London and 1 in Birmingham) between 12 September 2014 and 29 February 2016. We randomised inner-city pregnant women with metabolic risk factors (obesity, chronic hypertension, or hypertriglyceridaemia) to a Mediterranean-style diet with high intake of nuts, extra virgin olive oil, fruits, vegetables, nonrefined grains, and legumes; moderate to high consumption of fish; low to moderate intake of poultry and dairy products; low intake of red and processed meat; and avoidance of sugary drinks, fast food, and food rich in animal fat versus usual care. Participants received individualised dietary advice at 18, 20, and 28 weeks’ gestation. The primary endpoints were composite maternal (gestational diabetes or preeclampsia) and composite offspring (stillbirth, small for gestational age, or admission to neonatal care unit) outcomes prioritised by a Delphi survey. We used an intention-to-treat (ITT) analysis with multivariable models and identified the stratification variables and prognostic factors a priori. We screened 7,950 and randomised 1,252 women. Baseline data were available for 593 women in the intervention (93.3% follow-up, 553/593) and 612 in the control (95.6% follow-up, 585/612) groups. Over a quarter of randomised women were primigravida (330/1,205; 27%), 60% (729/1,205) were of Black or Asian ethnicity, and 69% (836/1,205) were obese. Women in the intervention arm consumed more nuts (70.1% versus 22.9%; adjusted odds ratio [aOR] 6.8, 95% confidence interval [CI] 4.3–10.6, p ≤ 0.001) and extra virgin olive oil (93.2% versus 49.0%; aOR 32.2, 95% CI 16.0–64.6, p ≤ 0.001) than controls; increased their intake of fish (p < 0.001), white meat (p < 0.001), and pulses (p = 0.05); and reduced their intake of red meat (p < 0.001), butter, margarine, and cream (p < 0.001). There was no significant reduction in the composite maternal (22.8% versus 28.6%; aOR 0.76, 95% CI 0.56–1.03, p = 0.08) or composite offspring (17.3% versus 20.9%; aOR 0.79, 95% CI 0.58–1.08, p = 0.14) outcomes. There was an apparent reduction in the odds of gestational diabetes by 35% (aOR 0.65, 95% CI 0.47–0.91, p = 0.01) but not in other individual components of the composite outcomes. Mothers gained less gestational weight (mean 6.8 versus 8.3 kg; adjusted difference −1.2 Kg, 95% CI −2.2 to −0.2, p = 0.03) with intervention versus control. There was no difference in any of the other maternal and offspring complications between both groups. When we pooled findings from the Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM) trial with similar trials using random effects meta-analysis, we observed a significant reduction in gestational diabetes (odds ratio [OR] 0.67, 95% CI 0.53–0.84, I2 = 0%), with no heterogeneity (2 trials, 2,397 women). The study’s limitations include the use of participant reported tools for adherence to the intervention instead of objective biomarkers. Conclusions A simple, individualised, Mediterranean-style diet in pregnancy did not reduce the overall risk of adverse maternal and offspring complications but has the potential to reduce gestational weight gain and the risk of gestational diabetes.
format info:eu-repo/semantics/article
id oai:dadun.unav.edu:10171-63702
institution Universidad de Navarra
language eng
publishDate 2022
publisher Public Library of Science (PLoS)
record_format dspace
spelling oai:dadun.unav.edu:10171-637022022-06-29T01:04:44Z Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial Al-Wattar, B.H. (Bassel H.) Dodds, J. (Julie) Placzek, A. (Anna) Beresford, L. (Lee) Spyreli, E. (Eleni) Moore, A. (Amanda) González-Carreras, F.J. (Francisco J.) Austin, F. (Frances) Murugesu, N. (Nilaani) Roseboom, T.J. (Tessa J.) Bes-Rastrollo, M. (Maira) Hitman, G. (Graham) Hooper, R. (Richard) Khan, K.S. (Khalid S.) Thangaratinam, S. (Shakila) Pregnant women Metabolic risk factors Mediterranean-style diet Pregnancy outcomes Background Pregnant women with metabolic risk factors are at high risk of complications. We aimed to assess whether a Mediterranean-style diet reduces adverse pregnancy outcomes in high-risk women. Methods and findings We conducted a multicentre randomised trial in 5 maternity units (4 in London and 1 in Birmingham) between 12 September 2014 and 29 February 2016. We randomised inner-city pregnant women with metabolic risk factors (obesity, chronic hypertension, or hypertriglyceridaemia) to a Mediterranean-style diet with high intake of nuts, extra virgin olive oil, fruits, vegetables, nonrefined grains, and legumes; moderate to high consumption of fish; low to moderate intake of poultry and dairy products; low intake of red and processed meat; and avoidance of sugary drinks, fast food, and food rich in animal fat versus usual care. Participants received individualised dietary advice at 18, 20, and 28 weeks’ gestation. The primary endpoints were composite maternal (gestational diabetes or preeclampsia) and composite offspring (stillbirth, small for gestational age, or admission to neonatal care unit) outcomes prioritised by a Delphi survey. We used an intention-to-treat (ITT) analysis with multivariable models and identified the stratification variables and prognostic factors a priori. We screened 7,950 and randomised 1,252 women. Baseline data were available for 593 women in the intervention (93.3% follow-up, 553/593) and 612 in the control (95.6% follow-up, 585/612) groups. Over a quarter of randomised women were primigravida (330/1,205; 27%), 60% (729/1,205) were of Black or Asian ethnicity, and 69% (836/1,205) were obese. Women in the intervention arm consumed more nuts (70.1% versus 22.9%; adjusted odds ratio [aOR] 6.8, 95% confidence interval [CI] 4.3–10.6, p ≤ 0.001) and extra virgin olive oil (93.2% versus 49.0%; aOR 32.2, 95% CI 16.0–64.6, p ≤ 0.001) than controls; increased their intake of fish (p < 0.001), white meat (p < 0.001), and pulses (p = 0.05); and reduced their intake of red meat (p < 0.001), butter, margarine, and cream (p < 0.001). There was no significant reduction in the composite maternal (22.8% versus 28.6%; aOR 0.76, 95% CI 0.56–1.03, p = 0.08) or composite offspring (17.3% versus 20.9%; aOR 0.79, 95% CI 0.58–1.08, p = 0.14) outcomes. There was an apparent reduction in the odds of gestational diabetes by 35% (aOR 0.65, 95% CI 0.47–0.91, p = 0.01) but not in other individual components of the composite outcomes. Mothers gained less gestational weight (mean 6.8 versus 8.3 kg; adjusted difference −1.2 Kg, 95% CI −2.2 to −0.2, p = 0.03) with intervention versus control. There was no difference in any of the other maternal and offspring complications between both groups. When we pooled findings from the Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM) trial with similar trials using random effects meta-analysis, we observed a significant reduction in gestational diabetes (odds ratio [OR] 0.67, 95% CI 0.53–0.84, I2 = 0%), with no heterogeneity (2 trials, 2,397 women). The study’s limitations include the use of participant reported tools for adherence to the intervention instead of objective biomarkers. Conclusions A simple, individualised, Mediterranean-style diet in pregnancy did not reduce the overall risk of adverse maternal and offspring complications but has the potential to reduce gestational weight gain and the risk of gestational diabetes. 2022-06-28T09:44:12Z 2022-06-28T09:44:12Z 2019 info:eu-repo/semantics/article https://hdl.handle.net/10171/63702 eng info:eu-repo/semantics/openAccess application/pdf Public Library of Science (PLoS)
spellingShingle Pregnant women
Metabolic risk factors
Mediterranean-style diet
Pregnancy outcomes
Al-Wattar, B.H. (Bassel H.)
Dodds, J. (Julie)
Placzek, A. (Anna)
Beresford, L. (Lee)
Spyreli, E. (Eleni)
Moore, A. (Amanda)
González-Carreras, F.J. (Francisco J.)
Austin, F. (Frances)
Murugesu, N. (Nilaani)
Roseboom, T.J. (Tessa J.)
Bes-Rastrollo, M. (Maira)
Hitman, G. (Graham)
Hooper, R. (Richard)
Khan, K.S. (Khalid S.)
Thangaratinam, S. (Shakila)
Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
title Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
title_full Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
title_fullStr Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
title_full_unstemmed Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
title_short Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
title_sort mediterranean-style diet in pregnant women with metabolic risk factors (esteem): a pragmatic multicentre randomised trial
topic Pregnant women
Metabolic risk factors
Mediterranean-style diet
Pregnancy outcomes
url https://hdl.handle.net/10171/63702
work_keys_str_mv AT alwattarbhbasselh mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT doddsjjulie mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT placzekaanna mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT beresfordllee mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT spyrelieeleni mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT mooreaamanda mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT gonzalezcarrerasfjfranciscoj mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT austinffrances mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT murugesunnilaani mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT roseboomtjtessaj mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT besrastrollommaira mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT hitmanggraham mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT hooperrrichard mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT khankskhalids mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial
AT thangaratinamsshakila mediterraneanstyledietinpregnantwomenwithmetabolicriskfactorsesteemapragmaticmulticentrerandomisedtrial