Al Wattar, Bassel H., Dodds, Julie, Placzek, Anna, Beresford, Lee, Spyreli, Eleni, Moore, Amanda, Gonzalez-Carreras, Francisco J., Austin, Frances, Murugesu, Nilaani, Roseboom, Tessa J., Bes-Rastrollo, Maira, Hitman, Graham A., Hooper, Richard, Khan, Khalid S. and Thangaratinam, Shakila (2019) Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM) : a pragmatic multicentre randomised trial. PLoS Medicine, 16 (7). e1002857. doi:10.1371/journal.pmed.1002857

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Abstract

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.

Item Type:	Journal Article
Subjects:	R Medicine > RB Pathology R Medicine > RG Gynecology and obstetrics T Technology > TX Home economics
Divisions:	Faculty of Medicine > Warwick Medical School > Biomedical Sciences > Cell & Developmental Biology Faculty of Medicine > Warwick Medical School > Biomedical Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Diet -- Mediterranean Region, Cooking, Mediterranean -- Health aspects, Pregnancy -- Nutritional aspects, Metabolism -- Disorders
Journal or Publication Title:	PLoS Medicine
Publisher:	Public Library of Science
ISSN:	1549-1277
Official Date:	23 July 2019
Dates:	Date Event 23 July 2019 Available 19 June 2019 Accepted
Date of first compliant deposit:	20 June 2019
Volume:	16
Number:	7
Article Number:	e1002857
DOI:	10.1371/journal.pmed.1002857
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Contributors:	Contribution Name Contributor ID Research Group ESTEEM study group, UNSPECIFIED

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