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

Autor: H Al Wattar B; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.; Warwick Medical School, University of Warwick, Coventry, United Kingdom., Dodds J; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Placzek A; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Beresford L; Pragmatic Clinical Trials Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Spyreli E; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Moore A; Diabetes & Nutritional Sciences Division, Faculty of Life Sciences & Medicine, King's College, London, United Kingdom., Gonzalez Carreras FJ; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Austin F; Maternity Dietetic Service, Women's and Children's Services, Barts NHS Trust, London, United Kingdom., Murugesu N; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Roseboom TJ; Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, the Netherlands.; Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands., Bes-Rastrollo M; Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.; CIBERobn, Instituto de Salud Carlos III, Madrid, Spain.; IDISNA, Navarra Institute for Health Research, Pamplona, Spain., Hitman GA; Barts Diabetes and Obesity Research Group, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Hooper R; Pragmatic Clinical Trials Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom., Khan KS; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.; Multidisciplinary Evidence Synthesis Hub (mEsh), Blizard Institute, Barts and the London School of Medicine, Queen Mary University London, London, United Kingdom., Thangaratinam S; BARC (Barts Research Centre for Women's Health), Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.; Multidisciplinary Evidence Synthesis Hub (mEsh), Blizard Institute, Barts and the London School of Medicine, Queen Mary University London, London, United Kingdom.
Jazyk: angličtina
Zdroj: PLoS medicine [PLoS Med] 2019 Jul 23; Vol. 16 (7), pp. e1002857. Date of Electronic Publication: 2019 Jul 23 (Print Publication: 2019).
DOI: 10.1371/journal.pmed.1002857
Abstrakt: 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.
Trial Registration: ClinicalTrials.gov NCT02218931.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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