Khan, K.S. (Khalid S.)

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    Mediterranean diet based intervention in pregnancy to improve maternal and fetal outcomes: Methodological challenges and lessons learned from the multicentre ESTEEM study
    (Elsevier, 2017) Thangaratinam, S. (Shakila); Hitman, G. (Graham); Spyreli, E. (Eleni); Bes-Rastrollo, M. (Maira); Higgins, S. (Sally); Hooper, R. (Richard); Roseboom, T.J. (Tessa J.); Moore, A. (Amanda); Al-Wattar, B.H. (Bassel H.); Beresford, L. (Lee); Placzek, A. (Anna); Dodds, J. (Julie); Khan, K.S. (Khalid S.)
    Introduction: Evaluating complex dietary interventions such as Mediterranean diet in pregnancy presents unique methodological challenges. We present the challenges and the lessons learned from a multicentre randomised trial (ESTEEM) on Mediterranean-based dietary intervention in pregnancy. Methods: We recruited pregnant women who met our predefined inclusion criteria and randomised those with metabolic risk factors to the Mediterranean-based dietary intervention or routine antenatal care. We evaluated the effect of the ESTEEM intervention on composite maternal and fetal outcomes. Challenges and solutions: The main challenges were encountered in recruiting to ESTEEM, delivering the intervention, engaging clinical staff, assessing adherence and choosing the outcome measures. The large sample size coupled with the slow recruitment rate forced us to extend the recruitment period by 4 months. The limitation in available resources was overcome by opening sites in a step-wise approach. Engaging healthcare providers was promoted by embedding the recruitment and the follow-up activities into current clinical practice, and promoting research skills training. We delivered the intervention early on in the pregnancy to promote the dietary effect on healthy placentation and reduce metabolic risk factors. Participants and their families were actively involved in the dietary intervention to improve adherence through a series of group teaching sessions. A user-friendly short dietary questionnaire was developed and validated to assess adherence to the intervention. The trial composite primary outcome was chosen in consensus based on input from a panel of experts. Conclusion: The ESTEEM experience offers an insight into future pragmatic nutritional studies in pregnancy.
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    Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial
    (Public Library of Science (PLoS), 2019) Thangaratinam, S. (Shakila); González-Carreras, F.J. (Francisco J.); Hitman, G. (Graham); Austin, F. (Frances); Spyreli, E. (Eleni); Murugesu, N. (Nilaani); Bes-Rastrollo, M. (Maira); Hooper, R. (Richard); Roseboom, T.J. (Tessa J.); Moore, A. (Amanda); Al-Wattar, B.H. (Bassel H.); Beresford, L. (Lee); Placzek, A. (Anna); Dodds, J. (Julie); Khan, K.S. (Khalid S.)
    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.