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  • Effect of simple, targeted diet in pregnant women with metabolic risk factors on maternal and fetal outcomes (ESTEEM): study protocol for a pragmatic multicentre randomised trial

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Obstetrics and gynaecology
Protocol
Effect of simple, targeted diet in pregnant women with metabolic risk factors on maternal and fetal outcomes (ESTEEM): study protocol for a pragmatic multicentre randomised trial
  1. Bassel H Al Wattar1,
  2. Julie Dodds1,
  3. Anna Placzek1,
  4. Eleni Spyreli1,
  5. Amanda Moore1,
  6. Richard Hooper1,
  7. Lee Beresford1,
  8. Tessa J Roseboom2,3,
  9. Maira Bes-Rastrollo4,5,6,
  10. Graham Hitman7,
  11. Khalid S Khan1,8,
  12. Shakila Thangaratinam1,8
  13. for the ESTEEM study group
  1. 1Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
  2. 2Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands
  3. 3Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands
  4. 4Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain
  5. 5CIBERobn, Instituto de Salud Carlos III, Madrid, Spain
  6. 6IDISNA, Navarra Institute for Health Research, Pamplona, Spain
  7. 7Centre for Diabetes and Metabolic Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
  8. 8Multidisciplinary Evidence Synthesis Hub (mEsh), Barts and the London School of Medicine, Queen Mary University London, London, UK
  1. Correspondence to Dr Bassel H Al Wattar; dr.basselwa{at}gmail.com

Abstract

Introduction Women with metabolic risk factors are at higher risk of adverse pregnancy outcomes. Mediterranean-based dietary interventions have the potential to minimise these risks. We aim to evaluate the effectiveness of a simple, targeted intervention modelled on Mediterranean diet in preventing maternal and fetal complications in pregnant women with metabolic risk factors.

Methods and analysis Pregnant women with a singleton pregnancy <18 weeks gestation, and without pre-existing diabetes, chronic renal disease and autoimmune diseases will be recruited. Women with metabolic risk factors will be randomised to receive a dietary intervention based on a Mediterranean pattern, supplemented with extra virgin olive oil and mixed nuts until delivery. The intervention will be delivered through a series of one to one and group sessions. The primary outcome is a composite maternal outcome of pre-eclampsia or gestational diabetes and a composite fetal outcome of stillbirth, small for gestational age fetus or admission to the neonatal intensive care unit. Secondary outcomes include maternal, fetal, dietary and laboratory outcomes. We aim to randomise 1230 eligible women with metabolic risk factors. We will also compare the outcomes in women with and without these risk factors. The sample size will provide us with 80% power at 5% significance, assuming a 20% loss to follow-up to detect a 30% reduction in maternal and fetal complications.

Ethics and dissemination The ESTEEM trial is designed to provide a definitive estimate of the effects of Mediterranean dietary pattern in pregnancy on maternal and fetal outcomes. The pragmatic nature of ESTEEM ensures the applicability of its findings into clinical practice. The findings of the study will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the NHS Research Ethics Committees (14/EE/1048).

Trial registration number NCT02218931; Pre-results.

  • Randomised trial.
  • Pregnancy
  • Gestational diabetes
  • Pre-eclampsia
  • Mediterranean diet
  • obesity

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-013495

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    Footnotes

    • Contributors BHA wrote the first manuscript draft and is helping with in the study conduct; JD and AP are co-ordinating the study conduct and drafted the protocol; EP is delivering the intervention; RH and LB designed the statistical analysis plan, TJR, MB-R, GH and KSK helped in developing the protocol and ST revised the manuscript and is supervising the overall study conduct. All authors provided critical input to the manuscript.

    • Funding This work was supported by Bart's Charity. The California Walnut Commission and Blue Diamond Growers donated with thanks the mixed nuts provided to the ESTEEM participants. The trial sponsor is Queen Mary University of London.

    • Competing interests None declared.

    • Ethics approval NHS Research Ethics Committees.

    • Provenance and peer review Not commissioned; externally peer reviewed.