title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  NCT02218931; Pre-results.
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Bassel H
authors: BH
authors: Al Wattar
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Julie
authors: J
authors: Dodds
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Anna
authors: A
authors: Placzek
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Eleni
authors: E
authors: Spyreli
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Amanda
authors: A
authors: Moore
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Richard
authors: R
authors: Hooper
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Lee
authors: L
authors: Beresford
authors: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands.|Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands.
authors: Tessa J
authors: TJ
authors: Roseboom
authors: 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.
authors: Maira
authors: M
authors: Bes-Rastrollo
authors: Centre for Diabetes and Metabolic Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
authors: Graham
authors: G
authors: Hitman
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.|Multidisciplinary Evidence Synthesis Hub (mEsh), Barts and the London School of Medicine, Queen Mary University London, London, UK.
authors: Khalid S
authors: KS
authors: Khan
authors: Women's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.|Multidisciplinary Evidence Synthesis Hub (mEsh), Barts and the London School of Medicine, Queen Mary University London, London, UK.
authors: Shakila
authors: S
authors: Thangaratinam
mesh_terms: D000293:Adolescent; D000328:Adult; D016640:Diabetes, Gestational / Q000209:etiology / Q000517:prevention & control; D038441:Diet, Mediterranean; D005247:Feeding Behavior; D005260:Female; D005333:Fetus; D005865:Gestational Age; D006801:Humans; D007230:Infant, Low Birth Weight; D015931:Intensive Care, Neonatal; D011225:Pre-Eclampsia / Q000209:etiology / Q000517:prevention & control; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods*; D012307:Risk Factors; D013222:State Medicine; D050497:Stillbirth
keywords: Gestational diabetes; Mediterranean diet; Pre-eclampsia; Pregnancy; Randomised trial.; obesity