ESTEEM 

 

Centres: Centre for Primary Care and Public Health.
Research Groups: Women's Health Research Unit, Pragmatic Clinical Trials Unit.
Full title: Effect of simple, targeted diet in pregnant women with metabolic risk factors on pregnancy outcomes: A randomised trial
Research Funder: Barts Charity 
Research status: Recruitment closed / in follow up

OVERVIEW

Pre-eclampsia, a condition in pregnancy with raised blood pressure and protein in the urine is a leading cause of deaths in the mother and baby. Pregnant women with obesity, raised lipids, diabetes and high blood pressure are at high risk of developing pre-eclampsia in pregnancy and heart diseases in the long run. Women in east London are at significant risk with high proportion with above risk factors.

The study is undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000 women/ year. The study is supported by the office of the Mayor of Tower Hamlets which will facilitate the involvement of grassroots workers to promote recruitment and uptake of the intervention.

 

 

STAFF

Investigators

Chief Investigator:

Professor Shakila Thangaratinam, Professor of Maternal and Perinatal Medicine, Women's Health Research Unit, Centre for Primary Care and Public Health, Blizard Institute Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Co-investigators:

Professor Khalid Khan, Professor of Women's Health and Clinical Epidemiology, Lead for Population Health Theme,  Centre for Primary Care and Public Health, Blizard Institute Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Prof Graham Hitman, Professor of Molecular Medicine and Diabetes. Centre Lead for Diabetes, Centre for Diabetes, Blizard Institute Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Dr Richard Hooper, Senior Lecturer in Medical Statistics, Centre for Primary Care and Public Health, Blizard Institute Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Prof Maira Bes-Rastrollo, Associate Professor, Dept.  Preventive Medicine and Public Health, University of Navarra, Spain Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Prof Tessa Jacoba Roseboom, Associate Professor of Early development and health, Obstetrics and Gynaecology & Clinical Epidemiology and Biostatistics, Academic Medical Centre at University of Amsterdam Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Dr Julie Dodds, Senior Clinical Trials Manager, Women's Health Research Unit, Centre for Primary Care and Public Health, Blizard Institute Email:This email address is being protected from spambots. You need JavaScript enabled to view it.

Research Team

Trial Coordinator
a.placzekThis email address is being protected from spambots. You need JavaScript enabled to view it. 
Tel: 020 7882 6049
 

Bassel Wattar
Researcher
This email address is being protected from spambots. You need JavaScript enabled to view it.

Eleni Spyreli
Dietician
eleni.spyreliThis email address is being protected from spambots. You need JavaScript enabled to view it.

OTHER INFORMATION

Obesity is a growing problem in east London and every other woman who enters pregnancy is obese or overweight. In addition to obesity, other metabolic risk factors such as raised lipids, high blood pressure and insulin resistance are increasingly prevalent. Dietary habits and underlying genetic predisposition are major contributors to this phenomenon. Obesity and raised serum lipids, especially triglycerides, increase the risk of complications such as pre-eclampsia in pregnancy and cardiovascular events such as myocardial infarction, stroke and death in the long term. 

Interventions that reduce cardiovascular events by modifying metabolic risk factors also have the potential to reduce the risk of pre-eclampsia. Our work funded by the NIHR in the UK showed that dietary interventions in obese pregnant women may reduce the risk of pre-eclampsia. We propose to show that pregnant women with metabolic risk factors derive the most benefit from a simple, targeted intervention based on Mediterranean dietary pattern to prevent maternal and fetal complications. 

Sample size: 4100 women

Aims and Objectives:

We aim to evaluate the effectiveness of simple, targeted dietary intervention in reducing the risk of maternal and fetal complications in pregnant women with metabolic risk factors such as obesity, raised lipids and high blood pressure. The specific objectives are as follows:

Primary objective:

To compare, in pregnant women with metabolic risk factors, the effect of simple, targeted diet (Mediterranean, including olive oil and nuts, composed within a culturally appropriate meal plan) vs. usual antenatal dietary advice in reducing the risk of 1. Composite maternal (pre-eclampsia or gestational diabetes) and 2. Composite fetal (stillbirth, small for gestational age or admission to neonatal intensive care unit) outcomes.

Secondary objectives:

To assess the effect of targeted dietary intervention vs. usual antenatal dietary advice on other maternal and fetal outcomes.

To study the change in lipid profile from early pregnancy to delivery in women a) with and without dietary interventions b) with and without pre-eclampsia on composite maternal and fetal outcomes.

To study the effect of the dietary intervention on composite maternal and fetal outcomes in the following subgroups of women: obese; raised triglycerides and with raised blood pressure.

To establish a cohort for medium and long term follow up of mothers and babies after birth through applications to other grant giving bodies.