Obesity Clinical Trial
Official title:
Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM): A Randomised Trial
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 diabetes increase pregnancy related complications such as preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia, presenting as hypertension and proteinuria is a leading cause of maternal and fetal mortality and morbidity. Interventions that reduce cardiovascular events by modifying risk factors also have the potential to reduce the risk of preeclampsia. The investigators work funded by the National Institute of Health Research (NIHR) in the UK showed that dietary interventions in obese pregnant women may reduce the risk of preeclampsia. The investigators 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 reduce the risk of maternal and fetal complications . Women with the risk factors (1230 women) will be randomly allocated to dietary intervention or usual antenatal dietary advice and the risk of maternal and fetal complications will be evaluated. The remaining eligible women who are consented for lipid tests, but do not have metabolic risk factors, will be followed up for outcome data only. Diet based interventions, especially those based on a Mediterranean dietary pattern has a potential to reduce the risk of preeclampsia. In the investigators study, pregnant mothers with risk factors will be randomly allocated to either a dietary invention or usual antenatal care and they will assess their composite maternal (pre-eclampsia or gestational diabetes) and fetal (stillbirth, small for gestational age or admission to neonatal intensive care unit) outcomes. The investigators will tailor the intervention to suit the individual needs of the mother and provide nuts and olive oil to improve compliance. The study will be undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000 women/year and two other maternity units in England. 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.
Obesity is a growing problem in east London with a fifth of women entering pregnancy as
obese. In addition to obesity, other metabolic risk factors such as raised lipids, high blood
pressure and insulin resistance are increasingly prevalent. With a large proportion of ethnic
minority mothers in east London, 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 preeclampsia in pregnancy and
cardiovascular events such as myocardial infarction, stroke and death in the long term.
Preeclampsia, a condition in pregnancy, with raised blood pressure and increased protein in
the urine is a leading cause of maternal and fetal deaths. Its treatment gives rise to large
health care costs. Preeclampsia contributes to preterm birth, one of the leading causes of
perinatal deaths in east London. It accounts for 65% of neonatal deaths and 50% of
neurological disability in childhood. Around £900 million in extra costs for care of preterm
babies per year in the NHS are linked to neonatal care. Preeclampsia, characterised by
insulin resistance, widespread endothelial damage and dysfunction, coagulation defects and
increased systemic inflammatory response, shares metabolic risk factors with cardiovascular
disease. Obesity, dyslipidaemia and hypertension are independent risk factors for
pre-eclampsia. Interventions that reduce cardiovascular events by modifying metabolic risk
factors also have the potential to reduce the risk of pre-eclampsia.
Early identification of mothers at risk of preeclampsia will allow clinicians to deliver
these targeted interventions in pregnancy, with the potential to prevent preeclampsia and
modify cardiovascular risk in the long-term. Currently, low dose aspirin, recommended as a
prophylactic measure reduces preeclampsia risk by only 10%. Simple, low-cost and effective
acceptable interventions are required to reduce this risk further. Dietary interventions in
pregnant women with metabolic risk factors such as obesity and insulin resistance are shown
to reduce the risk of preeclampsia. But the existing studies are of poor quality and do not
evaluate preeclampsia as the primary outcome. Furthermore, they focus on specific components
of the diet, rather than modifying the overall dietary pattern. Mediterranean diet with high
consumption of vegetables and fruits, olive oil and nuts and low consumption of red meat and
processed food significantly reduces lipid levels and cardiovascular adverse events in
non-pregnant high risk population. In pregnancy, the beneficial effect of the Mediterranean
dietary pattern was observed in a large prospective study of nulliparous pregnant women with
a 28% reduction in the risk of preeclampsia (RR 0.72Íž 95% CI 0.62, 0.85). These results need
confirmation in a sound experimental study.
There is a need for an adequately powered randomised trial to evaluate the beneficial effect
of lipid modifying diet in pregnancy that is simple, accessible and acceptable. The
investigators hypothesis is that pregnant women with metabolic risk factors will derive
benefit from dietary intervention in preventing maternal and fetal complications.
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