Status:
COMPLETED
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
Lead Sponsor:
Queen Mary University of London
Conditions:
Pre-eclampsia
Obesity
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief Summary
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 pr...
Detailed Description
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 insul...
Eligibility Criteria
Inclusion
- Pregnant women less than 18 weeks of gestation with at least one of the following:
- i. BMI ≥30 Kg/m2 ii. Raised serum triglycerides ≥1.7 mmol/l iii. Raised blood pressure of systole ≥140 mm Hg or diastole ≥90 mm Hg
Exclusion
- i. BMI \<18.5 Kg/m2or ≥40 Kg/m2 ii. Women on lipid altering drugs iii. History of diabetes iv. Chronic renal disease v. Auto immune disease vi. Multiple pregnancy vii. Poor understanding of written and spoken English viii. Not able to follow Mediterranean diet for religious or other reasons ix. \<16 years of age x. Not able to consume nuts or extra virgin olive oil
Key Trial Info
Start Date :
September 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
3442 Patients enrolled
Trial Details
Trial ID
NCT02218931
Start Date
September 12 2014
End Date
April 30 2017
Last Update
November 17 2017
Active Locations (1)
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1
Barts Health NHS Trust
London, United Kingdom, E1 1BB