ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes

NCT02218931 | Completed DMC

• 2 other identifiers: 009337QM732/2029
• Study Type: interventional
• Target: 3,442
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pre-eclampsia; Obesity; Raised Lipids; High Blood Pressure; Insulin Resistance; Gestational Diabetes; Small for Gestational Age; Stillbirth

Keywords

Pre-eclampsia; Gestational diabetes; Stillbirth; Small for gestational age; Admission to neonatal intensive care unit; Obesity; Raised Lipids; High Blood Pressure; Cardiovascular risk; Insulin resistance; Mediterranean dietary pattern; Dietary interventions

Outcome Measures

Primary Outcomes (2)

• Composite maternal outcomes: pre-eclampsia or gestational diabetes

  Diagnosis of pre-eclampsia defined as: * new onset hypertension after 20 weeks gestation defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mmHg, in at least two readings AND New onset proteinuria defined as spot urine Protein/creatinine ratio (PCR) test greater than 30mg/mmol or \>24 hour urine 300mg/24 hours or 2+ or more on standard urinary dipstick tests after 20 weeks gestation * superimposed pre-eclampsia in women with chronic hypertension or chronic proteinuria * women with eclamptic seizures with no hypertension or proteinuria Diagnosis of gestational diabetes defined as: * fasting venous glucose of 5·1 mmol/L or higher or * 2 h venous glucose of 8·5 mmol/L or higher or * combination of these

  At delivery

• Composite fetal outcomes: stillbirth, small for gestational age or admission to neonatal intensive care unit

  At delivery

Secondary Outcomes (4)

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

  At delivery

• The number of participants with a change in lipid profiles from early pregnancy to delivery in women a) with and without dietary interventions b) with and without pre-eclampsia on the composite maternal and fetal outcomes.

  At delivery

• The rates of composite maternal and fetal outcomes in the following subgroups of women in the intervention and control group: obese; raised triglycerides and with raised blood pressure.

  Baseline and 36 weeks or delivery depending on which is sooner

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

  End of follow up, an average of 5 months

Study Arms (3)

Targeted ESTEEM diet

EXPERIMENTAL

The ESTEEM dietary pattern is similar to that in a Mediterranean diet associated with reduced risk of pre-eclampsia. The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants

Behavioral: Targeted ESTEEM diet

Current clinical practice

NO INTERVENTION

The control group will be provided the usual antenatal dietary advice. This includes advice on healthy and physical activity in women with normal weight and obesity and overweight. Folic acid and vit D supplementation are provided as per national recommendations. Participants will provide outcome data at point of delivery and food frequency questionnaire at baseline and 36 weeks or delivery depending on which is sooner.

Non-randomised cohort

OTHER

Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data

Other: Non-randomised cohort

Interventions

Targeted ESTEEM diet BEHAVIORAL

The key components of the diet are: High intake of vegetables, nuts, non-refined grains, legumes and fruits;Moderate to high consumption of fish;Small to moderate intake of poultry and dairy products such as yoghurt and cheese;Low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and high fat food;High fibre;Intake of nuts including walnuts and almonds that are rich sources of monounsaturated and polyunsaturated fatty acids (30 g/day);Olive oil to cook and dress salads as the main source of fat (0.5 l/week) The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants

Targeted ESTEEM diet

Non-randomised cohort OTHER

Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data

Non-randomised cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (3)

• H Al Wattar B, Dodds J, Placzek A, Beresford L, Spyreli E, Moore A, Gonzalez Carreras FJ, Austin F, Murugesu N, Roseboom TJ, Bes-Rastrollo M, Hitman GA, Hooper R, Khan KS, Thangaratinam S; ESTEEM study group. Mediterranean-style diet in pregnant women with metabolic risk factors (ESTEEM): A pragmatic multicentre randomised trial. PLoS Med. 2019 Jul 23;16(7):e1002857. doi: 10.1371/journal.pmed.1002857. eCollection 2019 Jul.

  PMID: 31335871 DERIVED

• Al Wattar BH, Dodds J, Placzek A, Spyreli E, Higgins S, Moore A, Hooper R, Beresford L, Roseboom TJ, Bes-Rastrollo M, Hitman G, Khan KS, Thangaratinam S; ESTEEM study group. Mediterranean diet based intervention in pregnancy to improve maternal and fetal outcomes: Methodological challenges and lessons learned from the multicentre ESTEEM study. Contemp Clin Trials Commun. 2017 Mar 29;6:72-77. doi: 10.1016/j.conctc.2017.02.012. eCollection 2017 Jun.

  PMID: 29740638 DERIVED

• Al Wattar BH, Dodds J, Placzek A, Spyreli E, Moore A, Hooper R, Beresford L, Roseboom TJ, Bes-Rastrollo M, Hitman G, Khan KS, Thangaratinam S; ESTEEM study group. 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. BMJ Open. 2016 Oct 21;6(10):e013495. doi: 10.1136/bmjopen-2016-013495.

  PMID: 27798035 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Obesity; Hypertension; Insulin Resistance; Diabetes, Gestational; Stillbirth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Fetal Death; Death; Pathologic Processes

Study Officials

• Shakila Thangaratinam

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• Rehan Khan

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: August 18, 2014
• Study Start: September 12, 2014
• Primary Completion: November 1, 2016
• Study Completion: April 30, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-01

Locations

GB (1)