Pre-eclampsiaESTEEMNCT02218931
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
A study testing Targeted ESTEEM diet and Non-randomised cohort in people with Pre-eclampsia and Obesity, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pre-eclampsia, Obesity, Raised Lipids
- What is being tested?
- Targeted ESTEEM diet and Non-randomised cohort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,442 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2014to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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 0.72; 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.
- Conditions
- Pre-eclampsia, Obesity, Raised Lipids, High Blood Pressure, Insulin Resistance, Gestational Diabetes
- Being tested
- Targeted ESTEEM diet, Non-randomised cohort
- 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
- Medical subject headings
- Pre-Eclampsia, Obesity, Hypertension, Insulin Resistance, Diabetes, Gestational, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted ESTEEM dietBehavioural
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
Non-randomised cohortOther
Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Non-randomised cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At delivery
Composite fetal outcomes: stillbirth, small for gestational age or admission to neonatal intensive care unit
Measured: At delivery
Secondary outcomes (4)
To assess the effect of targeted dietary intervention vs. usual antenatal dietary advice on other maternal and fetal outcomes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of follow up, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study start12 Sep 2014
- Primary completionNov 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shakila Thangaratinam, Principal investigator, Queen Mary University of LondonRehan Khan, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218931
- Sponsor's protocol ID
- 009337QM
- Other IDs
- 732/2029
- Acronym
- ESTEEM
- Status last verified
- Jan 2017
- First submitted
- 11 Jul 2014
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31335871Al 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.
PubMed 29740638Al 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.
PubMed 27798035
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM): A Randomised Trial
- ClinicalTrials.gov ID
- NCT02218931
- Acronym / sponsor ID
- ESTEEM / 009337QM
- Conditions
- Pre-eclampsia, Obesity, Raised Lipids, High Blood Pressure, Insulin Resistance, Gestational Diabetes
- Keywords
- Pre-eclampsia, Gestational diabetes, Stillbirth, Small for gestational age, Admission to neonatal intensive care unit, Obesity, Raised Lipids, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,442 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 0.72; 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Targeted ESTEEM diet | Experimental | Behavioral: Targeted ESTEEM dietThe 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 |
| 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 | Other: Non-randomised cohortNon-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted ESTEEM dietThe 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 | Behavioural | Targeted ESTEEM diet |
| Non-randomised cohortNon-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data | Other | Non-randomised cohort |
Primary outcome
Composite maternal outcomes: pre-eclampsia or gestational diabetes
Time frame: At delivery
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
Composite fetal outcomes: stillbirth, small for gestational age or admission to neonatal intensive care unit
Time frame: At delivery
4 secondary outcomes
To assess the effect of targeted dietary intervention vs. usual antenatal dietary advice on other maternal and fetal outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of follow up, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 31335871H 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.
- Derived from this study: PubMed 29740638Al 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.
- Derived from this study: PubMed 27798035Al 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shakila Thangaratinam principal investigator
Queen Mary University of London
Rehan Khan principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted ESTEEM diet and Non-randomised cohort in people with Pre-eclampsia and Obesity, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite maternal outcomes: pre-eclampsia or gestational diabetes (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218931, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.