Evidence map›Paper›PMID 29740638›Full record

ArticleContemporary clinical trials communications2017

Mediterranean diet based intervention in pregnancy to improve maternal and fetal outcomes: Methodological challenges and lessons learned from the multicentre ESTEEM study.

Bassel H Al Wattar, Julie Dodds, Anna Placzek, Eleni Spyreli, Sally Higgins, Amanda Moore, Richard Hooper, Lee Beresford, Tessa J Roseboom, Maira Bes-Rastrollo and 4 more

Registry-linked trialAbstract read
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In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02218931 (Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02218931 nacompletednot on this map

Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM): A Randomised Trial

TypeinterventionalSponsorQueen Mary University of LondonRan2014 to 2017Enrolled3,442ConditionsPre-eclampsia, Obesity, Raised Lipids, High Blood PressureArmsTargeted ESTEEM diet, Non-randomised cohort
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Bassel H Al WattarWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Julie DoddsWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Anna PlaczekWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Eleni SpyreliWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Sally HigginsWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Amanda MooreDiabetes & Nutritional Sciences Division, Faculty of Life Sciences & Medicine, King's College, London, UK.
Richard HooperWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Lee BeresfordWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Tessa J RoseboomDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands.
Maira Bes-RastrolloDepartment of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.
Graham HitmanCentre for Diabetes and Metabolic Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Khalid S KhanWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Shakila ThangaratinamWomen's Health Research Unit, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
ESTEEM study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEvaluating complex dietary interventions such as Mediterranean diet in pregnancy presents unique methodological challenges. We present the challenges and the lessons learned from a multicentre randomised trial (ESTEEM) on Mediterranean-based dietary intervention in pregnancy.

methodsWe recruited pregnant women who met our predefined inclusion criteria and randomised those with metabolic risk factors to the Mediterranean-based dietary intervention or routine antenatal care. We evaluated the effect of the ESTEEM intervention on composite maternal and fetal outcomes. CHALLENGES AND SOLUTIONS: The main challenges were encountered in recruiting to ESTEEM, delivering the intervention, engaging clinical staff, assessing adherence and choosing the outcome measures. The large sample size coupled with the slow recruitment rate forced us to extend the recruitment period by 4 months. The limitation in available resources was overcome by opening sites in a step-wise approach. Engaging healthcare providers was promoted by embedding the recruitment and the follow-up activities into current clinical practice, and promoting research skills training. We delivered the intervention early on in the pregnancy to promote the dietary effect on healthy placentation and reduce metabolic risk factors. Participants and their families were actively involved in the dietary intervention to improve adherence through a series of group teaching sessions. A user-friendly short dietary questionnaire was developed and validated to assess adherence to the intervention. The trial composite primary outcome was chosen in consensus based on input from a panel of experts.

conclusionThe ESTEEM experience offers an insight into future pragmatic nutritional studies in pregnancy. TRIAL REGISTRATION NUMBER: NCT02218931.

Indexed as

Mediterranean dietObesityPregnancyRandomised trial

Identifiers

PMID29740638
PMCPMC5936842

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.