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Intrauterine Growth RestrictionIMPACTBCNNCT03166332

Improving Mothers for a Better PrenAtal Care Trial Barcelona

A study testing Mediterranean diet and Mindfulness in people with Intrauterine Growth Restriction and Fetal Growth Retardation, run by Hospital Clinic of Barcelona at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mediterranean diet and Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,221 participants
Where
2 sitesSpain
Study dates
1 Feb 2017to 31 Dec 2021
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Maternal age at recruitment ≥18 years
  • Speak Spanish fluently
  • Viable singleton non-malformed fetus
  • High-risk pregnancy to develop FGR.
  • 19-23 weeks of gestation

Who cannot join

  • Fetal anomalies including chromosomal abnormalities or structural malformations detected by ultrasound.
  • Mental retardation or other mental or psychiatric disorders that impose doubts regarding the true patient´s willingness to participate in the study.
  • No possibility to come to additional visits.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Sant Joan de Deu

    Barcelona

Other trials in Spain

About this study

High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.

Read the detailed description

Randomized controlled trial among women at higher risk to have a growth restricted fetus (30%) according to Royal College of Obstetrics and Gynecology (RCOG) Guidelines. These high-risk women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.

Main hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development.

Secondary hypothesis is that interventions to improve maternal lifestyle well being have a positive impact on offspring's outcome later in life, in terms of neurodevelopment and cardiovascular profile, mediated by epigenetic changes in offspring.

Being tested
Mediterranean diet, Mindfulness
Keywords
Mindfulness, Mediterranean diet, Neurodevelopment, Epigenetics, Fetal growth restriction
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean dietBehavioural

    Mediterranean diet supplemented with extra-virgin olive oil and nuts

  • MindfulnessBehavioural

    Mindfulness-Based Stress Reduction program (MBSR)

Study groups in NCT03166332
Study groupRoleWhat they receive
Mediterranean dietActive comparatorMediterranean diet supplemented with extra-virgin olive oil and mixed nuts.
Receives: Behavioral: Mediterranean diet
MindfulnessActive comparatorMindfulness-Based Stress Reduction program (MBSR)
Receives: Behavioral: Mindfulness
No interventionNo interventionNo intervention strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fetal Growth Restriction (FGR)

    Birth weight <10th percentile

    Measured: Delivery

Secondary outcomes (1)

  1. Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)

    Development of one of the following conditions: preeclampsia, preterm delivery, severe FGR (birth weight <3rd percentile), perinatal mortality, metabolic acidosis, mejor neonatal morbidity (presence of intraventricular hemorrhage grade III/IV, necrotizing enterocolitis, periventricular leucomalacia, sepsis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy)

    Measured: Pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2017
  2. Study start1 Feb 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2021

Resources

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
Model description
Randomized controlled trial with 3 arms of intervention
Masking
Single blind
Who is masked
Care provider
Enrolment
1,221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03166332
Sponsor's protocol ID
IMPACT BCN
Acronym
IMPACTBCN
Status last verified
Apr 2022
First submitted
19 Apr 2017
Last updated
19 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participants will be recruited in our unit and data will be available only for researchers involved in the study.

Publications

  • Trejo-Dominguez A, Benitez L, Crovetto F, Casas R, Youssef L, Larroya M, Ruiz-Leon AM, Nakaki A, Genero M, Casas I, Novoa RH, Encabo N, Rahman M, Wang X, O'Sullivan JF, Hegarty NR, Vieta E, Gratacos E, Estruch R, Crispi F, Castro-Barquero S. Ultraprocessed foods consumption and risk of preeclampsia: a secondary analysis of the improving mothers for a better prenatal care trial Barcelona (IMPACT BCN) randomized clinical trial. Am J Clin Nutr. 2026 May;123(5):101255. doi: 10.1016/j.ajcnut.2026.101255. Epub 2026 Mar 2.

    PubMed 41780730

  • Selma-Royo M, Crispi F, Castro-Barquero S, Casas I, Larroya M, Genero M, Paules C, Benitez L, Youssef L, Pascal R, Encabo N, Nakaki A, Martin-Asuero A, Oller-Guzman MT, Arranz A, Vieta E, Casas R, Estruch R, Gratacos E, Collado MC, Crovetto F. Effects of Mediterranean diet or Mindfulness-Based Stress Reduction during pregnancy on maternal gut and vaginal microbiota: a subanalysis of the Improving Mothers for a better PrenAtal Care Trial BarCeloNa (IMPACT BCN) trial. Am J Clin Nutr. 2025 Oct;122(4):1121-1133. doi: 10.1016/j.ajcnut.2025.07.030. Epub 2025 Aug 5.

    PubMed 40759394

  • Castro-Barquero S, Crovetto F, Estruch R, Ruiz-Leon AM, Larroya M, Sacanella E, Casanovas-Garriga F, Casas I, Nakaki A, Youssef L, Trejo-Dominguez A, Benitez L, Genero M, Vieta E, Gratacos E, Crispi F, Casas R. Validation of a pregnancy-adapted Mediterranean Diet Adherence Screener (preg-MEDAS): a validation study nested in the Improving Mothers for a better PrenAtal Care Trial BarCeloNa (IMPACT BCN) trial. Am J Clin Nutr. 2024 Aug;120(2):449-458. doi: 10.1016/j.ajcnut.2024.05.025. Epub 2024 Jun 1.

    PubMed 38830408

  • Nakaki A, Crovetto F, Urru A, Piella G, Borras R, Comte V, Vellve K, Paules C, Segales L, Dacal M, Gomez Y, Youssef L, Casas R, Castro-Barquero S, Martin-Asuero A, Oller Guzman T, Morilla I, Martinez-Aran A, Camacho A, Pascual Tutusaus M, Arranz A, Rebollo-Polo M, Gomez-Chiari M, Bargallo N, Pozo OJ, Gomez-Gomez A, Izquierdo Renau M, Eixarch E, Vieta E, Estruch R, Crispi F, Gonzalez-Ballester MA, Gratacos E. Effects of Mediterranean diet or mindfulness-based stress reduction on fetal and neonatal brain development: a secondary analysis of a randomized clinical trial. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101188. doi: 10.1016/j.ajogmf.2023.101188. Epub 2023 Oct 14.

    PubMed 37839546

  • Crovetto F, Nakaki A, Arranz A, Borras R, Vellve K, Paules C, Boutet ML, Castro-Barquero S, Freitas T, Casas R, Martin-Asuero A, Oller Guzman T, Morilla I, Martinez-Aran A, Camacho A, Pasqual M, Izquierdo Renau M, Pozo OJ, Gomez-Gomez A, Estruch R, Vieta E, Crispi F, Gratacos E. Effect of a Mediterranean Diet or Mindfulness-Based Stress Reduction During Pregnancy on Child Neurodevelopment: A Prespecified Analysis of the IMPACT BCN Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330255. doi: 10.1001/jamanetworkopen.2023.30255.

    PubMed 37606923

  • Crovetto F, Crispi F, Casas R, Martin-Asuero A, Borras R, Vieta E, Estruch R, Gratacos E; IMPACT BCN Trial Investigators. Effects of Mediterranean Diet or Mindfulness-Based Stress Reduction on Prevention of Small-for-Gestational Age Birth Weights in Newborns Born to At-Risk Pregnant Individuals: The IMPACT BCN Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2150-2160. doi: 10.1001/jama.2021.20178.

    PubMed 34874420

  • Crovetto F, Crispi F, Borras R, Paules C, Casas R, Martin-Asuero A, Arranz A, Vieta E, Estruch R, Gratacos E. Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial. Trials. 2021 May 24;22(1):362. doi: 10.1186/s13063-021-05309-2.

    PubMed 34030703

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean diet and Mindfulness in people with Intrauterine Growth Restriction and Fetal Growth Retardation, run by Hospital Clinic of Barcelona at 2 sites in Spain.

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 5 inclusion and 3 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Fetal Growth Restriction (FGR) (time frame: Delivery). 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 NCT03166332, which also lists 7 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 19 Apr 2022.

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