Improving Mothers for a Better PrenAtal Care Trial Barcelona

NCT03166332 | Completed DMC

• 1 other identifier: IMPACT BCN
• Study Type: interventional
• Target: 1,221
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Intrauterine Growth Restriction; Fetal Growth Retardation

Keywords

Mindfulness; Mediterranean diet; Neurodevelopment; Epigenetics; Fetal growth restriction

Outcome Measures

Primary Outcomes (1)

• Fetal Growth Restriction (FGR)

  Birth weight \<10th percentile

  Delivery

Secondary Outcomes (1)

• Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)

  Pregnancy

Other Outcomes (2)

• Fetal Programming

  Up to 24 months of age

• Epigenetics

  Delivery

Study Arms (3)

Mediterranean diet

ACTIVE COMPARATOR

Mediterranean diet supplemented with extra-virgin olive oil and mixed nuts.

Behavioral: Mediterranean diet

Mindfulness

ACTIVE COMPARATOR

Mindfulness-Based Stress Reduction program (MBSR)

Behavioral: Mindfulness

No intervention

NO INTERVENTION

No intervention strategy

Interventions

Mediterranean diet BEHAVIORAL

Mediterranean diet supplemented with extra-virgin olive oil and nuts

Mediterranean diet

Mindfulness BEHAVIORAL

Mindfulness-Based Stress Reduction program (MBSR)

Mindfulness

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Sant Joan de Deu

Barcelona, Spain

Location

Related Publications (6)

• 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.

  PMID: 40759394 DERIVED

• 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.

  PMID: 38830408 DERIVED

• 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.

  PMID: 37839546 DERIVED

• 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.

  PMID: 37606923 DERIVED

• 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.

  PMID: 34874420 DERIVED

• 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.

  PMID: 34030703 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Diet, Mediterranean; Mindfulness

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider will not know the arm of randomization
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ICGON and BCNatal

Model Details: Randomized controlled trial with 3 arms of intervention

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 25, 2017
• Study Start: February 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)