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...

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2021 May 25

PMID 34030703

Citations 13

Authors

Francesca Crovetto

Fatima Crispi

Roger Borras

Cristina Paules

Rosa Casas

Andres Martin-Asuero

Angela Arranz

Eduard Vieta

Ramon Estruch

Eduard Gratacos

Affiliations

Soon will be listed here.

Abstract

Background: Fetal growth restriction (FGR) affects 7-10% of all pregnancies resulting in a higher risk of perinatal morbidity and mortality, long-term disabilities, and cognitive impairment. Due to its multifactorial etiology, changes in maternal lifestyle, including suboptimal maternal diet and stress, have increasingly been associated with its prevalence. We present a protocol for the Improving Mothers for a better PrenAtal Care Trial Barcelona (IMPACT BCN), which evaluates two different maternal lifestyle strategies (improved nutrition by promoting Mediterranean diet and stress reduction program based on mindfulness techniques) on perinatal outcomes. The primary objective is to reduce the prevalence of FGR. Secondary aims are to reduce adverse perinatal outcomes and to improve neurodevelopment and cardiovascular profile in children at 2 years of age.

Methods: A randomized parallel, open-blind, single-center trial following a 1:1:1 ratio will select and randomize high-risk singleton pregnancies for FGR (N=1218), according to the criteria of the Royal College of Obstetricians and Gynaecologists (19.0-23.6 weeks' gestation), into three arms: Mediterranean diet, mindfulness-based stress reduction program, and usual care without any intervention. Compliance to the interventions will be randomly tested in 30% of participants with specific biomarkers. Maternal socio-demographic, clinical data, biological samples, and lifestyle questionnaires will be collected at enrollment and at the end of the interventions (34.0-36.6 weeks' gestation), together with a fetoplacental ultrasound and magnetic resonance. Fetoplacental biological samples and perinatal outcomes will be recorded at delivery. Postnatal follow-up is planned up to 2 years of corrected age including neurodevelopmental tests and cardiovascular assessment. Intention-to-treat and population per-protocol analysis will be performed.

Discussion: This is the first randomized study evaluating the impact of maternal lifestyle interventions during pregnancy on perinatal outcomes. The maternal lifestyle interventions (Mediterranean diet and mindfulness-based stress reduction program) are supported by scientific evidence, and their compliance will be evaluated with several biomarkers.

Trial Registration: ClinicalTrials.gov NCT03166332 . Registered on April 19, 2017.

Citing Articles

Effect of Mediterranean diet or mindfulness-based stress reduction during pregnancy on placental volume and perfusion: A subanalysis of the IMPACT BCN randomized clinical trial.

Nakaki A, Denaro E, Crimella M, Castellani R, Vellve K, Izquierdo N Acta Obstet Gynecol Scand. 2024; 103(10):2042-2052.

PMID: 39037192 PMC: 11426209. DOI: 10.1111/aogs.14874.

The Mediterranean Diet in Pregnancy: Implications for Maternal Brain Morphometry in a Secondary Analysis of the IMPACT BCN Randomized Clinical Trial.

Nakaki A, Gomez Y, Castro-Barquero S, Conti A, Vellve K, Casas I Nutrients. 2024; 16(11).

PMID: 38892540 PMC: 11174669. DOI: 10.3390/nu16111604.

Gestational Weight Gain and Neonatal Biometry during the COVID-19 Pandemic: A Multicenter Observational Cohort.

Abdelwahab M, de Voest J, Metz T, Hughes B, Grobman W, Saade G Am J Perinatol. 2024; 42(2):189-195.

PMID: 38810962 PMC: 11666801. DOI: 10.1055/a-2335-2480.

Association between maternal mental health-related hospitalisation in the 5 years prior to or during pregnancy and adverse birth outcomes: a population-based retrospective cohort data linkage study in the Northern Territory of Australia.

Dadi A, He V, Brown K, Hazell-Raine K, Reilly N, Giallo R Lancet Reg Health West Pac. 2024; 46:101063.

PMID: 38659431 PMC: 11040136. DOI: 10.1016/j.lanwpc.2024.101063.

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.

Crovetto F, Nakaki A, Arranz A, Borras R, Vellve K, Paules C JAMA Netw Open. 2023; 6(8):e2330255.

PMID: 37606923 PMC: 10445211. DOI: 10.1001/jamanetworkopen.2023.30255.

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