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Title: 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
Author: Crovetto, Francesca
Crispi Brillas, Fàtima
Borras, Roger
Paules, Cristina
Casas Rodríguez, Rosa M.
Martín Asuero, Andrés
Arranz Betegón, Ángela
Vieta i Pascual, Eduard, 1963-
Estruch Riba, Ramon
Gratacós Solsona, Eduard
Keywords: Embaràs
Assaigs clínics
Complicacions en l'embaràs
Cuina mediterrània
Teràpia cognitiva basada en l'atenció plena
Estils de vida
Retard del creixement intrauterí
Clinical trials
Complications of pregnancy
Mediterranean cooking
Mindfulness-based cognitive therapy
Fetal growth retardation
Issue Date: 24-May-2021
Publisher: BioMed Central
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.
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It is part of: Trials, 2021, vol. 22, p. 362-375
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ISSN: 1745-6215
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (BCNatal Fetal Medicine Research Center)

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