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

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 str...

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Autores: Crovetto, Francesca, Crispi Brillas, Fàtima, Borràs, Roger, Paules, Cristina, Casas Rodríguez, Rosa M., Martín Asuero, Andrés, Arranz Betegón, Ángela, Vieta i Pascual, Eduard, 1963-, Estruch Riba, Ramon, Gratacós Solsona, Eduard
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/186045
Acesso em linha:https://hdl.handle.net/2445/186045
Access Level:acceso abierto
Palavra-chave:Embaràs
Assaigs clínics
Complicacions en l'embaràs
Cuina mediterrània
Teràpia cognitiva basada en l'atenció plena
Estils de vida
Retard del creixement intrauterí
Pregnancy
Clinical trials
Complications of pregnancy
Mediterranean cooking
Mindfulness-based cognitive therapy
Lifestyles
Fetal growth retardation
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oai_identifier_str oai:recercat.cat:2445/186045
network_acronym_str ES
network_name_str España
repository_id_str
spelling 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 trialCrovetto, FrancescaCrispi Brillas, FàtimaBorràs, RogerPaules, CristinaCasas Rodríguez, Rosa M.Martín Asuero, AndrésArranz Betegón, ÁngelaVieta i Pascual, Eduard, 1963-Estruch Riba, RamonGratacós Solsona, EduardEmbaràsAssaigs clínicsComplicacions en l'embaràsCuina mediterràniaTeràpia cognitiva basada en l'atenció plenaEstils de vidaRetard del creixement intrauteríPregnancyClinical trialsComplications of pregnancyMediterranean cookingMindfulness-based cognitive therapyLifestylesFetal growth retardationBackground: 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.BioMed Central2022202220212022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion14 p.application/pdfhttps://hdl.handle.net/2445/186045Articles publicats en revistes (Medicina)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1186/s13063-021-05309-2Trials, 2021, vol. 22, p. 362-375https://doi.org/10.1186/s13063-021-05309-2cc-by (c) Crovetto, Francesca et al., 2021https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1860452026-05-29T05:05:01Z
dc.title.none.fl_str_mv 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
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
spellingShingle 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
Crovetto, Francesca
Embaràs
Assaigs clínics
Complicacions en l'embaràs
Cuina mediterrània
Teràpia cognitiva basada en l'atenció plena
Estils de vida
Retard del creixement intrauterí
Pregnancy
Clinical trials
Complications of pregnancy
Mediterranean cooking
Mindfulness-based cognitive therapy
Lifestyles
Fetal growth retardation
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Crovetto, Francesca
Crispi Brillas, Fàtima
Borràs, Roger
Paules, Cristina
Casas Rodríguez, Rosa M.
Martín Asuero, Andrés
Arranz Betegón, Ángela
Vieta i Pascual, Eduard, 1963-
Estruch Riba, Ramon
Gratacós Solsona, Eduard
author Crovetto, Francesca
author_facet Crovetto, Francesca
Crispi Brillas, Fàtima
Borràs, Roger
Paules, Cristina
Casas Rodríguez, Rosa M.
Martín Asuero, Andrés
Arranz Betegón, Ángela
Vieta i Pascual, Eduard, 1963-
Estruch Riba, Ramon
Gratacós Solsona, Eduard
author_role author
author2 Crispi Brillas, Fàtima
Borràs, Roger
Paules, Cristina
Casas Rodríguez, Rosa M.
Martín Asuero, Andrés
Arranz Betegón, Ángela
Vieta i Pascual, Eduard, 1963-
Estruch Riba, Ramon
Gratacós Solsona, Eduard
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Embaràs
Assaigs clínics
Complicacions en l'embaràs
Cuina mediterrània
Teràpia cognitiva basada en l'atenció plena
Estils de vida
Retard del creixement intrauterí
Pregnancy
Clinical trials
Complications of pregnancy
Mediterranean cooking
Mindfulness-based cognitive therapy
Lifestyles
Fetal growth retardation
topic Embaràs
Assaigs clínics
Complicacions en l'embaràs
Cuina mediterrània
Teràpia cognitiva basada en l'atenció plena
Estils de vida
Retard del creixement intrauterí
Pregnancy
Clinical trials
Complications of pregnancy
Mediterranean cooking
Mindfulness-based cognitive therapy
Lifestyles
Fetal growth retardation
description 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.
publishDate 2021
dc.date.none.fl_str_mv 2021
2022
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/186045
url https://hdl.handle.net/2445/186045
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1186/s13063-021-05309-2
Trials, 2021, vol. 22, p. 362-375
https://doi.org/10.1186/s13063-021-05309-2
dc.rights.none.fl_str_mv cc-by (c) Crovetto, Francesca et al., 2021
https://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Crovetto, Francesca et al., 2021
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 14 p.
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.811543

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