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
Por:
Crovetto F, Crispi F, Borràs Amoraga Roger, Paules C, Casas R, Martín-Asuero A, Arranz A, Vieta E, Estruch R and Gratacós E
Publicada:
24 may 2021
Ahead of Print:
24 may 2021
Categoría:
Medicine (miscellaneous)
Resumen:
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.
Filiaciones:
Crovetto F:
BCNatal | Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
Centre for Biomedical Research on Rare Diseases (CIBER-ER), Madrid, Spain
Crispi F:
BCNatal | Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
Centre for Biomedical Research on Rare Diseases (CIBER-ER), Madrid, Spain.
Borràs Amoraga Roger:
BCNatal | Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
Cardiovascular Institute, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain
:
BCNatal | Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
Casas R:
Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBERON), Instituto de Salud Carlos III, Madrid, Spain
Martín-Asuero A:
Instituto esMindfulness, Barcelona, Spain
Arranz A:
BCNatal | Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
Vieta E:
Department of Psychiatry and Psychology, Hospital Clinic, Neuroscience Institute, IDIBAPS, CIBERSAM, University of Barcelona, Barcelona, Spain
Estruch R:
Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBERON), Instituto de Salud Carlos III, Madrid, Spain
Department of Internal Medicine Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain
Gratacós E:
BCNatal | Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
Centre for Biomedical Research on Rare Diseases (CIBER-ER), Madrid, Spain
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