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
| Autor: | Fatima Crispi, Roger Borràs, Francesca Crovetto, Rosa Casas, A. Arranz, Andrés Martín-Asuero, Eduard Vieta, Ramon Estruch, Eduard Gratacós, Cristina Paules |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pediatrics
Medicine (General) Mindfulness Mediterranean diet Teràpia cognitiva basada en l'atenció plena Embaràs Psychological intervention Medicine (miscellaneous) Diet Mediterranean law.invention Study Protocol 0302 clinical medicine Clinical trials Randomized controlled trial Retard del creixement intrauterí law Pregnancy Pharmacology (medical) 030212 general & internal medicine Child Randomized Controlled Trials as Topic education.field_of_study 030219 obstetrics & reproductive medicine Fetal Growth Retardation Fetal growth restriction Prenatal Care Complications of pregnancy Mindfulness-Based Stress Reduction Female medicine.medical_specialty Estils de vida Mindfulness-based cognitive therapy Population Lifestyles Mothers Prenatal care Mindfulness-based stress reduction Fetal growth retardation 03 medical and health sciences Mediterranean cooking R5-920 Cuina mediterrània medicine Humans education business.industry Perinatal outcome medicine.disease Complicacions en l'embaràs business Assaigs clínics |
| Zdroj: | Trials, Vol 22, Iss 1, Pp 1-14 (2021) Trials Dipòsit Digital de la UB Universidad de Barcelona |
| ISSN: | 1745-6215 |
| Popis: | 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.govNCT03166332. Registered on April 19, 2017 |
| Databáze: | OpenAIRE |
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