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

. 2021 May 24;22:362. doi: 10.1186/s13063-021-05309-2

Title {1}	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.
Trial registration {2a and 2b}.	ClinicalTrials.gov, NCT03166332. Registered 19 April 2017 - Prospectively registered before any outcome occurs. https://clinicaltrials.gov/ct2/results?cond=&term=NCT03166332&cntry=&state=&city=&dist=.
Protocol version {3}	Version 2, 23.10.2019
Funding {4}	The project is funded by: a grant from “La Caixa” Foundation (LCF/PR/GN18/10310003); Cerebra Foundation for the Brain Injured Child (Carmarthen, Wales, UK), and AGAUR under grant 2017 SGR n° 1531. Additionally, F. Crovetto has received funding from Centro de Investigaciones Biomédicas en Red sobre Enfermedades Raras (CIBERER).
Author details {5a}	Francesca Crovetto^1,2, MD, PhD; Fàtima Crispi^1,2, MD, PhD; Roger Borras^1,3, PhD; Cristina Paules¹, MD, PhD; Rosa Casas⁴, PhD; Andrés Martín⁵, PhD; Angela Arranz¹, PhD; Eduard Vieta⁶, MD, PhD; Ramon Estruch^4,7, MD, PhD; Eduard Gratacos^1,2, MD, PhD. ¹BCNatal \| Fetal Medicine Research Center (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain ²Centre for Biomedical Research on Rare Diseases (CIBER-ER), Madrid, Spain ³Cardiovascular Institute, Hospital Clínic, University of Barcelona, Barcelona, Spain; ⁴Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBERON), Instituto de Salud Carlos III, Madrid, Spain; ⁵Instituto esMindfulness, Barcelona, Spain; ⁶Department of Psychiatry and Psychology, Hospital Clinic, Neuroscience Institute, IDIBAPS, University of Barcelona, CIBERSAM, Barcelona, Spain; ⁷Department of Internal Medicine Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain.
Name and contact information for the trial sponsor {5b}	Several founders, the principal one is La Caixa Foundation. Contact: healthresearcher@fundaciolacaixa.org
Role of sponsor {5c}	The funders had no role in the study design; data collection, data analysis, data interpretation; or writing.