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Among pregnant individuals at high risk for small-for-gestational age (SGA) newborns, is a Mediterranean diet or mindfulness-based stress reduction effective in preventing SGA at delivery?
In this randomized clinical trial that included 1184 individuals with singleton pregnancies, the percentage of newborns with birth weight below the 10th percentile was 14% in the Mediterranean diet group and 15.6% in the mindfulness-based stress reduction group, compared with 21.9% in the usual care group; both interventions resulted in a significantly lower percentage of SGA newborns compared with usual care.
Structured interventions based on a Mediterranean diet or mindfulness-based stress reduction significantly reduced the risk of SGA newborns in individuals at high risk for this condition; however, the findings require replication, as well as assessment in additional patient populations, before concluding that these treatments should be recommended to patients.
Being born small for gestational age (SGA) is a leading cause of perinatal morbidity and mortality with no effective prevention or therapy. Maternal suboptimal nutrition and high stress levels have been associated with poor fetal growth and adverse pregnancy outcomes.
To investigate whether structured interventions based on a Mediterranean diet or mindfulness-based stress reduction (stress reduction) in high-risk pregnancies can reduce the percentage of newborns who were born SGA and other adverse pregnancy outcomes.
Design, Setting, and Participants
Parallel-group randomized clinical trial conducted at a university hospital in Barcelona, Spain, including 1221 individuals with singleton pregnancies (19-23 weeks’ gestation) at high risk for SGA. Enrollment took place from February 1, 2017, to October 10, 2019, with follow-up until delivery (final follow-up on March 1, 2020).
Participants in the Mediterranean diet group (n = 407) received 2 hours monthly of individual and group educational sessions and free provision of extra-virgin olive oil and walnuts. Individuals in the stress reduction group (n = 407) underwent an 8-week stress reduction program adapted for pregnancy, consisting of weekly 2.5-hour sessions and 1 full-day session. Individuals in the usual care group (n = 407) received pregnancy care per institutional protocols.
Main Outcomes and Measures
The primary end point was the percentage of newborns who were SGA at delivery, defined as birth weight below the 10th percentile. The secondary end point was a composite adverse perinatal outcome (at least 1 of the following: preterm birth, preeclampsia, perinatal mortality, severe SGA, neonatal acidosis, low Apgar score, or presence of any major neonatal morbidity).
Among the 1221 randomized individuals (median [IQR] age, 37 [34-40] years), 1184 (97%) completed the trial (392 individuals assigned to the Mediterranean diet group, 391 to the stress reduction group, and 401 to the usual care group). SGA occurred in 88 newborns (21.9%) in the control group, 55 (14.0%) in the Mediterranean diet group (odds ratio [OR], 0.58 [95% CI, 0.40-0.84]; risk difference [RD], −7.9 [95% CI, −13.6 to −2.6]; P = .004), and 61 (15.6%) in the stress reduction group (OR, 0.66 [95% CI, 0.46-0.94]; RD, −6.3 [95% CI, −11.8 to −0.9]; P = .02). The composite adverse perinatal outcome occurred in 105 newborns (26.2%) in the control group, 73 (18.6%) in the Mediterranean diet group (OR, 0.64 [95% CI, 0.46-0.90]; RD, −7.6 [95% CI, −13.4 to −1.8]; P = .01), and 76 (19.5%) in the stress reduction group (OR, 0.68 [95% CI, 0.49-0.95]; RD, −6.8 [95% CI, −12.6 to −0.3]; P = .02).
Conclusions and Relevance
In this randomized trial conducted at a single institution in Spain, treating pregnant individuals at high risk for SGA with a structured Mediterranean diet or with mindfulness-based stress reduction, compared with usual care, significantly reduced the percentage of newborns with birth weight below the 10th percentile. Due to important study limitations, these findings should be considered preliminary and require replication, as well as assessment in additional patient populations, before concluding that these treatments should be recommended to patients.
ClinicalTrials.gov Identifier: NCT03166332
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Eduard Gratacós, MD, PhD, BCNatal (Hospital Sant Joan de Déu and Hospital Clínic), Universitat de Barcelona, Sabino de Arana 1, 08036 Barcelona, Spain (email@example.com).
Accepted for Publication: October 22, 2021.
Author Contributions: Drs Crovetto and Gratacós had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Crovetto and Crispi contributed equally.
Concept and design: Crovetto, Crispi, Martín-Asuero, Vieta, Estruch, Gratacós.
Acquisition, analysis, or interpretation of data: Crovetto, Crispi, Casas, Martín-Asuero, Borràs, Estruch, Gratacós.
Drafting of the manuscript: Crovetto, Crispi, Vieta, Gratacós.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Crovetto, Borràs, Estruch.
Obtained funding: Gratacós.
Administrative, technical, or material support: Crovetto, Martín-Asuero, Estruch.
Supervision: Crovetto, Crispi, Borràs, Vieta, Estruch, Gratacós.
Other - responsible for the Mediterranean diet program: Casas.
Other - responsible for the mindfulness-based stress reduction program: Martín-Asuero.
Conflict of Interest Disclosures: Dr Crovetto reported receiving personal fees from Centro de Investigaciones Biomédicas en Red sobre Enfermedades Raras for support for investigation (until July 2019) during the conduct of the study. Dr Crispi reported receiving grants from Hospital Clinic/Institut d'Investigacions Biomèdiques August Pi i Sunyer La Caixa foundation, Cerebra foundation, and Agència de Gestió d'Ajudes Universitaries i de Investigació (AGAUR) during the conduct of the study. Dr Martín-Asuero reported receiving grants from La Caixa during the conduct of the study and book royalties from Editorial Planeta and Méderic Ediciones, nonfinancial support from Soc Andorrana Ciencias, and personal fees from Instituto Guttmann and Technology Centre of Catalonia outside the submitted work and being the founder and owner of Instituto esMindfulness SL. Dr Borràs reported receiving personal fees from Fundació Privada per a la Recerca i la Docència Sant Joan de Déu during the conduct of the study. Dr Vieta reported receiving personal fees from Abbott, Allergan, Angelini, Sage, and Sanofi; and grants from Dainippon Sumitomo, Ferrer (money paid to his institution but no payment made as yet), and Janssen (money paid to his institution for trials on esketamine, JNJ-42165279, and MIJ821); and serving on advisory boards for and receiving personal fees from Lundbeck outside the submitted work. Dr Estruch reported receiving personal fees from Cerveza y salud, Fundación Dieta Mediterranea, Pernaud-Ricard, Instituto Cervantes, and nonfinancial support from Fundación de Investigación Sobre el Vino y Nutrición and Brewers of Europe; and grants from Grand Fountain Laboratories, Uriach Laboratories, Instituto de Salud Carlos III, EIT Digital, and JPI outside the submitted work. Dr Gratacós reported receiving grants from CaixaResearch (LCF/PR/GN18/10310003), Cerebra Foundation for the Brain Injured Child, and AGAUR Catalonia government (2017 SGR No. 1531) during the conduct of the study and book royalties from Columna Edicions and Editorial Medica Panamericana and grants from Roche Diagnostics International (paid to his institution) outside the submitted work. No other disclosures were reported.
Funding/Support: The project was partially funded by a grant from “La Caixa” Foundation (LCF/PR/GN18/10310003); Cerebra Foundation for the Brain Injured Child (Carmarthen, Wales, UK); AGAUR under grant 2017 SGR No. 1531. Dr Crovetto has received support from Centro de Investigaciones Biomédicas en Red sobre Enfermedades Raras (CIBERER). Dr Nakaki has received support from a fellowship from “La Caixa” Foundation, Doctoral INPhINIT Retaining fellowship (LCF/BQ/DR19/11740018).
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The IMPACT BCN Trial Investigators appear in Supplement 4.
Data Sharing Statement: See Supplement 5.
Additional Contributions: We thank the study participants for their personal time and commitment to this trial. We also thank all the medical staff, residents, midwives, and nurses of BCNatal, especially Laura Segales, BsC; Marta Dacal, MsC; Maria Laura Boutet, MD; Annachiara Basso, MD; Marta Larroya, MD; Marta Camacho, MD; Marta Garcia, MsC; Mireia Pascual, APRN; and Alba Camacho, APRN (BCNatal Fetal Medicine Research Center, Barcelona, Spain), for their support in the recruitment, interventions, and data collection of the trial; Carlos Galante, MsC (Department of Internal Medicine, Hospital Clinic, Barcelona, Spain, Barcelona, Spain), for his support in the Mediterranean diet intervention; Georgina Badosa, MsC; Amaia Helguera, BsC; and Sylvia Comas, MsC (Instituto esMindfulness, Barcelona, Spain), for their support in the stress reduction intervention; and Julian Lozano-Castellón, MsC; Anallely López-Yerena, MsC; Inés Domínguez-López, BsC; and Maria Marhuenda-Muñoz, MsC (School of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain), for their support in the biomarkers analysis of Mediterranean diet compliance. We thank the Clinic-IDIBAPS Biobank for valuable management of samples. Laura Segales, Marta Dacal, Marta Garcia, Mireia Pascual, Alba Camacho, Carlos Galante, Georgina Badosa, Amaia Helguera, Sylvia Comas, Julian Lozano-Castellón, Anallely López-Yerena, Inés Domínguez-López, and Maria Marhuenda-Muñoz received economic compensation for their role in the study. Additionally, the members of the IMPACT BCN Trial Investigators group made the following contributions: C. Paules, A. Nakaki, K. Vellvé, and G. Casu were directly involved in participant recruitment and data collection; S. Castro-Barquero and T. Freita were dietitians involved in the Mediterranean diet program; A. M. Ruiz-León and R. M. Lamuela-Raventós were responsible for the analysis of fatty acids and hydroxytyrosol metabolites; M. T. Oller-Guzmán was a mindfulness-based stress reduction instructor who led several groups; A. Martínez-Aràn and I. Morilla were psychologists involved in the stress reduction program; A. Gomez-Gomez and O. J. Pozo were responsible for the analysis of the 24-hour urinary cortisone/cortisol ratio; M. C. Collado and M. Selma-Royo contributed to the analysis and interpretation of the biological effects of the interventions; M. Domenech helped to implement the Mediterranean diet program; A. Arranz was responsible for the postnatal follow-up; F. Figueras contributed to the study design and manuscript writing, and supervised the statistical analysis.
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