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Randomized Controlled Trial
. 2023 Aug 1;6(8):e2330255.
doi: 10.1001/jamanetworkopen.2023.30255.

Effect of a Mediterranean Diet or Mindfulness-Based Stress Reduction During Pregnancy on Child Neurodevelopment: A Prespecified Analysis of the IMPACT BCN Randomized Clinical Trial

Francesca Crovetto  1   2 , Ayako Nakaki  1   3 , Angela Arranz  1 , Roger Borras  4   5 , Kilian Vellvé  1 , Cristina Paules  1 , Maria Laura Boutet  1 , Sara Castro-Barquero  1   6   7 , Tania Freitas  1   6   7 , Rosa Casas  6   7 , Andrés Martín-Asuero  8 , Teresa Oller Guzmán  8 , Ivette Morilla  9 , Anabel Martínez-Àran  9 , Alba Camacho  1 , Mireia Pasqual  1 , Montserrat Izquierdo Renau  2   10 , Óscar J Pozo  11 , Alex Gomez-Gomez  11 , Ramon Estruch  6   7 , Eduard Vieta  9 , Fàtima Crispi  1   3   12 , Eduard Gratacós  1   2   12
Affiliations
Randomized Controlled Trial

Effect of a Mediterranean Diet or Mindfulness-Based Stress Reduction During Pregnancy on Child Neurodevelopment: A Prespecified Analysis of the IMPACT BCN Randomized Clinical Trial

Francesca Crovetto et al. JAMA Netw Open. .

Abstract

Importance: Maternal suboptimal nutrition and high stress levels are associated with adverse fetal and childhood neurodevelopment.

Objective: To test the hypothesis that structured interventions based on a Mediterranean diet or mindfulness-based stress reduction (MBSR) during pregnancy improve child neurodevelopment at age 2 years.

Design, setting, and participants: This was a prespecified analysis of the parallel-group Improving Mothers for a Better Prenatal Care Trial Barcelona (IMPACT BCN) randomized clinical trial, which was conducted at a university hospital in Barcelona, Spain, from February 2017 to March 2020. A total of 1221 singleton pregnancies (19 to 23 weeks' gestation) with high risk of delivering newborns who were small for gestational age were randomly allocated into 3 groups: a Mediterranean diet intervention, an MBSR program, or usual care. A postnatal evaluation with the Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III), was performed. Data were analyzed from July to November 2022.

Interventions: Participants in the Mediterranean diet group received monthly individual and group educational sessions and free provision of extra virgin olive oil and walnuts. Those in the stress reduction group underwent an 8-week MBSR program adapted for pregnancy. Individuals in the usual care group received pregnancy care per institutional protocols.

Main outcomes and measures: Neurodevelopment in children was assessed by Bayley-III at 24 months of corrected postnatal age.

Results: A total of 626 children (293 [46.8%] female and 333 [53.2%] male) participated at a mean (SD) age of 24.8 (2.9) months. No differences were observed in the baseline characteristics between intervention groups. Compared with children from the usual care group, children in the Mediterranean diet group had higher scores in the cognitive domain (β, 5.02; 95% CI, 1.52-8.53; P = .005) and social-emotional domain (β, 5.15; 95% CI, 1.18-9.12; P = .01), whereas children from the stress reduction group had higher scores in the social-emotional domain (β, 4.75; 95% CI, 0.54-8.85; P = .02).

Conclusions and relevance: In this prespecified analysis of a randomized clinical trial, maternal structured lifestyle interventions during pregnancy based on a Mediterranean diet or MBSR significantly improved child neurodevelopmental outcomes at age 2 years.

Trial registration: ClinicalTrials.gov Identifier: NCT03166332.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Crovetto reported personal fees from Centro de Investigaciones Biomédicas en Red sobre Enfermedades Raras during the conduct of the study. Dr Nakaki reported personal fees from La Caixa Foundation (doctoral INPhINIT retaining) during the conduct of the study. Dr Castro-Barquero reported grants from University of Barcelona Margarita Salas (postdoctoral fellowship) during the conduct of the study. Dr Martín-Asuero reported grants from La Caixa foundation and personal fees from Editorial Planeta during the conduct of the study; personal fees from Editorial Plataforma and Societat Andorrana de Ciències, speaker’s fees from Eisai, and training fees from Chiesi Farma and Institut Guttmann outside the submitted work; and being founder and owner of Instituto esMindfulness. Dr Oller Guzmán reported personal fees from Instituto esMindfulness during the conduct of the study. Dr Martinez-Àran reported royalties from Cambridge University Press. Dr Estruch reported grants from Instituto de Salud Carlos III, European Commission, National Institute of Health, and Fivin; nonfinancial support from Fundación Bosch I Gimpera (research support), Patrimonio Comunal Olivarero (olive oil for trial), Fundacio Clinic (research support), California Walnut Commission (walnuts for trial), Brewers of Europe, Pernaud Richart, Mexico Wine and Culinary International Forum, Grand-Fountain Laboratories (organizing European conferences), Fundación Cerveza y Salud (educational conferences), Fundacion Dieta Mediterranea (educational conferences), Karolinska Institute, Menarini Laboratories, Sweden International Symposium on Cardiovascular Risk, the Pontifical Academy of Sciences, Wine and Culinary International Forum (educational conferences), Grand-Fountain Laboratories, and Dallant Laboratories (technical consultations) outside the submitted work. Dr Vieta reported personal fees from Abbott, Allergan, Angelini, Lundbeck, Sage, and Sanofi and grants from Dainippon Sumitomo, Ferrer, and Janssen outside the submitted work. Dr Gratacós reported grants from CaixaResearch, Cerebra Foundation for the Brain Injured Child, and Agency for Management of University and Research Grants during the conduct of the study as well as book royalties from Columna Edicions and Editorial Medica Panamericana and grants from Roche Diagnostics International (paid to institution) outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Eligibility, Randomization, and Follow-Up
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