Effects of Mediterranean diet or mindfulness-based stress reduction on fetal and neonatal brain development: a secondary analysis of a randomized clinical trial.

BACKGROUND: Maternal suboptimal nutrition and high stress levels are associated with adverse fetal and infant neurodevelopment. OBJECTIVE: This study aimed to investigate if structured lifestyle interventions involving a Mediterranean diet or mindfulness-based stress reduction during pregnancy are associated with differences in fetal and neonatal brain development. STUDY DESIGN: This was a secondary analysis of the randomized clinical trial Improving Mothers for a Better Prenatal Care Trial Barcelona that was conducted in Barcelona, Spain, from 2017 to 2020. Participants with singleton pregnancies were randomly allocated into 3 groups, namely Mediterranean diet intervention, stress reduction program, or usual care. Participants in the Mediterranean diet group received monthly individual sessions and free provision of extra-virgin olive oil and walnuts. Pregnant women in the stress reduction group underwent an 8-week mindfulness-based stress reduction program adapted for pregnancy. Magnetic resonance imaging of 90 fetal brains was performed at 36 to 39 weeks of gestation and the Neonatal Neurobehavioral Assessment Scale was completed for 692 newborns at 1 to 3 months. Fetal outcomes were the total brain volume and lobular or regional volumes obtained from a 3-dimensional reconstruction and semiautomatic segmentation of magnetic resonance images. Neonatal outcomes were the 6 clusters scores of the Neonatal Neurobehavioral Assessment Scale. Multiple regression analyses were conducted to assess the association between the interventions and the fetal and neonatal outcomes. RESULTS: When compared with the usual care group, the offspring exposed to a maternal Mediterranean diet had a larger total fetal brain volume (mean, 284.11 cm3; standard deviation, 23.92 cm3 vs 294.01 cm3; standard deviation, 26.29 cm3; P=.04), corpus callosum (mean, 1.16 cm3; standard deviation, 0.19 cm3 vs 1.26 cm3; standard deviation, 0.22 cm3; P=.03), and right frontal lobe (44.20; standard deviation, 4.09 cm3 vs 46.60; standard deviation, 4.69 cm3; P=.02) volumes based on magnetic resonance imaging measures and higher scores in the Neonatal Neurobehavioral Assessment Scale clusters of autonomic stability (mean, 7.4; standard deviation, 0.9 vs 7.6; standard deviation, 0.7; P=.04), social interaction (mean, 7.5; standard deviation, 1.5 vs 7.8; standard deviation, 1.3; P=.03), and range of state (mean, 4.3; standard deviation, 1.3 vs 4.5; standard deviation, 1.0; P=.04). When compared with the usual care group, offspring from the stress reduction group had larger fetal left anterior cingulate gyri volume (1.63; standard deviation, 0.32 m3 vs 1.79; standard deviation, 0.30 cm3; P=.03) based on magnetic resonance imaging and higher scores in the Neonatal Neurobehavioral Assessment Scale for regulation of state (mean, 6.0; standard deviation, 1.8 vs 6.5; standard deviation, 1.5; P<.01). CONCLUSION: Maternal structured lifestyle interventions involving the promotion of a Mediterranean diet or stress reduction during pregnancy were associated with changes in fetal and neonatal brain development.

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.

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 (ß, 5.02; 95% CI, 1.52-8.53; P = .005) and social-emotional domain (ß, 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 (ß, 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.

Effects of Mediterranean Diet or Mindfulness-Based Stress Reduction on Prevention of Small-for-Gestational Age Birth Weights in Newborns Born to At-Risk Pregnant Individuals: The IMPACT BCN Randomized Clinical Trial.

Importance: 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. Objective: 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). Interventions: 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). Results: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03166332.

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.

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.gov NCT03166332 . Registered on April 19, 2017.

Evaluación de la efectividad de un programa de mindfulness en profesionales de atención primaria / Effectiveness of a mindfulness program in primary care professionals

Objetivos: Evaluar la efectividad a largo plazo de un programa de entrenamiento en mindfulness dirigido a profesionales de atención primaria en el burnout, el estado emocional, la empatía y la conciencia plena. Métodos: Estudio de medidas repetidas antes-después. Participaron 87 profesionales de atención primaria. Se midieron el burnout (Inventario de Maslach), la alteración emocional (POMS), la empatía (Jefferson) y el mindfulness (FFMQ), la adherencia a la intervención y los cambios de actitudes. Las mediciones se realizaron al inicio, a las 8 semanas y a los 6 y 12 meses. La intervención duró 1 año, con dos fases: una intensiva de 28 horas, repartidas durante 8 semanas, y otra de mantenimiento de 2,5 horas mensuales en 10 meses. El efecto del programa se evaluó mediante diferencia de medias, respuesta media estandarizada (RME) y modelos mixtos de medidas repetidas. Resultados: La puntuación de todas las escalas mejoró significativamente durante todo el seguimiento respecto a los valores basales. Las mayores diferencias se obtuvieron a los 12 meses, destacando el FFMQ (RME: 1,4) seguido del POMS (RME: 0,8). La fase postintensiva presentó la mejora más acusada en la diferencia entre puntuaciones consecutivas. El FFMQ presentó grandes cambios en todas las fases. Al final de la intervención, el 89% de los participantes practicaba por su cuenta los ejercicios y el 94% indicó mejoras en autocuidado y profesionalismo. Conclusiones: Un programa psicoeducativo basado en mindfulness muestra en una disminución del burnout y de la alteración emocional, con una mejora en la empatía y en la conciencia plena, fomentando actitudes hacia el autocuidado (AU)

Objectives: To determine the long-term effects of a mindfulness program on burnout, mood states, empathy, and mindfulness in primary care professionals. Methods: A repeated measures before-after study was performed in 87 participants working in primary care. The variables evaluated were scores of the Burnout Inventory (Maslach), mood states (Profile of Mood States [POMS]), empathy (Jefferson Scale of Physician Empathy [JSPE]) and mindfulness (Five Facet Mindfulness Questionnaire [FFMQ]), adherence to the intervention, and changes in attitudes. Evaluations were performed at baseline, at 8 weeks, and at 6 and 12 months. The intervention lasted for 1 year and consisted of two training phases, an intensive first phase lasting 28 hours, spread over 8 weeks, and a second, maintenance phase of 25 hours spread over 10 months. The effect of the intervention was assessed through observed change, standardized response mean (SRM), and linear mixed-effects models on repeated measures. Results: The scores of all the scales improved significantly during the follow-up compared with baseline scores. The greatest differences were obtained at 12 months, especially in the the FFMQ (SRM: 1.4), followed by the POMS (SRM: 0,8). The greatest improvement in the maintenance phase was found in the difference between consecutive scores. The only scale that showed major changes in all phases was the FFMQ scale. At the end of the intervention, 89% of participants practiced the exercises of the program on their own and 94% reported improvements in self-care and greater professionalism. Conclusions: A psychoeducational program based on mindfulness reduces burnout and improves mood states, empathy, and mindfulness, while encouraging better self-care (AU)

[Effectiveness of a mindfulness program in primary care professionals]. / Evaluación de la efectividad de un programa de mindfulness en profesionales de atención primaria.

OBJECTIVES: To determine the long-term effects of a mindfulness program on burnout, mood states, empathy, and mindfulness in primary care professionals. METHODS: A repeated measures before-after study was performed in 87 participants working in primary care. The variables evaluated were scores of the Burnout Inventory (Maslach), mood states (Profile of Mood States [POMS]), empathy (Jefferson Scale of Physician Empathy [JSPE]) and mindfulness (Five Facet Mindfulness Questionnaire [FFMQ]), adherence to the intervention, and changes in attitudes. Evaluations were performed at baseline, at 8 weeks, and at 6 and 12 months. The intervention lasted for 1 year and consisted of two training phases, an intensive first phase lasting 28 hours, spread over 8 weeks, and a second, maintenance phase of 25 hours spread over 10 months. The effect of the intervention was assessed through observed change, standardized response mean (SRM), and linear mixed-effects models on repeated measures. RESULTS: The scores of all the scales improved significantly during the follow-up compared with baseline scores. The greatest differences were obtained at 12 months, especially in the the FFMQ (SRM: 1.4), followed by the POMS (SRM: 0,8). The greatest improvement in the maintenance phase was found in the difference between consecutive scores. The only scale that showed major changes in all phases was the FFMQ scale. At the end of the intervention, 89% of participants practiced the exercises of the program on their own and 94% reported improvements in self-care and greater professionalism. CONCLUSIONS: A psychoeducational program based on mindfulness reduces burnout and improves mood states, empathy, and mindfulness, while encouraging better self-care.

The mindfulness-based stress reduction program (MBSR) reduces stress-related psychological distress in healthcare professionals

This semi-experimental study examines how Mindfulness facilitates a distress reduction in a group of health professionals. The sample comprises 29 professionals seeking stress reduction who undertook an 8 weeks psico-educative intervention, involving 28 hours of class, based on a program called Mindfulness-based Stress Reduction or MBSR. Results show a 35% reduction of distress, from percentile 75 to 45, combined with a 30% reduction in rumination and a 20% decrease in negative affect. These benefits lasted during the 3 months of the follow up period. The correlation analysis indicates that the decrease in distress is significantly related to the other two variables. These results confirm the effectiveness of MBSR to decrease distress and its applicability in training programs for health professionals (AU)

Este estudio cuasi-experimental examina si el Mindfulness o conciencia plena reduce el malestar psicológico asociado al estrés en profesionales de la salud. La muestra estaba compuesta por 29 profesionales interesados en reducir el estrés, que siguieron una intervención psicoeducativa de 8 semanas, empleando un total de 28 horas lectivas y denominada Reducción de estrés basada en Mindfulness (Mindfulness-based Stress Reduction o MBSR). Los resultados muestran una disminución del malestar del 35%, descendiendo del percentil 75 al 45, así como reducciones del 30% en rumiación y del 20% en afectividad negativa. Estas mejoras se mantienen durante el periodo de seguimiento de 3 meses posteriores a la intervención. Las correlaciones encontradas indican que la reducción en malestar psicológico conlleva una disminución de la rumiación y de la afectividad negativa. Estos resultados confirman la utilidad de la técnica MBSR para reducir el malestar psicológico en programas de formación para profesionales de la salud (AU)

The Mindfulness-based Stress Reduction program (MBSR) reduces stress-related psychological distress in healthcare professionals.

This semi-experimental study examines how Mindfulness facilitates a distress reduction in a group of health professionals. The sample comprises 29 professionals seeking stress reduction who undertook an 8 weeks psico-educative intervention, involving 28 hours of class, based on a program called Mindfulness-based Stress Reduction or MBSR. Results show a 35% reduction of distress, from percentile 75 to 45, combined with a 30% reduction in rumination and a 20% decrease in negative affect. These benefits lasted during the 3 months of the follow up period. The correlation analysis indicates that the decrease in distress is significantly related to the other two variables. These results confirm the effectiveness of MBSR to decrease distress and its applicability in training programs for health professionals.