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.

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.

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

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(Abstracted from JAMA 2021;326:2150–2160)Babies with birth weights below the 10th percentile, or small for gestational age infants (SGA), are at risk of poor neurodevelopment or perinatal mortality. Although there is currently no effective prevention therapy for SGA, this study aimed to evaluate the value of structured lifestyle interventions such as a Mediterranean diet or stress reduction therapy in terms of reducing incidence of birth weight <10th percentile and adverse pregnancy outcomes.