Mediterranean Diet
BehavioralMediterranean diet supplemented with extra-virgin olive oil and nuts
NCT Number: NCT03166332
High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.
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Female
Interventional
Not applicable
Hospital Clinic Barcelona, Barcelona, Spain
Randomized controlled trial among women at higher risk to have a growth restricted fetus (30%) according to Royal College of Obstetrics and Gynecology (RCOG) Guidelines. These high-risk women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.
Main hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development.
Secondary hypothesis is that interventions to improve maternal lifestyle well being have a positive impact on offspring's outcome later in life, in terms of neurodevelopment and cardiovascular profile, mediated by epigenetic changes in offspring.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mediterranean diet supplemented with extra-virgin olive oil and nuts
Mindfulness-Based Stress Reduction program (MBSR)
Time frame: Delivery
Birth weight <10th percentile
Time frame: Pregnancy
Development of one of the following conditions: preeclampsia, preterm delivery, severe FGR (birth weight <3rd percentile), perinatal mortality, metabolic acidosis, mejor neonatal morbidity (presence of intraventricular hemorrhage grade III/IV, necrotizing enterocolitis, periventricular leucomalacia, sepsis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy)
Time frame: Up to 24 months of age
Neurodevelopment assessment with Bayley III test
Time frame: Delivery
Different epigenetic changes in fetal cord blood in pregnancies affected by FGR who attend the interventional program as compared to pregnancies with no intervention
Hospital Clinic of Barcelona
Other
Acronym: IMPACTBCN
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