About this trial
The main objective is to evaluate the effect of the Mediterranean diet during pregnancy and the first two years of the child\'s life on the child\'s neurodevelopment and behavior (externalizing and internalizing disorders) measured at one and a half and two years. Secondary objectives are to evaluate the effect of the Mediterranean diet on: body composition at two years of age in infants (densitometry) and of the mother at 3 months postpartum, the incidence of allergic disease in infants, the fetal and infant ́s growth and metabolic risk in the mother during pregnancy and in the boy/girl at two years (fasting glucose: insulin, HOMA), LDL and HDL cholesterol, and micronutrient status (iron, calcium, phosphorus, magnesium, sodium, potassium, chloride, selenium, zinc and LCPUFAs).
Randomized controlled clinical trial with a 1:1 ratio, parallel and open label. Group 1: Mother-child binomial with nutritional intervention; Group 2: Mother-child binomial as a control group (with follow-up without intervention).
Assuming a loss of 25% (10% at follow-up, 15% failure of nutritional intervention) we would need a sample size of 267 patients per group. 1. Evaluation of neurodevelopment using the Bayleys scale version -III, at 2 years of age. 2.
Behavioral assessment CBCL at 1.5 and two years and BRIEF-P at two years.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Children conceived with assisted reproduction techniques
Fetal anomalies and congenital infections
Neonatal anomalies diagnosed after birth
Intellectual development disorder, due to clinical judgment, inability to attend visits
Trial design
Parallel
Treatments tested in this trial
Neurodevelopment and behaviour assesment 2 years old
Other interventionMothers: Monthly visits guided or not by nutritionist (intervention vs control group) will consist in food questionnaires and 3-day food diary collection during pregnancy. Every three months during lactation. Children: From one year of age onwards, the KIDMED questionnaire will be administered quarterly Neurodevelopment and behavior assessment 18-24 months of age
Treatment groups
Trial outcomes
Primary outcomes
Neurodevelopmental assessment an behavior at 2 years old
Neurodevelopmental assessment using the Bayleys scale version III
Locations
Sponsors and contacts
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