Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years for the Improvement of Neurological Development

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital Universitario La Paz

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

Qualifiers

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

Treatments tested in this trial

  • Neurodevelopment and behaviour assesment 2 years old

Treatment groups

534 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators