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

NCT06614413 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2024-09-26

No results posted yet for this study

Summary

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.

Conditions

  • Diet, Mediterranean
  • Pregnancy Related
  • Child Development
  • Infant Behaviour

Interventions

OTHER

Neurodevelopment and behaviour assesment 2 years old

Mothers: 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

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Miguel Saenz de Pipaon Marcos, Professor · HOspital La Paz Institute for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-12-31
Completion
2029-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614413 on ClinicalTrials.gov