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

NCT06614413 | Not Yet Recruiting DMC

• 2 other identifiers: HULP/6812PI24/0035
• Study Type: interventional
• Target: 534
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental assessment an behavior at 2 years old

  Neurodevelopmental assessment using the Bayleys scale version III

  Assessment at 2 years of age

Study Arms (2)

Mother-child binomial with nutritional intervention

ACTIVE COMPARATOR

Interventions will be based on dietary-nutritional advice, derived from scientific evidence: nutrition based on the Mediterranean diet (MD) and usual treatment

Other: Neurodevelopment and behaviour assesment 2 years old

Mother-child binomial as a control group (with follow-up without intervention).

PLACEBO COMPARATOR

Mother-child binomial as a control group, with follow-up without intervention.

Other: Neurodevelopment and behaviour assesment 2 years old

Interventions

Neurodevelopment and behaviour assesment 2 years old OTHER

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

Mother-child binomial as a control group (with follow-up without intervention).; Mother-child binomial with nutritional intervention

Eligibility Criteria

• Gender Eligibility Details: Pregnants
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Fluency in the Spanish language, singleton pregnancy

You may not qualify if:

• 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
• Participation in another controlled trial
• Vegetarian diet

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Officials

• Miguel Saenz de Pipaon Marcos, Professor

  HOspital La Paz Institute for Health Research

  STUDY DIRECTOR

Central Study Contacts

Escribano Palomino

CONTACT

34653178413; esperanza.escribano@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician; Neonatologist

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share