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Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)

NCT07142447 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2025-08-26

No results posted yet for this study

Summary

The general objective of HYPIEND is to understand the effects of chemical substances called "endocrine disruptors" (EDCs) during the perinatal and pre-pubertal stages. EDCs co-exposure may affect the function of hormones and determine endocrine consequences in vulnerable populations.

The primary objective of this clinical study is to demonstrate that a multicomponent intervention implemented in health care centres from three European countries is effective in reducing the levels of EDCs in different body fluids of pregnant women, breastfeeding and formula feeding women as well as in their infants up to 18 months of age, improving at the same time the level of HAPA constructs (psychological determinants of behaviour) and the knowledge about these chemicals at family level.

Conditions

  • Pregnancy
  • Children

Interventions

BEHAVIORAL

Multi-Component Behavioral intervention

A multicomponent behavioral intervention during pregnancy and up to the first 18 months after delivery, composed by: 1. Digital tool called "App Hypiend Digital Tool" aimed at promoting lifestyle habits to reduce EDC exposure by providing personalized recommendations 2. Telephone monitoring 3. Workshop about environmental health education

BEHAVIORAL

Control group

Minimal behavioral intervention. Usual care

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universidad de Granada

    collaborator OTHER

  • Fundació Eurecat

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Inés Velasco, MD, PhD · Foundation Institute of Research in Health Sciences Germans Trias i Pujol

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-01-31
Completion
2027-07-31

Countries

  • Spain

Study Locations

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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 NCT07142447 on ClinicalTrials.gov