Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)

NCT07411001 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-08-03

No results posted yet for this study

Summary

This study is part of the European Hypiend project, which aims to explore the effects of co-exposure to endocrine-disrupting chemicals (EDCs) on the function and epigenetic programming of the hypothalamic-pituitary-adrenal (HPA) axis in order to define intervention strategies to minimize exposure and its consequences on the neuroendocrine system during the perinatal and prepubertal phases. The intervention during the perinatal phase is registered under the Unique Protocol ID: 101137440 - Hypiend - Clinical study to evaluate the effectiveness of a multicomponent behavioural intervention to reduce EDC exposure during the perinatal period in women and their offspring.

The intervention presented here concerns the prepubertal phase.

The primary objective is to demonstrate that a multi-component behavioral intervention (MBI) implemented in primary schools in two different European countries over two and a half school years is effective in reducing the presence of EDCs in the urine of prepubertal children, using the Health Action Process Approach (HAPA) and the Positive Behaviour Support (PBS) models to improve the intervention and parents' knowledge of these contaminants, as well as to advance scientific knowledge.

Conditions

  • Precocious Puberty, Central
  • Executive Dysfunction

Interventions

BEHAVIORAL

Information

In this intervention, participants will receive general information on EDCs and placebo workshops

BEHAVIORAL

Multi-Component Behavioral intervention

In this intervention, participants will have access to a mobile app that will provide information on EDCs and recommendations and missions to reduce exposure to EDCs. They will also be invited to attend workshops aiming to help them adopting behaviours to reduce exposure to EDCs in their daily life. Intervention will also be applied at the level of the schools.

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    collaborator OTHER
  • University of Liege

    collaborator OTHER
  • European Union

    collaborator OTHER
  • Fundació Eurecat

    collaborator OTHER
  • Sciensano

    lead OTHER_GOV

Principal Investigators

  • Ariane Baye, PhD · ULiège

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

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 NCT07411001 on ClinicalTrials.gov