Clinical Trial

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

Study acronym: Hypiend-PPC
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-08-04
Trial Details
NCT Number NCT07411001
Lead Sponsor Sciensano
Collaborators: Fundació Institut Germans Trias i Pujol, University of Liege, European Union, Fundació Eurecat
Conditions Precocious Puberty, Central, Executive Dysfunction
Enrollment 700 participants
Start Date 2025-09-15
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03