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
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 - 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
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