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

NCT07411001 | Active Not Recruiting DMC

• 1 other identifier: 101137440
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of the European Hypiend project, which aims to explore the effects of co-exposure to endocrine disruptor 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 consequences on the neuroendocrine system during the perinatal and prepubertal phases. The intervention at 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

Keywords

Prepubertal children; Intervention; Endocrine disruptors

Outcome Measures

Primary Outcomes (1)

• Change in urinary concentration of BPA

  Very few studies have looked at whether educational programs that teach people how to reduce their exposure to EDCs can actually lower the levels of these chemicals in urine, especially in children. In one study by Kim JH et al. (2021), 62 mothers with young children took part in an online program that encouraged healthier behaviors, and after one month, most of the chemical levels measured in their urine had changed significantly. Another study by Sessa et al. (2021) involved 130 primary-school children whose school canteen used a plastic-free service for six months; this led to a clear drop in the children's urinary Bisphenol A (BPA) levels. Given this background, our study selects urinary BPA concentration as the primary outcome.

  From enrollment to the end of the intervention at 26 months

Secondary Outcomes (3)

• Number of participants in precocious puberty, as assessed by the Tanner scale and the Prepubertal Development Scale (PDS)

  From enrollment to the end of the intervention at 26 months

• Change from baseline in BMI z-score

  From enrollment to the end of the intervention at 26 months

• Change from baseline in executive function T-scores as assessed by the Behavior Rating Inventory of Executive Function (BRIEF) parent-report questionnaire

  From enrollment to the end of the intervention at 26 months

Other Outcomes (1)

• Identifying predictors of high EDC exposure in children

  From enrollment to the end of the intervention at 26 months

Study Arms (2)

Multi-Component Behavioral intervention group

EXPERIMENTAL

The intervention is a 28-month MBI promoting an "EDC-free culture" in schools (called holistic schools) and families through shared values, knowledge and behaviours to reduce exposure to EDCs in daily life. Based on the HAPA and PBS, it is introduced at three levels: (1) School: implementation of plastic-free organic canteens, staff engagement, and explicit teaching of EDC-free behaviours with positive reinforcement; (2) Parents: workshops (on-site/online) and a mobile app offering personalised missions, practical guidance, and community support; (3) Children: educational activities to raise awareness and foster healthy habits.

Behavioral: Multi-Component Behavioral intervention

Information group

PLACEBO COMPARATOR

In this arm, the parents and the schools (called general schools) involved will receive a digital booklet about nature and risks of EDCs, general information on routes of exposures, and placebo workshops on the dangers of screens, the benefits of physical activity and the importance of good sleep habits. Neither the parents nor the schools in this group will be involved in any specific intervention aiming at reducing exposure to EDCs. At the end of the project, the parents of information group will have access to all the options proposed by digital tool and to the documents produced following the workshops or the questions and answers of the participants in the intervention group. The schools will receive the educational programme proposed to the intervention group.

Behavioral: Information

Interventions

Information BEHAVIORAL

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

Information group

Multi-Component Behavioral intervention BEHAVIORAL

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.

Multi-Component Behavioral intervention group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For children: aged between 6 and 8 from participating schools, and their parents/legal guardians.
• For parents/legal guardians:
• Understanding the local languages (either French in Belgium, or Spanish/Catalan in Spain) and being able to complete forms in that language;
• Be in possession of a smartphone. However, if participants do not have a smartphone and wish to do so, a smartphone will be made available to them for the duration of the study.

You may not qualify if:

• For schools :
• The number of participating children in the school is less than 5.
• Not being ready to devote time to the project.
• For children :
• If children do not agree to participate (ICF for children), the parents will be asked to discuss the matter with them before the child is excluded.
• If the parents or legal guardians do not sign the informed consent.
• For parents/legal guardians :
• If the parents refuse to participate.
• If the parents do not wish to use a mobile phone as part of the project, they will not be included in the sample.

Sponsors & Collaborators

• Sciensano: lead
• Fundació Institut Germans Trias i Pujol: collaborator
• University of Liege: collaborator
• European Union (Horizon Europe Programme): collaborator
• Fundació Eurecat: collaborator

Study Sites (1)

Sciensano

Brussels, 1050, Belgium

Location

Related Publications (2)

• Sessa F (2021) Effects of a Plastic-Free Lifestyle on Urinary Bisphenol A Levels in School-Aged Children of Southern Italy: A Pilot Study. Front. Public Health; 9-626090

  BACKGROUND

• Kim JH (2021). Web-based behavioral intervention to reduce exposure to phthalate metabolites, bisphenol A, triclosan, and parabens in mothers with young children: A randomized controlled trial. Int J Hyg Environ Health; 236:113798

  BACKGROUND

Related Links

• Description Official website of the interventional study

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ariane Baye, PhD

  ULiège

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Study of a MBI in primary schools aimed at reducing exposure to EDCs, based on changes in behavioral habits. The intervention includes school educational programs, workshops for parents, mobile application for parents, plastic-free canteens. This intervention will be compared with a group of control schools that will receive placebo workshops about others health preventions, in order to assess whether or not these changes produce a decrease in exposure to EDC in urine, changes in the age of onset of pubertal signs, cognitive function and anthropometric parameters, among other variables.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: February 13, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)