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-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

Keywords

Prepubertal children; Intervention; Endocrine disruptors

Outcome Measures

Primary Outcomes (1)

• Change in urinary concentration of bisphenol A (BPA)

  Very few studies have examined whether educational programs teaching individuals how to reduce their exposure to endocrine-disrupting chemicals can effectively lower urinary levels of these substances, particularly in children. In one study by Kim et al. (2021), sixty-two mothers with young children participated in an online program promoting healthier behaviors; after one month, most measured urinary chemical levels showed significant changes . Another study by Sessa et al. (2021) involved 130 primary-school children whose school canteen adopted plastic-free service for six months, resulting in a clear reduction in the children's urinary bisphenol A levels . Given this context, our study selects urinary bisphenol A concentration as the primary outcome. Analyses will be conducted on night-time and morning urine samples collected at four time points: at enrollment (Visit 1), after 8 months (Visit 2), after 20 months (Visit 3), and after 26 months (Visit 4).

  From enrollment to the end of the intervention at 26 months

Secondary Outcomes (3)

• Number of participants classified as at risk of precocious puberty

  From enrollment to the end of the intervention at 26 months

• Change from baseline in Body Mass Index 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 parent-report questionnaire

  From enrollment to the end of the intervention at 26 months

Other Outcomes (1)

• Proportion of children with elevated urinary endocrine-disrupting chemical concentrations

  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 multi-component behavioral intervention (MBI) promoting an "EDC-free culture" in schools (termed holistic schools) and families through shared values, knowledge, and behaviors to reduce exposure to endocrine-disrupting chemicals (EDCs) in daily life. Based on the Health Action Process Approach (HAPA) and Positive Behaviour Support (PBS) models, it is introduced at three levels: (1) School: implementation of plastic-free organic canteens, staff engagement, and explicit teaching of EDC-free behaviors with positive reinforcement; (2) Parents: workshops (on-site/online) and a mobile app offering personalized 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 schools (termed general schools) involved will receive a digital booklet about the nature and risks of endocrine-disrupting chemicals (EDCs), general information on exposure routes, 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 aimed at reducing exposure to EDCs. At the end of the project, the parents in the information group will have access to all options provided by the digital tool and to the documents produced following the workshops or the questions and answers from participants in the intervention group. The schools will receive the educational program 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.
• For schools:
• Fewer than 5 participating children enrolled in the school.
• Unwillingness or inability to devote sufficient time to the project.
• For children:
• Parents or legal guardians do not sign the informed consent form.
• For parents/legal guardians:
• Refusal to participate.

Sponsors & Collaborators

• Sciensano: lead
• Fundació Institut Germans Trias i Pujol: collaborator
• University of Liege: collaborator
• Fundació Eurecat: collaborator
• European Union: collaborator

Study Sites (1)

Sciensano

Brussels, 1050, Belgium

Location

Related Publications (3)

• Kim JH, Kwak JM, Kang H. 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. 2021 Jul;236:113798. doi: 10.1016/j.ijheh.2021.113798. Epub 2021 Jun 23.

  PMID: 34186503 BACKGROUND

• Sessa F, Polito R, Monda V, Scarinci A, Salerno M, Carotenuto M, Cibelli G, Valenzano A, Campanozzi A, Mollica MP, Monda M, Messina G. Effects of a Plastic-Free Lifestyle on Urinary Bisphenol A Levels in School-Aged Children of Southern Italy: A Pilot Study. Front Public Health. 2021 Feb 1;9:626070. doi: 10.3389/fpubh.2021.626070. eCollection 2021.

  PMID: 33598445 BACKGROUND

• Lange R, Vogel N, Schmidt P, Gerofke A, Luijten M, Bil W, Santonen T, Schoeters G, Gilles L, Sakhi AK, Haug LS, Jensen TK, Frederiksen H, Koch HM, Szigeti T, Szabados M, Tratnik JS, Mazej D, Gabriel C, Sarigiannis D, Dzhedzheia V, Karakitsios S, Rambaud L, Riou M, Koppen G, Covaci A, Zvonar M, Piler P, Klanova J, Fabelova L, Richterova D, Kosjek T, Runkel A, Pedraza-Diaz S, Verheyen V, Bastiaensen M, Esteban-Lopez M, Castano A, Kolossa-Gehring M. Cumulative risk assessment of five phthalates in European children and adolescents. Int J Hyg Environ Health. 2022 Sep;246:114052. doi: 10.1016/j.ijheh.2022.114052. Epub 2022 Oct 30. No abstract available.

  PMID: 36323174 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: August 3, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)