Understanding and Preventing the Impact of Endocrine Disruptors on the Hypothalamus-pituitary Axis in Sensitive Populations: Study of the Effects of a School and Parental Policy to Minimize Exposure to Endocrine Disruptors Among 6 and 8 Year-olds in the Wallonia-Brussels Federation and Catalunya (Hypiend-PPC)

NCT07411001 NA ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Sciensano
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	700
Start date	2025-09-15
Completion	2028-12

Conditions

• Precocious Puberty, Central
• Executive Dysfunction

Interventions

• Multi-Component Behavioral intervention
• Information

Primary outcomes

• Change in urinary concentration of BPA — From enrollment to the end of the intervention at 26 months
  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.

Countries

Belgium