The general objective of HYPIEND is to understand the effects of chemical substances called "endocrine disruptors" (EDCs) during the perinatal and pre-pubertal stages. EDCs co-exposure may affect the function of hormones and determine endocrine consequences in vulnerable populations.
The primary objective of this clinical study is to demonstrate that a multicomponent intervention implemented in health care centres from three European countries is effective in reducing the levels of EDCs in different body fluids of pregnant women, breastfeeding and formula feeding women as well as in their infants up to 18 months of age, improving at the same time the level of HAPA constructs (psychological determinants of behaviour) and the knowledge about these chemicals at family level.
Pregnant women with a viable pregnancy confirmed by ultrasound until 13 weeks and 0 days of gestation (recruitment between 6-11 weeks). Their partners will be invited to participate but this is not mandatory for inclusion.
BMI at Visit 1 between 18.5-40 kg/m²
Intention to breastfeed
Being able to read the language of their respective countries (Dutch/French -Belgium-, Spanish and/or Catalan -Spain- and Polish -Poland)
Unable to sign informed consent (cultural barriers, psychological conditions)
Abuse of substances (alcohol, drugs)
Antidepressants
Insuline.
Parallel
Multi-Component Behavioral intervention
BehavioralA multicomponent behavioral intervention during pregnancy and up to the first 18 months after delivery, composed by: 1. Digital tool called "App Hypiend Digital Tool" aimed at promoting lifestyle habits to reduce EDC exposure by providing personalized recommendations 2. Telephone monitoring 3. Workshop about environmental health education
Control group
BehavioralMinimal behavioral intervention. Usual care
Decrease of mono(2-ethyl-5-oxohexyl) phthalate (MEOHP) concentration in urine
This election was based on a scientific article in which was reported that mental and/or Psychomotor Developmental Indices of the Bayley Scales of Infant Development were inversely correlated in 6-month-old infants with the maternal urinary levels of MEHHP and MEOHP at the third trimester of pregnancy in a study carried out with 460 mother-infant pairs (4). However, since during the initial phase of the project a predictive modelling approach will be carried out in order to select the EDC mixtures with high harmful effects to be evaluated in preclinical models, the definitive main outcome could be redefined once we obtain the predictive modelling results. We would expect to detect a 25% decrease in the urinary levels of MEOHP in the intervention group vs control group at the end of the study.
Reduction of EDC levels in biological fluids
Other EDCs in urine, peripheral blood, cord blood and milk
Click on the lead sponsor to view all of their trials.
Fundació Institut Germans Trias i Pujol
Lead sponsor
KU Leuven
Collaborator
Universidad de Granada
Collaborator
Fundació Eurecat
Collaborator
