About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Unable to sign informed consent (cultural barriers, psychological conditions)
Abuse of substances (alcohol, drugs)
Antidepressants
Insuline.
Trial design
Treatments tested in this trial
- Multi-Component Behavioral intervention
- Control group
Treatment groups
Sponsors and collaborators
Fundació Institut Germans Trias i Pujol
Lead sponsor
KU Leuven
Collaborator
Universidad de Granada
Collaborator
Fundació Eurecat
Collaborator