Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundació Institut Germans Trias i Pujol

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

810 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fundació Institut Germans Trias i Pujol

Lead sponsor

KU Leuven

Collaborator

Universidad de Granada

Collaborator

Fundació Eurecat

Collaborator