Behavioral program to reduce endocrine-disrupting chemical exposure during pregnancy and early infancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CONTINUE tests a multicomponent behavioral intervention delivered through maternity and pediatric health centers across three European countries to reduce perinatal exposure to endocrine-disrupting chemicals. Pregnant participants are recruited in early pregnancy and randomized to receive the intervention or usual care, with partners invited but not required. The intervention combines education, behavior-change techniques based on the Health Action Process Approach (HAPA), and practical tools delivered via smartphones and in-person visits. Researchers will measure EDC levels in maternal and infant body fluids up to 18 months and track changes in HAPA psychological determinants and family knowledge about chemicals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)
* Being 18 years or older
* In possession of a smartphone. If participants do not have a smartphone because of socio-economic reasons, a smartphone will be at their disposal for the whole duration of the study

Exclusion Criteria:

* Unable to sign informed consent (cultural barriers, psychological conditions)
* Abuse of substances (alcohol, drugs)
* Chronic use (at least, for three months before pregnancy) of any medication that might affect the HP axis:
* Antidepressants
* Insuline.
* Levothyroxine, Methimazole, Propylthiouracil.
* Oral corticosteroids (topical and inhalation formulations will be allowed)
* Arginine vasopressin (AVP)
* Mifepristone.
* Anticortisolic drugs: Metyrapone (Metopirone), Ketokonazole, Osilodrostat (Isturisa), Mitotane (Lysodren), aminoglutethimide (Cytadren) and Levoketoconazole (Recorlev).
* Multiple gestation
* Type 1 or 2 diabetes
* Pregnant women will not be consented into research by any HCP with whom they have a dependent relationship (Declaration of Helsinki) (I would remove this point).

Where it's running

• Hospital Universitari Germans Trias i Pujol
  Badalona, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Inés Velasco, MD, PhD — Foundation Institute of Research in Health Sciences Germans Trias i Pujol
• Study coordinator: Inés Velasco, MD, PhD
• Email: ivelasco@igtp.cat
• Phone: + 34 696914449

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.