Behavioral program to reduce endocrine-disrupting chemical exposure during pregnancy and early infancy
Understanding and Preventing the Impact of Endocrine Disruptors on the Hypothalamus-pituitary Axis in Sensitive Populations. Hypiend- Perinatal Study.
This project will try a behavioral program for pregnant people to lower their and their babies' exposure to endocrine-disrupting chemicals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 810 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundació Institut Germans Trias i Pujol Academic / other |
| Locations | 1 site (Badalona, Barcelona) |
| Trial ID | NCT07142447 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a viable pregnancy enrolled by 13 weeks, BMI 18.5–40 kg/m², intending to breastfeed, able to read the local language and able to use (or be provided with) a smartphone are ideal candidates.
Not a fit: People who cannot give informed consent, have substance abuse, are on chronic medications that affect the hypothalamic–pituitary axis, or cannot attend visits or use the smartphone tools are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could lower chemical exposures in mothers and infants and potentially reduce risks to infant growth and development.
How similar studies have performed: Epidemiological studies link EDC exposure to developmental outcomes and small behavior-change trials have reduced some chemical exposures, but large multicenter interventions targeting perinatal EDC exposure are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Badalona, Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.