Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07142447

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

Led by Fundació Institut Germans Trias i Pujol · Updated on 2025-08-26

810

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

F

Fundació Institut Germans Trias i Pujol

Lead Sponsor

K

KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women with a viable pregnancy confirmed by ultrasound up to 13 weeks and 0 days of gestation (recruitment between 6-11 weeks)
  • Body mass index (BMI) between 18.5 and 40 kg/m² at first visit
  • Intention to breastfeed
  • Ability to read the language of their respective country (Dutch/French in Belgium, Spanish and/or Catalan in Spain, Polish in Poland)
  • At least 18 years old
  • Possession of a smartphone or willingness to use one provided due to socioeconomic reasons
Not Eligible

You will not qualify if you...

  • Unable to give informed consent due to cultural or psychological reasons
  • Substance abuse (alcohol or drugs)
  • Chronic use (at least 3 months before pregnancy) of medications that may affect the hypothalamus-pituitary axis, including antidepressants, insulin, levothyroxine, methimazole, propylthiouracil, oral corticosteroids (topical and inhalation allowed), arginine vasopressin, mifepristone, and anti-cortisolic drugs like metyrapone, ketoconazole, osilodrostat, mitotane, aminoglutethimide, and levoketoconazole
  • Multiple pregnancy (twins or more)
  • Type 1 or type 2 diabetes
  • Pregnant women with a dependent relationship to any healthcare professional involved in the research (per Declaration of Helsinki)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

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Research Team

I

Inés Velasco, MD, PhD

CONTACT

M

Magí Farré, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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