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

NCT07142447 | Recruiting DMC

• 1 other identifier: 101137440
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pregnancy; Children

Keywords

Endocrine Disruptors; hormones

Outcome Measures

Primary Outcomes (1)

• Decrease of mono(2-ethyl-5-oxohexyl) phthalate (MEOHP) concentration in urine

  This election was based on a scientific article in which was reported that mental and/or Psychomotor Developmental Indices of the Bayley Scales of Infant Development were inversely correlated in 6-month-old infants with the maternal urinary levels of MEHHP and MEOHP at the third trimester of pregnancy in a study carried out with 460 mother-infant pairs (4). However, since during the initial phase of the project a predictive modelling approach will be carried out in order to select the EDC mixtures with high harmful effects to be evaluated in preclinical models, the definitive main outcome could be redefined once we obtain the predictive modelling results. We would expect to detect a 25% decrease in the urinary levels of MEOHP in the intervention group vs control group at the end of the study.

  From first trimester of pregnancy to 18 months after delivery

Other Outcomes (1)

• Reduction of EDC levels in biological fluids

  From first trimester of pregnancy to 18 months after delivery

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

Healthy pregnant women who will receive a multi-component behavioral intervention (digital tool aimed at promoting lifestyle habits to reduce EDC exposure by providing personalized recommendations + telephone monitoring + workshops about environmental health education) during pregnancy and the first 18 months after delivery.

Behavioral: Multi-Component Behavioral intervention

Control group

OTHER

Healthy pregnant women who will receive the standard of care. The control condition consists of a single online education module/written information about EDCs addressed to reduce their exposure. They will also have access to the digital tool to answer the questionnaires, but this group will not receive any recommendations or missions from the professionals concerning EDCs along the study. After finishing the intervention, the participants of the control group will be offered access to all the developed material (workshops…) and to use the app.

Behavioral: Control group

Interventions

Multi-Component Behavioral intervention BEHAVIORAL

A multicomponent behavioral intervention during pregnancy and up to the first 18 months after delivery, composed by: 1. Digital tool called "App Hypiend Digital Tool" aimed at promoting lifestyle habits to reduce EDC exposure by providing personalized recommendations 2. Telephone monitoring 3. Workshop about environmental health education

Behavioral intervention

Control group BEHAVIORAL

Minimal behavioral intervention. Usual care

Also known as: Minimal behavioral intervention. Usual care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• KU Leuven: collaborator
• Universidad de Granada: collaborator
• Fundació Eurecat: collaborator

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (3)

• Schulz MC, Sargis RM. Inappropriately sweet: Environmental endocrine-disrupting chemicals and the diabetes pandemic. Adv Pharmacol. 2021;92:419-456. doi: 10.1016/bs.apha.2021.04.002. Epub 2021 Jun 9.

  PMID: 34452693 BACKGROUND

• Heindel JJ, Howard S, Agay-Shay K, Arrebola JP, Audouze K, Babin PJ, Barouki R, Bansal A, Blanc E, Cave MC, Chatterjee S, Chevalier N, Choudhury M, Collier D, Connolly L, Coumoul X, Garruti G, Gilbertson M, Hoepner LA, Holloway AC, Howell G 3rd, Kassotis CD, Kay MK, Kim MJ, Lagadic-Gossmann D, Langouet S, Legrand A, Li Z, Le Mentec H, Lind L, Monica Lind P, Lustig RH, Martin-Chouly C, Munic Kos V, Podechard N, Roepke TA, Sargis RM, Starling A, Tomlinson CR, Touma C, Vondracek J, Vom Saal F, Blumberg B. Obesity II: Establishing causal links between chemical exposures and obesity. Biochem Pharmacol. 2022 May;199:115015. doi: 10.1016/j.bcp.2022.115015. Epub 2022 Apr 5.

  PMID: 35395240 BACKGROUND

• O'Shaughnessy KL, Fischer F, Zenclussen AC. Perinatal exposure to endocrine disrupting chemicals and neurodevelopment: How articles of daily use influence the development of our children. Best Pract Res Clin Endocrinol Metab. 2021 Sep;35(5):101568. doi: 10.1016/j.beem.2021.101568. Epub 2021 Sep 4.

  PMID: 34565681 BACKGROUND

Related Links

• Official website of the interventional study

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Inés Velasco, MD, PhD

  Foundation Institute of Research in Health Sciences Germans Trias i Pujol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inés Velasco, MD, PhD

CONTACT

+ 34 696914449; ivelasco@igtp.cat

Magí Farré, MD, PhD

CONTACT

+34 93 497 89 74; mfarre.germanstrias@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HYPIEND aims at evaluating whether a multi-centric, multicomponent interventional trial (digital tool aimed at promoting lifestyle habits to reduce EDC exposure by providing personalized recommendations + phone calls + workshops about environmental health education) carried out in 810 women from pregnancy until their children are 18 months old is able to reduce the exposure to different EDCs. This intervention will be designed considering the gradual introduction of small changes (i.e., by using goal setting), carrying out a family-based approach, in a personalized manner, considering targeting different routes of exposure and providing to the participants frequent feedback and support. With this design, we expect to promote a behavioural change to achieve long-lasting effects in reducing the exposure to EDCs. The effects will be compared with a control intervention group, which will only receive a digital printable booklet with information on EDC hazards.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 26, 2025
• Study Start: February 24, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)