[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603894":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":25,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fundació Institut Germans Trias i Pujol","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Multi-Component Behavioral intervention",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","Healthy pregnant women who will receive the standard of care. The control condition consists of a single online education module\u002Fwritten 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.",[18],"Behavioral: Control group",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Multi-Component Behavioral intervention","A multicomponent behavioral intervention during pregnancy and up to the first 18 months after delivery, composed by:\n\n1. Digital tool called \"App Hypiend Digital Tool\" aimed at promoting lifestyle habits to reduce EDC exposure by providing personalized recommendations\n2. Telephone monitoring\n3. Workshop about environmental health education",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Minimal behavioral intervention. Usual care",[15],[27],[31],{"name":32,"affiliation":33,"role":34},"Inés Velasco, MD, PhD","Foundation Institute of Research in Health Sciences Germans Trias i Pujol","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+ 34 696914449","ivelasco@igtp.cat",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Magí Farré, MD, PhD","+34 93 497 89 74","mfarre.germanstrias@gencat.cat",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hospital Universitari Germans Trias i Pujol","RECRUITING","Badalona","Barcelona","08916","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],2.24741,41.45004,{"lat":57,"lon":56},[60],{"name":32,"role":37,"phone":61,"phoneExt":25,"email":39},"+34 696914449",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65,67,69],{"name":66,"class":6},"KU Leuven",{"name":68,"class":6},"Universidad de Granada",{"name":70,"class":6},"Fundació Eurecat","100603894","effectiveness-of-a-multicomponent-behavioural-intervention-to-reduce-endocrine-disruptor-exposure-during-perinatal-period-continue-100603894",false,"NCT07142447","Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)","Understanding and Preventing the Impact of Endocrine Disruptors on the Hypothalamus-pituitary Axis in Sensitive Populations. Hypiend- Perinatal Study.","CONTINUE","Inclusion Criteria:\n\n* 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.\n* BMI at Visit 1 between 18.5-40 kg\u002Fm²\n* Intention to breastfeed\n* Being able to read the language of their respective countries (Dutch\u002FFrench -Belgium-, Spanish and\u002For Catalan -Spain- and Polish -Poland)\n* Being 18 years or older\n* 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\n\nExclusion Criteria:\n\n* Unable to sign informed consent (cultural barriers, psychological conditions)\n* Abuse of substances (alcohol, drugs)\n* Chronic use (at least, for three months before pregnancy) of any medication that might affect the HP axis:\n* Antidepressants\n* Insuline.\n* Levothyroxine, Methimazole, Propylthiouracil.\n* Oral corticosteroids (topical and inhalation formulations will be allowed)\n* Arginine vasopressin (AVP)\n* Mifepristone.\n* Anticortisolic drugs: Metyrapone (Metopirone), Ketokonazole, Osilodrostat (Isturisa), Mitotane (Lysodren), aminoglutethimide (Cytadren) and Levoketoconazole (Recorlev).\n* Multiple gestation\n* Type 1 or 2 diabetes\n* 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).","FEMALE","18 Years",{"count":82,"type":83},810,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.\n\nThe 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.",[89,90],"Pregnancy","Children",[92,93],"Endocrine Disruptors","hormones","2025-08-22",{"date":96,"type":97},"2025-08-26","ACTUAL",{"date":99,"type":97},"2025-02-24",{"date":101,"type":83},"2027-07",{"name":5,"class":6},1]