[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602893":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":56,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":22,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":18,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Oulu University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ECoFam intervention","EXPERIMENTAL","personalized coaching sessions",[13],"Behavioral: ECoFam",{"label":15,"type":16,"description":17,"interventionNames":18},"treatment-as-usual (TAU)","NO_INTERVENTION","control group, no intervention administered",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","ECoFam","Mother-infant dyads randomized into the intervention group receive four personal coaching sessions to facilitate emotional connection via multisensory channels including comfort touch and communication of face-to-face affect during holding time.",[9],[26],{"name":27,"affiliation":28,"role":29},"Julia Jäkel, Dr. phil. habil.","University of Oulu","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Julia Jaekel, PhD","CONTACT","358458043150","apfelliebhaber@gmail.com",[37],{"facility":5,"status":38,"city":39,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Oulu","Finland","FI",{"type":43,"coordinates":44},"Point",[45,46],25.46816,65.01236,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":18,"email":52},"Jaana Nevalainen, MD PhD","358405801857","Jaana.Nevalainen@oulu.fi",{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Julia Jaekel","Prof. Dr.",[57],{"name":28,"class":6},"100602893","strengthening-healthy-emotional-co-regulation-of-mothers-with-pcos-and-obesity-and-their-infants-100602893",false,"NCT07129434","Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants","Inclusion Criteria:\n\n* Diagnosis of PCOS\n* Obesity according to BMI\n* Gave birth at Oulu University Hospital in 2024-25\n* PEPPI cohort study participation\n* uWECS emotional connection score \\\u003C9.0 at pre-test\n\nExclusion Criteria:\n\n\\- Infant death","FEMALE",{"count":66,"type":67},40,"ESTIMATED","INTERVENTIONAL",[70],"NA","It is both timely and important to invest in interventions that can improve healthy emotional co-regulation. It is proposed to evaluate the feasibility and limited efficacy of an adapted, brief, multimodal intervention: ECoFam (Emotional connection and Co-regulation for Families). Evidence from the US suggests intervention effects on maternal and infant outcomes that are large in effect size (i.e., Cohen's d \\>0.6 for increasing emotional connection and decreasing maternal depressive symptoms) (21-23). The study results will directly translate evidence into practice and, if found feasible, allow rapid scaling-up.\n\nObjectives:\n\n1. Build capacity for implementation of a novel diagnostic screening tool for emotional co-regulation, the uWECS, as part of clinical follow-up for mother-infant dyads with high fibrobesity risk in Finland.\n2. Test the feasibility and limited efficacy of the brief, multimodal ECoFam intervention to foster healthy emotional co-regulation between mothers with PCOS and obesity and their infants.",[73,74],"Polycystic Ovary Syndrome (PCOS)","Obesity &Amp;Amp; Overweight","2025-08-11",{"date":77,"type":78},"2025-08-19","ACTUAL",{"date":80,"type":78},"2025-04-15",{"date":82,"type":67},"2026-12",{"name":5,"class":6},1]