Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT07129434
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Universal Welch Emotional Connection Screen (uWECS)', 'timeFrame': 'From enrollment to the end of intervention and follow-up at 4 months', 'description': 'Emotional connection evaluated with the uWECS'}], 'secondaryOutcomes': [{'measure': "Mothers' mental health problems", 'timeFrame': 'From enrollment to end of intervention and follow-up 4 months', 'description': "Mothers' mental health problems are assessed with a range of standardized questionnaires using RedCap; higher scores mean worse outcomes."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome (PCOS)', 'Obesity &Amp;Amp; Overweight']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<9.0 at pre-test\n\nExclusion Criteria:\n\n\\- Infant death'}, 'identificationModule': {'nctId': 'NCT07129434', 'acronym': 'ECoFam', 'briefTitle': 'Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants', 'organization': {'class': 'OTHER', 'fullName': 'Oulu University Hospital'}, 'officialTitle': 'Strengthening Healthy Emotional Co-regulation of Mothers With PCOS and Obesity and Their Infants', 'orgStudyIdInfo': {'id': 'ECoFam PEPPI Pilot RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECoFam intervention', 'description': 'personalized coaching sessions', 'interventionNames': ['Behavioral: ECoFam']}, {'type': 'NO_INTERVENTION', 'label': 'treatment-as-usual (TAU)', 'description': 'control group, no intervention administered'}], 'interventions': [{'name': 'ECoFam', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['ECoFam intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jaana Nevalainen, MD PhD', 'role': 'CONTACT', 'email': 'Jaana.Nevalainen@oulu.fi', 'phone': '358405801857'}], 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'centralContacts': [{'name': 'Julia Jaekel, PhD', 'role': 'CONTACT', 'email': 'apfelliebhaber@gmail.com', 'phone': '358458043150'}], 'overallOfficials': [{'name': 'Julia Jäkel, Dr. phil. habil.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oulu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oulu University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oulu', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Julia Jaekel', 'investigatorAffiliation': 'Oulu University Hospital'}}}}