Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-20 @ 6:37 PM
Study NCT ID:
NCT03670368
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2018-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interpersonal Relationships Intervention and Cardiovascular Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic symptoms', 'timeFrame': 'Change in metabolic symptoms from baseline to approximately 1 year later', 'description': 'Metabolic symptoms per International Diabetes Federation guidelines'}, {'measure': 'Flow-mediated vasodilation', 'timeFrame': 'Change in flow-mediated vasodilation from baseline to approximately 1 year later', 'description': 'Brachial artery diameter change'}, {'measure': 'HOMA-IR', 'timeFrame': 'Change in HOMA-IR score from baseline to approximately 1 year later', 'description': 'Homeostatic Model Assessment of Insulin Resistance'}], 'secondaryOutcomes': [{'measure': 'Pro-inflammatory cytokines', 'timeFrame': 'Change from baseline to approximately 1 year later', 'description': 'Standardized and averaged values of pro-inflammatory cytokines + CRP'}, {'measure': 'Stimulated cytokine production', 'timeFrame': 'Change from baseline to approximately 1 year later', 'description': 'Standardized and averaged values of stimulated pro-inflammatory cytokines'}, {'measure': 'Glucocorticoid sensitivity', 'timeFrame': 'Change from baseline to approximately 1 year later', 'description': 'Standardized and averaged values of cytokine production after stimulation plus addition of cortisol'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Health']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.', 'detailedDescription': 'Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergraduate students for mentors\n* Chicago Public School students for mentees\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03670368', 'briefTitle': 'Interpersonal Relationships Intervention and Cardiovascular Health', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth', 'orgStudyIdInfo': {'id': '00203223'}, 'secondaryIdInfos': [{'id': 'R01HL136676', 'link': 'https://reporter.nih.gov/quickSearch/R01HL136676', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Mentor/Mentee)', 'description': 'Youth in the intervention group will participate in one-on-one mentoring sessions (between mentors and mentees) once per week after school. Mentoring sessions will focus on social relationships, coping behaviors, and healthy lifestyles.', 'interventionNames': ['Behavioral: Mentoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison group - written materials', 'description': 'Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions.', 'interventionNames': ['Behavioral: Comparison group - written materials']}], 'interventions': [{'name': 'Mentoring', 'type': 'BEHAVIORAL', 'description': 'The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.', 'armGroupLabels': ['Intervention (Mentor/Mentee)']}, {'name': 'Comparison group - written materials', 'type': 'BEHAVIORAL', 'description': 'Written materials from the mentoring sessions will be provided to those in the comparison group', 'armGroupLabels': ['Comparison group - written materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edith Chen', 'role': 'CONTACT', 'email': 'edith.chen@northwestern.edu', 'phone': '8474670366'}], 'facility': 'Northwestern', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'centralContacts': [{'name': 'Edith Chen', 'role': 'CONTACT', 'email': 'edith.chen@northwestern.edu', 'phone': '8474670366'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'DePaul University', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Edith Chen', 'investigatorAffiliation': 'Northwestern University'}}}}