Interpersonal Relationships Intervention and Cardiovascular Health
An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth
2 other identifiers
interventional
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2018
CompletedFirst Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
July 28, 2025
July 1, 2025
7.8 years
September 12, 2018
July 23, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Metabolic symptoms
Metabolic symptoms per International Diabetes Federation guidelines
Change in metabolic symptoms from baseline to approximately 1 year later
Flow-mediated vasodilation
Brachial artery diameter change
Change in flow-mediated vasodilation from baseline to approximately 1 year later
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance
Change in HOMA-IR score from baseline to approximately 1 year later
Secondary Outcomes (3)
Pro-inflammatory cytokines
Change from baseline to approximately 1 year later
Stimulated cytokine production
Change from baseline to approximately 1 year later
Glucocorticoid sensitivity
Change from baseline to approximately 1 year later
Study Arms (2)
Intervention (Mentor/Mentee)
EXPERIMENTALYouth 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.
Comparison group - written materials
ACTIVE COMPARATORYouth in the comparator group will receive written versions of all materials covered in the mentoring sessions.
Interventions
The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.
Written materials from the mentoring sessions will be provided to those in the comparison group
Eligibility Criteria
You may qualify if:
- undergraduate students for mentors
- Chicago Public School students for mentees
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Institutes of Health (NIH)collaborator
- DePaul Universitycollaborator
- University of Illinois at Chicagocollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Northwestern
Evanston, Illinois, 60208, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 13, 2018
Study Start
August 27, 2018
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share