Interpersonal Relationships Intervention and Cardiovascular Health

An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Health
• Intervention / Treatment: Behavioral: Mentoring; Behavioral: Comparison group - written materials

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• undergraduate students for mentors
• Chicago Public School students for mentees

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Mentor/Mentee); 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.	Behavioral: Mentoring; The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.
Active Comparator: Comparison group - written materials; Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions.	Behavioral: Comparison group - written materials; Written materials from the mentoring sessions will be provided to those in the comparison group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory cytokines	Standardized and averaged values of pro-inflammatory cytokines + CRP	Change from baseline to approximately 1 year later
Stimulated cytokine production	Standardized and averaged values of stimulated pro-inflammatory cytokines	Change from baseline to approximately 1 year later
Glucocorticoid sensitivity	Standardized and averaged values of cytokine production after stimulation plus addition of cortisol	Change from baseline to approximately 1 year later

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Illinois at Chicago; National Institutes of Health (NIH); DePaul University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): August 21, 2025
• Study Completion (Actual): August 21, 2025

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 00203223; R01HL136676 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No