Interpersonal Relationships Intervention and Cardiovascular Health

Overview

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.

Full Title of Study: “An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2025

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.

Interventions

  • Behavioral: Mentoring
    • The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.
  • Behavioral: Comparison group – written materials
    • Written materials from the mentoring sessions will be provided to those in the comparison group

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Comparison group – written materials
    • Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions.

Clinical Trial Outcome Measures

Primary Measures

  • Metabolic symptoms
    • Time Frame: Change in metabolic symptoms from baseline to approximately 1 year later
    • Metabolic symptoms per International Diabetes Federation guidelines
  • Flow-mediated vasodilation
    • Time Frame: Change in flow-mediated vasodilation from baseline to approximately 1 year later
    • Brachial artery diameter change
  • HOMA-IR
    • Time Frame: Change in HOMA-IR score from baseline to approximately 1 year later
    • Homeostatic Model Assessment of Insulin Resistance

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • undergraduate students for mentors – Chicago Public School students for mentees Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Edith Chen, Professor – Northwestern University
  • Overall Contact(s)
    • Edith Chen, 8474670366, edith.chen@northwestern.edu

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