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OpenTrials
Completed

NCT Number: NCT03670368

Interpersonal Relationships Intervention and Cardiovascular Health

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.

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Key information

Conditions

Cardiovascular Health

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern

Evanston, Illinois, 60208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Mentoring

Behavioral

The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.

Comparison group - written materials

Behavioral

Written materials from the mentoring sessions will be provided to those in the comparison group

Primary outcomes

  1. Metabolic symptoms

    Time frame: Change in metabolic symptoms from baseline to approximately 1 year later

    Metabolic symptoms per International Diabetes Federation guidelines

  2. Flow-mediated vasodilation

    Time frame: Change in flow-mediated vasodilation from baseline to approximately 1 year later

    Brachial artery diameter change

  3. HOMA-IR

    Time frame: Change in HOMA-IR score from baseline to approximately 1 year later

    Homeostatic Model Assessment of Insulin Resistance

Secondary outcomes

  1. Pro-inflammatory cytokines

    Time frame: Change from baseline to approximately 1 year later

    Standardized and averaged values of pro-inflammatory cytokines + CRP

  2. Stimulated cytokine production

    Time frame: Change from baseline to approximately 1 year later

    Standardized and averaged values of stimulated pro-inflammatory cytokines

  3. 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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Official study title

An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2018
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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