Interpersonal Relationships Intervention and Cardiovascular Health

NCT ID: NCT03670368

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mentoring

Intervention Type 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

Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions.

Group Type ACTIVE_COMPARATOR

Comparison group - written materials

Intervention Type BEHAVIORAL

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

Interventions

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Mentoring

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

Intervention Type BEHAVIORAL

Comparison group - written materials

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

DePaul University

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Edith Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern

Evanston, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Edith Chen

Role: CONTACT

8474670366

Facility Contacts

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Edith Chen

Role: primary

8474670366

Other Identifiers

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R01HL136676

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00203223

Identifier Type: -

Identifier Source: org_study_id

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