Interpersonal Relationships Intervention and Cardiovascular Health

Not Applicable

Recruiting

• Conditions: Cardiovascular Health
• Interventions: Behavioral: Comparison group - written materials; Behavioral: Mentoring

• Registration Number: NCT03670368
• Lead Sponsor: Northwestern University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-27
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison group - written materials	Comparison group - written materials	Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions.
Intervention (Mentor/Mentee)	Mentoring	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern; 🇺🇸 Evanston, Illinois, United States