Interpersonal Relationships Intervention and Cardiovascular Health

Study Overview
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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.

Official Title
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An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth

Conditions
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Cardiovascular Health

Intervention / Treatment
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* Behavioral: Mentoring
* Behavioral: Comparison group - written materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergraduate students for mentors Chicago Public School students for mentees Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |