Interpersonal Relationships Intervention and Cardiovascular Health

Cardiovascular Health Clinical Trial

Official title:

An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670368
• Other study ID #: 00203223
• Secondary ID: R01HL136676
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: May 31, 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Edith Chen
• Phone: 8474670366
• Email: edith.chen[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

• undergraduate students for mentors

• Chicago Public School students for mentees

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cardiovascular Health

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern	Evanston	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	DePaul University, National Institutes of Health (NIH), University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic symptoms	Metabolic symptoms per International Diabetes Federation guidelines	Change in metabolic symptoms from baseline to approximately 1 year later
Primary	Flow-mediated vasodilation	Brachial artery diameter change	Change in flow-mediated vasodilation from baseline to approximately 1 year later
Primary	HOMA-IR	Homeostatic Model Assessment of Insulin Resistance	Change in HOMA-IR score from baseline to approximately 1 year later
Secondary	Pro-inflammatory cytokines	Standardized and averaged values of pro-inflammatory cytokines + CRP	Change from baseline to approximately 1 year later
Secondary	Stimulated cytokine production	Standardized and averaged values of stimulated pro-inflammatory cytokines	Change from baseline to approximately 1 year later
Secondary	Glucocorticoid sensitivity	Standardized and averaged values of cytokine production after stimulation plus addition of cortisol	Change from baseline to approximately 1 year later