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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02900638
Other study ID # STU00203223
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016

Study information

Verified date March 2020
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether mentoring is associated with beneficial cardiovascular health effects in both mentors and mentees.


Description:

Participants are randomly assigned to either being a mentor or a wait list control. These participants are drawn from a population of undergraduate students. Participants are also randomly assigned to either being a mentee or a wait list control. These participants are drawn from a population of Chicago Public School children. In total, there will be 30 mentors, 30 control mentors, 30 mentees, and 30 control mentees. 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. The protocol will be the same at the two study visits. Participants in the intervention group will engage in one-on-one mentoring sessions (between mentors and mentees) once a week after school for the school year


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date
Est. primary completion date August 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 25 Years
Eligibility Inclusion Criteria:

- Undergraduate student for mentors.

- Chicago Public School student for mentees.

Exclusion Criteria:

- Younger than 9 or older than 14 for mentee conditions.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 the development of a social bond between mentor and mentee.

Locations

Country Name City State
United States Northwestern University Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Obesity [body mass index] BMI in kg/m^2, weight in kilograms, height in meters Change in body mass index from baseline to 8 months
Primary Blood Pressure Change in blood pressure from baseline to 8 months
Primary Pro-inflammatory cytokines [standardized and averaged value of pro-inflammatory cytokines and CRP] Change in cytokine composite score from baseline to 8 months
Primary Cholesterol Change in cholesterol from baseline to 8 months
Primary HbA1c Change in HbA1c from baseline to 8 months
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