- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02900638
Health Effects of Mentoring
March 2, 2020 updated by: Edith Chen, Northwestern University
Pilot Study of Physical Health Effects of Cities Mentor Project
The purpose of this study is to determine whether mentoring is associated with beneficial cardiovascular health effects in both mentors and mentees.
Study Overview
Detailed 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
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60208
- Northwestern University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Wait list control
|
|
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Experimental: 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 the development of a social bond between mentor and mentee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obesity [body mass index]
Time Frame: Change in body mass index from baseline to 8 months
|
BMI in kg/m^2, weight in kilograms, height in meters
|
Change in body mass index from baseline to 8 months
|
|
Blood Pressure
Time Frame: Change in blood pressure from baseline to 8 months
|
Change in blood pressure from baseline to 8 months
|
|
|
Pro-inflammatory cytokines [standardized and averaged value of pro-inflammatory cytokines and CRP]
Time Frame: Change in cytokine composite score from baseline to 8 months
|
Change in cytokine composite score from baseline to 8 months
|
|
|
Cholesterol
Time Frame: Change in cholesterol from baseline to 8 months
|
Change in cholesterol from baseline to 8 months
|
|
|
HbA1c
Time Frame: Change in HbA1c from baseline to 8 months
|
Change in HbA1c from baseline to 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
August 1, 2019
Study Registration Dates
First Submitted
September 1, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (Estimate)
September 14, 2016
Study Record Updates
Last Update Posted (Actual)
March 4, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STU00203223
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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