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Health Effects of Mentoring

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ClinicalTrials.gov Identifier: NCT02900638
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Edith Chen, Northwestern University

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

Condition or disease Intervention/treatment Phase
Cardiovascular Health Behavioral: Mentoring Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study of Physical Health Effects of Cities Mentor Project
Study Start Date : August 2016
Estimated Primary Completion Date : August 2019

Arm Intervention/treatment
Experimental: Intervention (Mentor/Mentee) 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.

No Intervention: Wait list control



Primary Outcome Measures :
  1. 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

  2. Blood Pressure [ Time Frame: Change in blood pressure from baseline to 8 months ]
  3. 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 ]
  4. Cholesterol [ Time Frame: Change in cholesterol from baseline to 8 months ]
  5. HbA1c [ Time Frame: Change in HbA1c from baseline to 8 months ]


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Ages Eligible for Study:   9 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Undergraduate student for mentors.
  • Chicago Public School student for mentees.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900638


Contacts
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Contact: Edith Chen, PhD edith.chen@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Edith Chen, PhD       edith.chen@northwestern.edu   
Sponsors and Collaborators
Northwestern University

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Responsible Party: Edith Chen, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02900638     History of Changes
Other Study ID Numbers: STU00203223
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Edith Chen, Northwestern University:
mentoring
children
cardiovascular health