NCT02900638

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

September 1, 2016

Last Update Submit

March 2, 2020

Conditions

Cardiovascular Health

Keywords

mentoringchildrencardiovascular health

Outcome Measures

Primary Outcomes (5)

  • 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

  • Blood Pressure

    Change in blood pressure from baseline to 8 months

  • Pro-inflammatory cytokines [standardized and averaged value of pro-inflammatory cytokines and CRP]

    Change in cytokine composite score from baseline to 8 months

  • Cholesterol

    Change in cholesterol from baseline to 8 months

  • HbA1c

    Change in HbA1c from baseline to 8 months

Study Arms (2)

Intervention (Mentor/Mentee)

EXPERIMENTAL
Behavioral: Mentoring

Wait list control

NO INTERVENTION

Interventions

MentoringBEHAVIORAL

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.

Intervention (Mentor/Mentee)

Eligibility Criteria

Age9 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 14, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

US(1)