Cardiovascular HealthNCT02900638
Health Effects of Mentoring
A study testing Mentoring in people with Cardiovascular Health, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether mentoring is associated with beneficial cardiovascular health effects in both mentors and mentees. Read more about this study
- Who is it for?
- Ages 9 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Undergraduate student for mentors.
- Chicago Public School student for mentees.
Who cannot join
- Younger than 9 or older than 14 for mentee conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiovascular Health
- Being tested
- Mentoring
- Keywords
- mentoring, children, cardiovascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Mentor/Mentee) | Experimental | Not described Receives: Behavioral: Mentoring |
| Wait list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity [body mass index]
BMI in kg/m^2, weight in kilograms, height in meters
Measured: Change in body mass index from baseline to 8 months
Blood Pressure
Measured: Change in blood pressure from baseline to 8 months
Pro-inflammatory cytokines [standardized and averaged value of pro-inflammatory cytokines and CRP]
Measured: Change in cytokine composite score from baseline to 8 months
Cholesterol
Measured: Change in cholesterol from baseline to 8 months
HbA1c
Measured: Change in HbA1c from baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edith Chen, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900638
- Sponsor's protocol ID
- STU00203223
- Status last verified
- Mar 2020
- First submitted
- 1 Sep 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Physical Health Effects of Cities Mentor Project
- ClinicalTrials.gov ID
- NCT02900638
- Acronym / sponsor ID
- STU00203223
- Conditions
- Cardiovascular Health
- Keywords
- mentoring, children, cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether mentoring is associated with beneficial cardiovascular health effects in both mentors and mentees.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Mentor/Mentee) | Experimental | Behavioral: Mentoring |
| Wait list control | No intervention | – |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Undergraduate student for mentors.
- Chicago Public School student for mentees.
Key exclusion criteria (1 listed)
- Younger than 9 or older than 14 for mentee conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MentoringYouth 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. | Behavioural | Intervention (Mentor/Mentee) |
Primary outcome
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
Blood Pressure
Time frame: 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
Cholesterol
Time frame: Change in cholesterol from baseline to 8 months
HbA1c
Time frame: Change in HbA1c from baseline to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentoring in people with Cardiovascular Health, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity [body mass index] (time frame: Change in body mass index from baseline to 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.