Cardiovascular HealthNCT03670368
Interpersonal Relationships Intervention and Cardiovascular Health
A study testing Mentoring and Comparison group - written materials 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 random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Mentoring and Comparison group - written materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 21 Aug 2025
- 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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- undergraduate students for mentors
- Chicago Public School students for mentees
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth
The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.
Read the detailed description
Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. 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. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.
- Conditions
- Cardiovascular Health
- Being tested
- Mentoring, Comparison group - written materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentoringBehavioural
The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.
Comparison group - written materialsBehavioural
Written materials from the mentoring sessions will be provided to those in the comparison group
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Mentor/Mentee) | Experimental | 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 social relationships, coping behaviors, and healthy lifestyles. Receives: Behavioral: Mentoring |
| Comparison group - written materials | Active comparator | Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions. Receives: Behavioral: Comparison group - written materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic symptoms
Metabolic symptoms per International Diabetes Federation guidelines
Measured: Change in metabolic symptoms from baseline to approximately 1 year later
Flow-mediated vasodilation
Brachial artery diameter change
Measured: Change in flow-mediated vasodilation from baseline to approximately 1 year later
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance
Measured: Change in HOMA-IR score from baseline to approximately 1 year later
Secondary outcomes (3)
Pro-inflammatory cytokines
Standardized and averaged values of pro-inflammatory cytokines + CRP
Measured: Change from baseline to approximately 1 year later
Stimulated cytokine production
Standardized and averaged values of stimulated pro-inflammatory cytokines
Measured: Change from baseline to approximately 1 year later
Glucocorticoid sensitivity
Standardized and averaged values of cytokine production after stimulation plus addition of cortisol
Measured: Change from baseline to approximately 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start27 Aug 2018
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
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
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), DePaul University, University of Illinois Chicago, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Edith Chen, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670368
- Sponsor's protocol ID
- 00203223
- Other IDs
- R01HL136676
- Status last verified
- May 2026
- First submitted
- 12 Sep 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth
- ClinicalTrials.gov ID
- NCT03670368
- Acronym / sponsor ID
- 00203223
- Conditions
- Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), DePaul University, University of Illinois Chicago, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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 random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.
Detailed description
Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. 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. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.
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: 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 social relationships, coping behaviors, and healthy lifestyles. |
| Comparison group - written materials | Active comparator | Behavioral: Comparison group - written materialsYouth in the comparator group will receive written versions of all materials covered in the mentoring sessions. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- undergraduate students for mentors
- Chicago Public School students for mentees
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MentoringThe intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles. | Behavioural | Intervention (Mentor/Mentee) |
| Comparison group - written materialsWritten materials from the mentoring sessions will be provided to those in the comparison group | Behavioural | Comparison group - written materials |
Primary outcome
Metabolic symptoms
Time frame: Change in metabolic symptoms from baseline to approximately 1 year later
Metabolic symptoms per International Diabetes Federation guidelines
Flow-mediated vasodilation
Time frame: Change in flow-mediated vasodilation from baseline to approximately 1 year later
Brachial artery diameter change
HOMA-IR
Time frame: Change in HOMA-IR score from baseline to approximately 1 year later
Homeostatic Model Assessment of Insulin Resistance
3 secondary outcomes
Pro-inflammatory cytokines
Time frame: Change from baseline to approximately 1 year later
Stimulated cytokine production
Time frame: Change from baseline to approximately 1 year later
Glucocorticoid sensitivity
Time frame: Change from baseline to approximately 1 year later
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 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Health
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
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 and Comparison group - written materials 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 1 Jun 2026. 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?
Metabolic symptoms (time frame: Change in metabolic symptoms from baseline to approximately 1 year later). The study lists 3 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 1 Jun 2026.