Diabetes MellitusNCT06430203
Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program
A study testing Peer mentoring in people with Diabetes Mellitus and Distress, Emotional, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The goal of this study is to learn if an Indigenous led peer-mentor program can provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. Also, we will learn about Indigenous youth and young adults experience with diabetes. Read more about this study
- Who is it for?
- Ages 10 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Distress, Emotional
- What is being tested?
- Peer mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 10-29 years old Clinical diagnosis of diabetes or gestational diabetes
Who cannot join
- Age > 29 years old Not at risk of diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this study is to learn if an Indigenous led peer-mentor program can provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. Also, we will learn about Indigenous youth and young adults experience with diabetes.
- Can a peer-mentoring program reduce diabetes distress among Indigenous youth and young adults with diabetes?
- What is it like for Indigenous youth and young adults to be live with diabetes?
- Can a peer-mentoring program reduce global distress and improve resilience among Indigenous youth and young adults with diabetes?
- Can a peer-mentoring program lead to changes in lifestyle (diet, physical activity, substance use) and diabetes related clinical outcomes among Indigenous youth and young adults with diabetes.
Read more
Researchers will compare distress, resilience, lifestyles, and diabetes related clinical outcomes before participating in the peer-mentoring program and at 6 and 12 months into the program. Additionally, participants will be asked to share their journey with diabetes through photos throughout the program
Participants will:
- Be paired with peer-mentors who also have diabetes and they will share their journey with diabetes
- Participate in activities (grocery tours, walking clubs, land-based activities, cooking classes) held by peer-mentors
- Complete questionnaires on distress, resilience, and lifestyle every 6 months.
- Participate in Photovoice workshops to share their stories through pictures.
Read the detailed description
The rates of diabetes are increasing among youth and young adults. This rise is particularly steep among Indigenous peoples who also face high rates of depression and emotional distress due to the ongoing legacy of colonization resulting in systemic racism and intergenerational trauma. Diabetes care includes many aspects of self-care (checking sugar, taking medication, following exercise and diet advice), which is negatively impacted by emotional distress. The emotional distress specific to living with diabetes, known as diabetes distress (DD), is due to feeling overwhelmed by the demands of self-care, fears of complications, and guilt or shame over lifestyle choices. DD is known to be related to decreased wellbeing and poor diabetes control. The rate of DD has not been studied among Indigenous youth, nor have interventions aimed at reducing it to improve diabetes management.
Peer support has been shown to help empower youth and young adults by normalizing their experiences and providing a safe space to express themselves. In the Eeyou Istchee Cree community in Quebec, Jonathan Linton, an Indigenous young adult with diabetes, developed a program for youth with diabetes on management and self-care for diabetes that incorporates traditional elements. As he helps participants be more active and eat healthier, he supports them in their journey with diabetes and creates a safe space for them to voice concerns, easing their distress.
This research study will build on the initiative developed by Mr. Linton to create a community of peer-mentors to provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. To evaluate the program, a combination of questionnaires to assess changes in DD and other emotional factors, measures of diabetes outcomes (glycemia, blood pressure, weight), and Photovoice, a research tool that allows participants to use images to explain their experience with diabetes, will be used.
- Conditions
- Diabetes Mellitus, Distress, Emotional
- Being tested
- Peer mentoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentoringBehavioural
Indigenous young adult peer mentors who will develop and deliver the program based on needs and wants of our participants. The program will be built on their experience and ideas. They will be empowered to guide the program in the direction they see best for their communities.
| Study group | Role | What they receive |
|---|---|---|
| Peer-mentoring | Experimental | Peer-mentoring which will include land based activities, nutrition and physical activity teaching. Receives: Behavioral: Peer mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress
Problem Areas in Diabetes (PAID) scale from 0-100, higher score means more distress
Measured: 0,6 and 12 months
Secondary outcomes (9)
Global Distress
0 item Kessler Psychological Distress scale (K10), from 10-50, the higher the score the greater the global distress.
Measured: 0,6 and 12 months
Resilience-Children
Child and Youth Resilience Measure-Revised (CYRM-R), for 10-18 years old. Scale from 17-85, the higher the score the greater the resilience
Measured: 0,6 and 12 months
Resilience-Adults
Adult Resilience Measure-Revised (ARM-R), for those > 18 years. Scale from 17-85, the higher the score the greater the resilience
Measured: 0,6 and 12 months
Body Mass Index
Weight (kg)/[Height(m)]^2
Measured: 0 and 12 months
Hemoglobin A1c
Percent HbA1c
Measured: 0 and 12 months
urine albumin to creatine ratio
mg/mmol
Measured: 0 and 12 months
low density lipoprotein
mmol/L
Measured: 0 and 12 months
Blood pressure
mmHg
Measured: 0 and 12 months
Lifestyle questionnaire
Developed by Cree Board of health to assess diet and physical activity. Not a scale
Measured: 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Nov 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romina Pace, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Romina Pace, Principal investigator, MUHC-RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430203
- Sponsor's protocol ID
- 2025-10728
- Other IDs
- 2025
- Status last verified
- Oct 2026
- First submitted
- 16 May 2024
- Last updated
- 15 Oct 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indigenous Youth and Young Adults With Diabetes Peer Mentorship Program
- ClinicalTrials.gov ID
- NCT06430203
- Acronym / sponsor ID
- 2025-10728
- Conditions
- Diabetes Mellitus, Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 28 May 2024 (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 goal of this study is to learn if an Indigenous led peer-mentor program can provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. Also, we will learn about Indigenous youth and young adults experience with diabetes.
- Can a peer-mentoring program reduce diabetes distress among Indigenous youth and young adults with diabetes?
- What is it like for Indigenous youth and young adults to be live with diabetes?
- Can a peer-mentoring program reduce global distress and improve resilience among Indigenous youth and young adults with diabetes?
- Can a peer-mentoring program lead to changes in lifestyle (diet, physical activity, substance use) and diabetes related clinical outcomes among Indigenous youth and young adults with diabetes.
Researchers will compare distress, resilience, lifestyles, and diabetes related clinical outcomes before participating in the peer-mentoring program and at 6 and 12 months into the program. Additionally, participants will be asked to share their journey with diabetes through photos throughout the program
Participants will:
- Be paired with peer-mentors who also have diabetes and they will share their journey with diabetes
- Participate in activities (grocery tours, walking clubs, land-based activities, cooking classes) held by peer-mentors
- Complete questionnaires on distress, resilience, and lifestyle every 6 months.
- Participate in Photovoice workshops to share their stories through pictures.
Detailed description
The rates of diabetes are increasing among youth and young adults. This rise is particularly steep among Indigenous peoples who also face high rates of depression and emotional distress due to the ongoing legacy of colonization resulting in systemic racism and intergenerational trauma. Diabetes care includes many aspects of self-care (checking sugar, taking medication, following exercise and diet advice), which is negatively impacted by emotional distress. The emotional distress specific to living with diabetes, known as diabetes distress (DD), is due to feeling overwhelmed by the demands of self-care, fears of complications, and guilt or shame over lifestyle choices. DD is known to be related to decreased wellbeing and poor diabetes control. The rate of DD has not been studied among Indigenous youth, nor have interventions aimed at reducing it to improve diabetes management.
Peer support has been shown to help empower youth and young adults by normalizing their experiences and providing a safe space to express themselves. In the Eeyou Istchee Cree community in Quebec, Jonathan Linton, an Indigenous young adult with diabetes, developed a program for youth with diabetes on management and self-care for diabetes that incorporates traditional elements. As he helps participants be more active and eat healthier, he supports them in their journey with diabetes and creates a safe space for them to voice concerns, easing their distress.
This research study will build on the initiative developed by Mr. Linton to create a community of peer-mentors to provide Indigenous youth and young adults with the support needed to improve their distress and improve their diabetes control. To evaluate the program, a combination of questionnaires to assess changes in DD and other emotional factors, measures of diabetes outcomes (glycemia, blood pressure, weight), and Photovoice, a research tool that allows participants to use images to explain their experience with diabetes, will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer-mentoring | Experimental | Behavioral: Peer mentoringPeer-mentoring which will include land based activities, nutrition and physical activity teaching. |
Who may qualify
- Ages
- 10 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age 10-29 years old Clinical diagnosis of diabetes or gestational diabetes
Key exclusion criteria (1 listed)
- Age > 29 years old Not at risk of diabetes
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 |
|---|---|---|
| Peer mentoringIndigenous young adult peer mentors who will develop and deliver the program based on needs and wants of our participants. The program will be built on their experience and ideas. They will be empowered to guide the program in the direction they see best for their communities. | Behavioural | Peer-mentoring |
Primary outcome
Diabetes Distress
Time frame: 0,6 and 12 months
Problem Areas in Diabetes (PAID) scale from 0-100, higher score means more distress
9 secondary outcomes
Global Distress
Time frame: 0,6 and 12 months
Resilience-Children
Time frame: 0,6 and 12 months
Resilience-Adults
Time frame: 0,6 and 12 months
Body Mass Index
Time frame: 0 and 12 months
Hemoglobin A1c
Time frame: 0 and 12 months
urine albumin to creatine ratio
Time frame: 0 and 12 months
low density lipoprotein
Time frame: 0 and 12 months
Blood pressure
Time frame: 0 and 12 months
Lifestyle questionnaire
Time frame: 0 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Romina Pace principal investigator
MUHC-RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentoring in people with Diabetes Mellitus and Distress, Emotional, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 1 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diabetes Distress (time frame: 0,6 and 12 months). 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 15 Oct 2026.