Type 1 DiabetesTEAMNCT06296992
Type 1 Diabetes, Exercise and Mentoring Trial
A study testing 12-week TEAM peer mentor program in people with Type 1 Diabetes and Physical Activity, run by University of Manitoba at 2 sites in Canada.
Trial summary
The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes, Physical Activity
- What is being tested?
- 12-week TEAM peer mentor program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2025to May 2027
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- want to increase their daily PA
- currently use a continuous glucose monitor (CGM)
Who cannot join
- were diagnosed with T1D within 12 months of randomization
- have diabetes secondary to medications or surgery
- have cancer
- evidence of drug/alcohol abuse
- have an eating disorder
- an orthopedic injury or illness that would limit their ability to engage in daily PA
- a suicide attempt in the previous 12 months
- are pregnant
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Trillium Health Partners
Mississauga, Ontario
Ian Zenlea, 905-848-7580 ext. 2203, ian.zenlea@thp.ca
- Recruiting
the Children's Hospital Research Institute of Manitoba and the University of Manitoba
Winnipeg, Manitoba
Jonathan McGavock, 204-789-3591, jmcgavock@chrim.ca
About this study
Official title: Type 1 Diabetes, Exercise and Mentoring (TEAM) Trial: A Randomized Controlled Pilot Trial Using Peer Mentorship to Increase Physical Activity and Quality of Life in Adolescents With Type 1 Diabetes
The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.
Read the detailed description
Rationale: Empowering adolescents with type 1 diabetes (T1D) to increase daily physical activity (a cornerstone behaviour in diabetes self-management) is well-defined knowledge gap in pediatric endocrinology clinical practice. Adopting a lifestyle that includes regular physical activity (PA) is essential for the optimal health and quality of life (QoL) of adolescents living with T1D, however Diabetes Canada clinical practice guidelines provide no evidence for optimal behavioural approaches for achieving the extensive self-management behaviours needed to prevent diabetes-related complications during a critical stage of psychological, social and emotional development. As such, daily PA levels remain low in adolescents with T1D and many do not meet current recommendations for daily PA. The aim of this pilot trial is to assess the feasibility, preliminary efficacy and safety of a novel peer-led behavioural intervention to increase PA and quality of life for adolescents living with T1D.
Methodology: Investigators will conduct a pilot randomized controlled trial comparing a peer-led, behavioural intervention, to standard of care on daily PA and quality of life. Investigators will also conduct a qualitative study within the trial to understand the contextual factors that influenced the peer mentoring approach to empowering adolescents with T1D.
Population: Sixty adolescents 13-17 years of age living with T1D from 2 sites in Canada who will be randomized 2:1 to intervention or control arms, respectively.
Intervention Arm: A 12-week behavioural intervention guided by the tenets of self-determination theory, and led by a physically active young adult mentors, 21-30 yrs of age living with T1D. Mentors will rely on motivational interviewing skills to support adolescents living with T1D to increase daily PA by fostering a sense of autonomy for goal setting and self-management skill acquisition, competency in their ability to increase daily PA without compromising glucose management and a sense of relatedness to a community of adolescents overcoming similar challenges.
Control Arm: Adolescents in the wait-list control arm will receive standard clinical recommendations to increase daily PA.
Investigators will also conduct a qualitative study with 10 adolescents who participated in the intervention. The qualitative component will attempt to (1) identify the complex factors that influenced adherence to the intervention; (2) determine the appropriateness and relevance of peer mentoring for adolescents with T1D; (3) explore sex, gender and psychosocial-specific factors related to the delivery of the peer mentoring intervention; and (4) explore possible novel mediators of the effect of the study arms on psychosocial health, quality of life and health behaviours.
Timing: Feasibility and fidelity outcomes will be assessed throughout the trial and at the 12-week time point.
Patient-engagement: Patient co-researchers from Canada and Ireland participated in several formative studies that informed this proposal. They co-designed the novel peer-led intervention and all aspects of the trial outlined in this proposal.
Importance: The results of this trial will inform a larger trial to provide much needed empirical evidence for inform pediatric diabetes clinical practice guidelines for behavioural strategies to improve self management and quality of life for adolescents living with T1D.
- Conditions
- Type 1 Diabetes, Physical Activity
- Being tested
- 12-week TEAM peer mentor program
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week TEAM peer mentor programBehavioural
A 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA.
| Study group | Role | What they receive |
|---|---|---|
| 12-week TEAM peer mentor program | Experimental | A 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA. Receives: Behavioral: 12-week TEAM peer mentor program |
| 12-week waitlist control | No intervention | A 12-week waitlist control group that receives usual care, including standard educational resources developed by the Canadian Society of Exercise Physiology for adopting and sustaining daily PA. Adolescents randomized to the control arm will be offered the 12 week intervention following the 24 week follow-up time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rates
Defined as the number of (i) adolescents who consent to participate and are randomized to one of the two study arms during the study period of approximately three years and (ii) the number of young adults who agree and complete the training to become peer mentors to the adolescents during the study period of approximately three years.
Measured: during the study period of approximately three years.
Adherence to the intervention arms
Defined as the percentage of prescribed sessions that adolescents attended during the trial period of approximately three years
Measured: during the study period of approximately three years
Retention for follow-up measurements
Defined as the percentage of adolescents who complete follow-up measurements during the study period of approximately three years.
Measured: during the study period of approximately three years.
Secondary outcomes (3)
Physical activity
Daily moderate to vigorous physical activity measured for seven days with a waist mounted accelerometer
Measured: Baseline, week 12, week 24
Quality of Life (DQOL)
The Health-Related Quality of Life in persons living with diabetes (DQOL) will be used to measure overall quality of life. Lower scores indicate better quality of life.
Measured: Baseline, week 12, week 24
Quality of Life (PedsQL 4.0)
Quality of Life (PedsQL 4.0) will be used to measure the condition-specific quality of life. Lower scores indicate better quality of life.
Measured: Baseline, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Feb 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
- Investigators
- Jonathan McGavock, Principal investigator, University of Manitoba / the Children's Hospital Research Institute of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296992
- Sponsor's protocol ID
- B2023:035
- Acronym
- TEAM
- Status last verified
- May 2026
- First submitted
- 15 Jan 2024
- 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
- Type 1 Diabetes, Exercise and Mentoring (TEAM) Trial: A Randomized Controlled Pilot Trial Using Peer Mentorship to Increase Physical Activity and Quality of Life in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06296992
- Acronym / sponsor ID
- TEAM / B2023:035
- Conditions
- Type 1 Diabetes, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Mar 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 proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.
Detailed description
Rationale: Empowering adolescents with type 1 diabetes (T1D) to increase daily physical activity (a cornerstone behaviour in diabetes self-management) is well-defined knowledge gap in pediatric endocrinology clinical practice. Adopting a lifestyle that includes regular physical activity (PA) is essential for the optimal health and quality of life (QoL) of adolescents living with T1D, however Diabetes Canada clinical practice guidelines provide no evidence for optimal behavioural approaches for achieving the extensive self-management behaviours needed to prevent diabetes-related complications during a critical stage of psychological, social and emotional development. As such, daily PA levels remain low in adolescents with T1D and many do not meet current recommendations for daily PA. The aim of this pilot trial is to assess the feasibility, preliminary efficacy and safety of a novel peer-led behavioural intervention to increase PA and quality of life for adolescents living with T1D.
Methodology: Investigators will conduct a pilot randomized controlled trial comparing a peer-led, behavioural intervention, to standard of care on daily PA and quality of life. Investigators will also conduct a qualitative study within the trial to understand the contextual factors that influenced the peer mentoring approach to empowering adolescents with T1D.
Population: Sixty adolescents 13-17 years of age living with T1D from 2 sites in Canada who will be randomized 2:1 to intervention or control arms, respectively.
Intervention Arm: A 12-week behavioural intervention guided by the tenets of self-determination theory, and led by a physically active young adult mentors, 21-30 yrs of age living with T1D. Mentors will rely on motivational interviewing skills to support adolescents living with T1D to increase daily PA by fostering a sense of autonomy for goal setting and self-management skill acquisition, competency in their ability to increase daily PA without compromising glucose management and a sense of relatedness to a community of adolescents overcoming similar challenges.
Control Arm: Adolescents in the wait-list control arm will receive standard clinical recommendations to increase daily PA.
Investigators will also conduct a qualitative study with 10 adolescents who participated in the intervention. The qualitative component will attempt to (1) identify the complex factors that influenced adherence to the intervention; (2) determine the appropriateness and relevance of peer mentoring for adolescents with T1D; (3) explore sex, gender and psychosocial-specific factors related to the delivery of the peer mentoring intervention; and (4) explore possible novel mediators of the effect of the study arms on psychosocial health, quality of life and health behaviours.
Timing: Feasibility and fidelity outcomes will be assessed throughout the trial and at the 12-week time point.
Patient-engagement: Patient co-researchers from Canada and Ireland participated in several formative studies that informed this proposal. They co-designed the novel peer-led intervention and all aspects of the trial outlined in this proposal.
Importance: The results of this trial will inform a larger trial to provide much needed empirical evidence for inform pediatric diabetes clinical practice guidelines for behavioural strategies to improve self management and quality of life for adolescents living with T1D.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week TEAM peer mentor program | Experimental | Behavioral: 12-week TEAM peer mentor programA 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA. |
| 12-week waitlist control | No intervention | –A 12-week waitlist control group that receives usual care, including standard educational resources developed by the Canadian Society of Exercise Physiology for adopting and sustaining daily PA. Adolescents randomized to the control arm will be offered the 12 week intervention following the 24 week follow-up time point. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- want to increase their daily PA
- currently use a continuous glucose monitor (CGM)
Key exclusion criteria (8 listed)
- were diagnosed with T1D within 12 months of randomization
- have diabetes secondary to medications or surgery
- have cancer
- evidence of drug/alcohol abuse
- have an eating disorder
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 |
|---|---|---|
| 12-week TEAM peer mentor programA 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA. | Behavioural | 12-week TEAM peer mentor program |
Primary outcome
Enrollment rates
Time frame: during the study period of approximately three years.
Defined as the number of (i) adolescents who consent to participate and are randomized to one of the two study arms during the study period of approximately three years and (ii) the number of young adults who agree and complete the training to become peer mentors to the adolescents during the study period of approximately three years.
Adherence to the intervention arms
Time frame: during the study period of approximately three years
Defined as the percentage of prescribed sessions that adolescents attended during the trial period of approximately three years
Retention for follow-up measurements
Time frame: during the study period of approximately three years.
Defined as the percentage of adolescents who complete follow-up measurements during the study period of approximately three years.
3 secondary outcomes
Physical activity
Time frame: Baseline, week 12, week 24
Quality of Life (DQOL)
Time frame: Baseline, week 12, week 24
Quality of Life (PedsQL 4.0)
Time frame: Baseline, week 12, week 24
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 1 Jun 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.
Jonathan McGavock principal investigator
University of Manitoba / the Children's Hospital Research Institute of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week TEAM peer mentor program in people with Type 1 Diabetes and Physical Activity, run by University of Manitoba at 2 sites 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 2 inclusion and 8 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: looking for participants now, 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 2 sites 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?
Contact Jonathan McGavock, PhD (204-789-3591, jmcgavock@chrim.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rates (time frame: during the study period of approximately three years.). 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.