Cardiovascular DiseasesCVDNCT05724888
Physical Activity and CVD in Adolescents With Type 2 Diabetes
A study testing Peer mentorship and physical activity in people with Cardiovascular Diseases and Type2diabetes, run by University of Manitoba at 1 site in Canada.
Trial summary
The main research questions for this study are: (1) Is delivering a resiliency-informed behavioural intervention designed to increase physical activity (PA) feasible for adolescents living with Type 2 Diabetes (T2D)? and (2) What is the expected change in proposed cardiovascular outcomes after 12 weeks in both study… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Type2diabetes
- What is being tested?
- Peer mentorship and physical activity
- 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 Sep 2023to 20 Dec 2023
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 14-17 years old
- BMI z score >1.6
- diagnosed with type 2 diabetes
Who cannot join
- engage in >300 minutes of moderate-vigorous physical activity per week
- have diabetes because of surgery or medications for another condition
- use chronic high dose steroids or immunosuppressive therapy
- they have cancer
- the have evidence of drug or alcohol abuse
- if youth and/or parent/guardian are unable or unwilling to give consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba / Children's Hospital Research Institute of Manitoba (CHRIM)
Winnipeg, Manitoba, R3E3P4
Jonathan McGavock, PhD, 2044801359, jmcgavock@chrim.ca
Jana L Slaght, MSc, 20499816637893591, jslaght@chrim.ca
About this study
Official title: Physical Activity and Cardiovascular Disease (CVD) in Adolescents With Type 2 Diabetes: A Pilot Randomized Trial
The main research questions for this study are: (1) Is delivering a resiliency-informed behavioural intervention designed to increase physical activity (PA) feasible for adolescents living with Type 2 Diabetes (T2D)? and (2) What is the expected change in proposed cardiovascular outcomes after 12 weeks in both study arms? Qualitative and quantitative methods embedded in this pilot randomized trial will answer these questions and determine the feasibility of a larger randomized controlled trial.
Read the detailed description
Forty adolescents with T2D, 14-17 years old with a body mass index (BMI) Z score > 1.6 and do not engage in regular PA (< 300 mins of moderate to vigorous PA weekly) will be recruited from the iCARE cohort study and the pediatric T2D clinic in Winnipeg. A research assistant will recruit participants from the pediatric endocrinology clinic (DER-CA), and the Manitoba-based iCARE cohort who have previously given consent to be approached for other studies. Participants will be screened by a pediatric endocrinologist to ensure they meet inclusion criteria prior to being approached to participate. Adolescents that are eligible with be consented by the research assistant, then randomized to study arms using a computer-generated program developed by a statistician not affiliated with the study.
The control arm will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association. The intervention arm will take place in a 12 week intervention (3 sessions per week) which will use a peer mentoring network based on the circle of courage to encourage adolescents with T2D to achieve the WHO recommended target of 300 minutes of moderate to vigorous PA weekly.
Session #1: Will be a group-based activity session, where adolescents will meet in person or join virtually to complete 20-30 minutes of reflecting on the past week and goal setting for upcoming week with an additional 30 to 40 minutes of PA led by a kinesiologist and peer mentor. Session #2: Will be a 15-minute wellness check, to determine emotional, mental, physical and social well-being with a peer mentor. The adolescent with T2D will also reflect on the goals set for the week and complete a structured 30-minute activity session. Session #3: Will be a 30-minute session by the adolescent on a weekend day. Prior to the session the adolescent will receive a text or social media prompts from the kinesiologist or peer mentor.
All weekly sessions throughout the 12-week intervention will incorporate the four core tenets of the Circle of CourageTM and three tenets of Self Determination Theory. During Phase 1 (Weeks 1-3) of the intervention, the focus will be on creating a sense of Belonging and relatedness. Group sessions will focus on sharing past experiences with behaviour change, unique challenges of living with T2D and shared interests or passions that will connect adolescents to each other and the intervention. During Phase 2 (Weeks 4-6), the intervention will focus on the concepts of Mastery and competence. The kinesiologist and peer mentor will encourage adolescents to focus on strengths in their lives. Reflecting on the previous four weeks and their adolescence, what behaviours or support have helped them adopt a more active lifestyle. Adolescents will also be taught land/nature-based activities by local experts as a pilot to determine appropriateness and feasibility for a larger trial. The investigators have previously demonstrated that land/outdoor-based activities are associated with significantly higher PA among adolescents. During Phase 3 (Weeks 7-9), the kinesiologist and peer mentor will foster a sense of Independence and autonomy. Adolescents will set goals, begin the process of journaling their experiences and factors that influence their motivation and actions towards adopting a more active lifestyle. During Phase 4 (weeks 10-12) the group will incorporate Generosity into their activity goals. The group will identify opportunities to be active in their communities while also giving back in some way (volunteering for Meals on Wheels, park maintenance, organize activities for children).
- Conditions
- Cardiovascular Diseases, Type2diabetes
- Being tested
- Peer mentorship and physical activity
- Keywords
- resilience, peer mentorship
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentorship and physical activityBehavioural
Participants will be asked to participate for 12 weeks, attending 3 sessions per week (if in the intervention arm). Session 1 will be a group session that will be about 90 minutes, session 2 will be an individual session with a peer mentor for 20-30 minutes, and session 3 will be a virtual check in with the peer mentor about 15 minutes. The intervention will focus on increasing physical activity through the circle of courage.
| Study group | Role | What they receive |
|---|---|---|
| Intervention_Winnipeg | Experimental | The intervention arm will take place in a 12 week intervention (3 sessions per week) which will use a peer mentoring network based on the circle of courage to encourage adolescents with T2D to achieve the WHO recommended target of 300 minutes of moderate to vigorous PA weekly. Receives: Behavioral: Peer mentorship and physical activity |
| Control_Winnipeg | No intervention | The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association. |
| Intervention_STP | Experimental | The intervention arm will take place in a 12 week intervention (3 sessions per week) which will use a peer mentoring network based on the circle of courage to encourage adolescents with T2D to achieve the WHO recommended target of 300 minutes of moderate to vigorous PA weekly. Receives: Behavioral: Peer mentorship and physical activity |
| Control_STP | No intervention | The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rates
Defined as the number of adolescents who consent to participate and are randomized to one of the two study arms.
Measured: 12 weeks
Adherence to the intervention arms
Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.
Measured: 12 weeks
Retention for follow-up measurements
Defined as the number of adolescents who complete follow-up measurements at randomization.
Measured: 24 weeks
Secondary outcomes (3)
Physical activity
Daily moderate to vigorous PA, will be assessed using 7-day waist mounted accelerometery (Actigraph). Adolescents will be asked to wear the accelerometers for 12 hours/day, seven days/week.
Measured: week 1, week 12, week 24 (3 weeks total)
Readiness for behavior change
This will be assessed using the PACE readiness questionnaire, which assesses readiness for, physical activity goals and screen time.
Measured: week 1, week 12, week 24 (measures will be taken at 3 different time points)
BREQ2 (Behavioral Regulation in Exercise Questionnaire-2) change
the BREQ2 (Behavioral Regulation in Exercise Questionnaire-2), which is a measure of the level of motivation to engage in exercise from a self-determination perspective.
Measured: week 1, week 12, week 24 (measures will be taken at 3 different time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Sep 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Model description
- Participants will be from 2 different locations. 1) Winnipeg, MB, Canada 2) St. Theresa Point First Nations, MB, Canada. 20 participants will be recruited from each location and then at each location participants will be randomized in a 1:1 fashion to one of two arms for 12 weeks: (A) A behavioural lifestyle intervention that supports increased PA or (B) a control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Children's Hospital Research Institute of Manitoba
- Responsible party
- Principal investigator, Jon McGavock, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724888
- Sponsor's protocol ID
- HS25697(B2022:099)
- Acronym
- CVD
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2022
- Last updated
- 16 Mar 2023
- 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Cardiovascular Disease (CVD) in Adolescents With Type 2 Diabetes: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05724888
- Acronym / sponsor ID
- CVD / HS25697(B2022:099)
- Conditions
- Cardiovascular Diseases, Type2diabetes
- Keywords
- resilience, peer mentorship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Children's Hospital Research Institute of Manitoba
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 13 Feb 2023 (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 main research questions for this study are: (1) Is delivering a resiliency-informed behavioural intervention designed to increase physical activity (PA) feasible for adolescents living with Type 2 Diabetes (T2D)? and (2) What is the expected change in proposed cardiovascular outcomes after 12 weeks in both study arms? Qualitative and quantitative methods embedded in this pilot randomized trial will answer these questions and determine the feasibility of a larger randomized controlled trial.
Detailed description
Forty adolescents with T2D, 14-17 years old with a body mass index (BMI) Z score > 1.6 and do not engage in regular PA (< 300 mins of moderate to vigorous PA weekly) will be recruited from the iCARE cohort study and the pediatric T2D clinic in Winnipeg. A research assistant will recruit participants from the pediatric endocrinology clinic (DER-CA), and the Manitoba-based iCARE cohort who have previously given consent to be approached for other studies. Participants will be screened by a pediatric endocrinologist to ensure they meet inclusion criteria prior to being approached to participate. Adolescents that are eligible with be consented by the research assistant, then randomized to study arms using a computer-generated program developed by a statistician not affiliated with the study.
The control arm will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association. The intervention arm will take place in a 12 week intervention (3 sessions per week) which will use a peer mentoring network based on the circle of courage to encourage adolescents with T2D to achieve the WHO recommended target of 300 minutes of moderate to vigorous PA weekly.
Session #1: Will be a group-based activity session, where adolescents will meet in person or join virtually to complete 20-30 minutes of reflecting on the past week and goal setting for upcoming week with an additional 30 to 40 minutes of PA led by a kinesiologist and peer mentor. Session #2: Will be a 15-minute wellness check, to determine emotional, mental, physical and social well-being with a peer mentor. The adolescent with T2D will also reflect on the goals set for the week and complete a structured 30-minute activity session. Session #3: Will be a 30-minute session by the adolescent on a weekend day. Prior to the session the adolescent will receive a text or social media prompts from the kinesiologist or peer mentor.
All weekly sessions throughout the 12-week intervention will incorporate the four core tenets of the Circle of CourageTM and three tenets of Self Determination Theory. During Phase 1 (Weeks 1-3) of the intervention, the focus will be on creating a sense of Belonging and relatedness. Group sessions will focus on sharing past experiences with behaviour change, unique challenges of living with T2D and shared interests or passions that will connect adolescents to each other and the intervention. During Phase 2 (Weeks 4-6), the intervention will focus on the concepts of Mastery and competence. The kinesiologist and peer mentor will encourage adolescents to focus on strengths in their lives. Reflecting on the previous four weeks and their adolescence, what behaviours or support have helped them adopt a more active lifestyle. Adolescents will also be taught land/nature-based activities by local experts as a pilot to determine appropriateness and feasibility for a larger trial. The investigators have previously demonstrated that land/outdoor-based activities are associated with significantly higher PA among adolescents. During Phase 3 (Weeks 7-9), the kinesiologist and peer mentor will foster a sense of Independence and autonomy. Adolescents will set goals, begin the process of journaling their experiences and factors that influence their motivation and actions towards adopting a more active lifestyle. During Phase 4 (weeks 10-12) the group will incorporate Generosity into their activity goals. The group will identify opportunities to be active in their communities while also giving back in some way (volunteering for Meals on Wheels, park maintenance, organize activities for children).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be from 2 different locations. 1) Winnipeg, MB, Canada 2) St. Theresa Point First Nations, MB, Canada. 20 participants will be recruited from each location and then at each location participants will be randomized in a 1:1 fashion to one of two arms for 12 weeks: (A) A behavioural lifestyle intervention that supports increased PA or (B) a control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention_Winnipeg | Experimental | Behavioral: Peer mentorship and physical activityThe intervention arm will take place in a 12 week intervention (3 sessions per week) which will use a peer mentoring network based on the circle of courage to encourage adolescents with T2D to achieve the WHO recommended target of 300 minutes of moderate to vigorous PA weekly. |
| Control_Winnipeg | No intervention | –The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association. |
| Intervention_STP | Experimental | Behavioral: Peer mentorship and physical activityThe intervention arm will take place in a 12 week intervention (3 sessions per week) which will use a peer mentoring network based on the circle of courage to encourage adolescents with T2D to achieve the WHO recommended target of 300 minutes of moderate to vigorous PA weekly. |
| Control_STP | No intervention | –The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 14-17 years old
- BMI z score >1.6
- diagnosed with type 2 diabetes
Key exclusion criteria (6 listed)
- engage in >300 minutes of moderate-vigorous physical activity per week
- have diabetes because of surgery or medications for another condition
- use chronic high dose steroids or immunosuppressive therapy
- they have cancer
- the have evidence of drug or alcohol abuse
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 mentorship and physical activityParticipants will be asked to participate for 12 weeks, attending 3 sessions per week (if in the intervention arm). Session 1 will be a group session that will be about 90 minutes, session 2 will be an individual session with a peer mentor for 20-30 minutes, and session 3 will be a virtual check in with the peer mentor about 15 minutes. The intervention will focus on increasing physical activity through the circle of courage. | Behavioural | Intervention_STP, Intervention_Winnipeg |
Primary outcome
Enrollment rates
Time frame: 12 weeks
Defined as the number of adolescents who consent to participate and are randomized to one of the two study arms.
Adherence to the intervention arms
Time frame: 12 weeks
Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.
Retention for follow-up measurements
Time frame: 24 weeks
Defined as the number of adolescents who complete follow-up measurements at randomization.
3 secondary outcomes
Physical activity
Time frame: week 1, week 12, week 24 (3 weeks total)
Readiness for behavior change
Time frame: week 1, week 12, week 24 (measures will be taken at 3 different time points)
BREQ2 (Behavioral Regulation in Exercise Questionnaire-2) change
Time frame: week 1, week 12, week 24 (measures will be taken at 3 different time points)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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. This study is not recruiting at the moment.
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 mentorship and physical activity in people with Cardiovascular Diseases and Type2diabetes, run by University of Manitoba 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan McGavock, PhD (2044801359, 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: 12 weeks). 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 16 Mar 2023.