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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Jonathan McGavock, PhD contact

2044801359

jmcgavock@chrim.ca

Jana L Slaght, MSc contact

2047893591

jslaght@chrim.ca

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

Other trials in Canada

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).

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 groups in NCT05724888
Study groupRoleWhat they receive
Intervention_WinnipegExperimentalThe 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_WinnipegNo interventionThe control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association.
Intervention_STPExperimentalThe 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_STPNo interventionThe 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.

  1. 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

  2. Adherence to the intervention arms

    Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.

    Measured: 12 weeks

  3. Retention for follow-up measurements

    Defined as the number of adolescents who complete follow-up measurements at randomization.

    Measured: 24 weeks

Secondary outcomes (3)
  1. 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)

  2. 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)

  3. 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.

  1. First posted13 Feb 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion20 Dec 2023 (estimated)

Resources

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)
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

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.

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