UnknownNot Applicable

Physical Activity and CVD in Adolescents With Type 2 Diabetes

Canada40 participantsStarted 2023-09-01

Plain-language 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 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.

Who can participate

Age range

14 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 14-17 years old * BMI z score \>1.6 * diagnosed with type 2 diabetes Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Enrollment rates

Timeframe: 12 weeks

Adherence to the intervention arms

Timeframe: 12 weeks

Retention for follow-up measurements

Timeframe: 24 weeks

Trial details

NCT IDNCT05724888

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-20

Contact for this trial

Jonathan McGavock, PhD

2044801359 jmcgavock@chrim.ca

View on ClinicalTrials.gov More Cardiovascular Diseases trials