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Physical Activity Program for Type 2 Diabetes in Adolescents (CVD Trial)
N/A
Waitlist Available
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 12, week 24 (3 weeks total)
Awards & highlights
CVD Trial Summary
This trial will explore if an intervention to increase physical activity can help adolescents with Type 2 Diabetes, and if it can affect their cardiovascular health.
Who is the study for?
This trial is for adolescents aged 14-17 with Type 2 Diabetes who have a BMI z score over 1.6 and don't already do more than 300 minutes of moderate to vigorous physical activity per week. It's not for those on high dose steroids, with cancer, diabetes from surgery or medication for another condition, or substance abuse issues.Check my eligibility
What is being tested?
The study tests if a program combining peer mentorship and increased physical activity can be practical and effective in young people with Type 2 Diabetes. Over the course of 12 weeks, researchers will look at how this approach might improve heart health.See study design
What are the potential side effects?
Since the intervention involves increasing physical activity and peer support without medical or drug treatments, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness.
CVD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 12, week 24 (3 weeks total)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 12, week 24 (3 weeks total)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to the intervention arms
Enrollment rates
Retention for follow-up measurements
Secondary outcome measures
BREQ2 (Behavioral Regulation in Exercise Questionnaire-2) change
Physical activity
Readiness for behavior change
CVD Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Intervention_WinnipegExperimental Treatment1 Intervention
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.
Group II: Intervention_STPExperimental Treatment1 Intervention
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.
Group III: Control_STPActive Control1 Intervention
The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association.
Group IV: Control_WinnipegActive Control1 Intervention
The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association.
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Who is running the clinical trial?
Children's Hospital Research Institute of Manitoba (CHRIM)UNKNOWN
1 Previous Clinical Trials
6 Total Patients Enrolled
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,482 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
122 Previous Clinical Trials
72,066 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking a lot of steroids or medications that reduce your immune system's activity for a long time.Your body mass index (BMI) is higher than it should be for your age and gender.You have been told by a doctor that you have type 2 diabetes.You do more than 300 minutes of moderate to intense exercise each week.You currently have cancer.You have diabetes caused by surgery or medications for another condition.You have a history of using drugs or alcohol in a harmful way.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention_STP
- Group 2: Control_STP
- Group 3: Intervention_Winnipeg
- Group 4: Control_Winnipeg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the criteria for this trial include individuals aged 65 and older?
"This clinical trial permits adolescents between the ages of 14 and 17 to be registered as participants, in accordance with eligibility criteria."
Answered by AI
Is eligibility for participation in this research still available?
"This medical investigation requires potential participants to be of teenage age and have preexisting cardiovascular conditions in order to join. 40 candidates are required for the trial's completion."
Answered by AI
Are volunteers being accepted to participate in this research?
"Per the clinicaltrials.gov website, this trial is not presently accepting applicants. The study was initially posted on September 1st 2023 and updated most recently on February 10th 2023. Although participants are currently not being sought for this particular investigation, 1757 other medical studies have open recruitment at present."
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