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Physical Activity and CVD in Adolescents With Type 2 Diabetes (CVD)

Primary Purpose

Cardiovascular Diseases, Type2diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Peer mentorship and physical activity
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring resilience, peer mentorship

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Manitoba / Children's Hospital Research Institute of Manitoba (CHRIM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Intervention_Winnipeg

Control_Winnipeg

Intervention_STP

Control_STP

Arm Description

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.

The control group 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.

The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association.

Outcomes

Primary Outcome Measures

Enrollment rates
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
Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.
Retention for follow-up measurements
Defined as the number of adolescents who complete follow-up measurements at randomization.

Secondary Outcome Measures

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.
Readiness for behavior change
This will be assessed using the PACE readiness questionnaire, which assesses readiness for, physical activity goals and screen time.
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.

Full Information

First Posted
December 22, 2022
Last Updated
March 13, 2023
Sponsor
University of Manitoba
Collaborators
Heart and Stroke Foundation of Canada, Children's Hospital Research Institute of Manitoba (CHRIM)
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1. Study Identification

Unique Protocol Identification Number
NCT05724888
Brief Title
Physical Activity and CVD in Adolescents With Type 2 Diabetes
Acronym
CVD
Official Title
Physical Activity and Cardiovascular Disease (CVD) in Adolescents With Type 2 Diabetes: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Heart and Stroke Foundation of Canada, Children's Hospital Research Institute of Manitoba (CHRIM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Type2diabetes
Keywords
resilience, peer mentorship

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention_Winnipeg
Arm Type
Experimental
Arm Description
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.
Arm Title
Control_Winnipeg
Arm Type
No Intervention
Arm Description
The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association.
Arm Title
Intervention_STP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control_STP
Arm Type
No Intervention
Arm Description
The control group will receive standard recommendations for increasing daily PA from the Canadian Society of Exercise Physiology and the American Heart Association.
Intervention Type
Behavioral
Intervention Name(s)
Peer mentorship and physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment rates
Description
Defined as the number of adolescents who consent to participate and are randomized to one of the two study arms.
Time Frame
12 weeks
Title
Adherence to the intervention arms
Description
Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.
Time Frame
12 weeks
Title
Retention for follow-up measurements
Description
Defined as the number of adolescents who complete follow-up measurements at randomization.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
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.
Time Frame
week 1, week 12, week 24 (3 weeks total)
Title
Readiness for behavior change
Description
This will be assessed using the PACE readiness questionnaire, which assesses readiness for, physical activity goals and screen time.
Time Frame
week 1, week 12, week 24 (measures will be taken at 3 different time points)
Title
BREQ2 (Behavioral Regulation in Exercise Questionnaire-2) change
Description
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.
Time Frame
week 1, week 12, week 24 (measures will be taken at 3 different time points)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan McGavock, PhD
Phone
2044801359
Email
jmcgavock@chrim.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jana L Slaght, MSc
Phone
2047893591
Email
jslaght@chrim.ca
Facility Information:
Facility Name
University of Manitoba / Children's Hospital Research Institute of Manitoba (CHRIM)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E3P4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan McGavock, PhD
Phone
2044801359
Email
jmcgavock@chrim.ca
First Name & Middle Initial & Last Name & Degree
Jana L Slaght, MSc
Phone
20499816637893591
Email
jslaght@chrim.ca
First Name & Middle Initial & Last Name & Degree
Jonathan McGavock, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Activity and CVD in Adolescents With Type 2 Diabetes

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