Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05724888
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2022-12-22
Brief Title:
Physical Activity and CVD in Adolescents With Type 2 Diabetes
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Physical Activity and Cardiovascular Disease CVD in Adolescents With Type 2 Diabetes A Pilot Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVD
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 16 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 landnature-based activities by local experts as a pilot to determine appropriateness and feasibility for a larger trial The investigators have previously demonstrated that landoutdoor-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
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 landnature-based activities by local experts as a pilot to determine appropriateness and feasibility for a larger trial The investigators have previously demonstrated that landoutdoor-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None