Physical Activity and CVD in Adolescents With Type 2 Diabetes

Cardiovascular Diseases Clinical Trial

— CVD  

Official title:

Physical Activity and Cardiovascular Disease (CVD) in Adolescents With Type 2 Diabetes: A Pilot Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724888
• Other study ID #: HS25697(B2022:099)
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2023
• Source: University of Manitoba
• Contact: Jonathan McGavock, PhD
• Phone: 2044801359
• Email: jmcgavock[@]chrim.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Peer mentorship and physical activity
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.

Locations

Country	Name	City	State
Canada	University of Manitoba / Children's Hospital Research Institute of Manitoba (CHRIM)	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Children's Hospital Research Institute of Manitoba (CHRIM), Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rates	Defined as the number of adolescents who consent to participate and are randomized to one of the two study arms.	12 weeks
Primary	Adherence to the intervention arms	Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.	12 weeks
Primary	Retention for follow-up measurements	Defined as the number of adolescents who complete follow-up measurements at randomization.	24 weeks
Secondary	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.	week 1, week 12, week 24 (3 weeks total)
Secondary	Readiness for behavior change	This will be assessed using the PACE readiness questionnaire, which assesses readiness for, physical activity goals and screen time.	week 1, week 12, week 24 (measures will be taken at 3 different time points)
Secondary	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.	week 1, week 12, week 24 (measures will be taken at 3 different time points)