Physical Activity and CVD in Adolescents With Type 2 Diabetes

NCT05724888 | Unknown

• 1 other identifier: HS25697(B2022:099)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Type2diabetes

Keywords

resilience; peer mentorship

Outcome Measures

Primary Outcomes (3)

• Enrollment rates

  Defined as the number of adolescents who consent to participate and are randomized to one of the two study arms.

  12 weeks

• Adherence to the intervention arms

  Defined as the percentage of prescribed sessions that adolescents/families attended during the trial.

  12 weeks

• Retention for follow-up measurements

  Defined as the number of adolescents who complete follow-up measurements at randomization.

  24 weeks

Secondary Outcomes (3)

• Physical activity

  week 1, week 12, week 24 (3 weeks total)

• Readiness for behavior change

  week 1, week 12, week 24 (measures will be taken at 3 different time points)

• BREQ2 (Behavioral Regulation in Exercise Questionnaire-2) change

  week 1, week 12, week 24 (measures will be taken at 3 different time points)

Study Arms (4)

Intervention_Winnipeg

EXPERIMENTAL

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.

Behavioral: Peer mentorship and physical activity

Control_Winnipeg

NO INTERVENTION

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

Intervention_STP

EXPERIMENTAL

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.

Behavioral: Peer mentorship and physical activity

Control_STP

NO INTERVENTION

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

Interventions

Peer mentorship and physical activity BEHAVIORAL

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.

Intervention_STP; Intervention_Winnipeg

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• BMI z score \>1.6
• diagnosed with type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Heart and Stroke Foundation of Canada: collaborator
• Children's Hospital Research Institute of Manitoba (CHRIM): collaborator

Study Sites (1)

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

Winnipeg, Manitoba, R3E3P4, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jonathan McGavock, PhD

CONTACT

2044801359; jmcgavock@chrim.ca

Jana L Slaght, MSc

CONTACT

2047893591; jslaght@chrim.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 13, 2023
• Study Start: September 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)