Type 1 Diabetes, Exercise and Mentoring Trial

NCT06296992 | Recruiting

• 1 other identifier: B2023:035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.

Conditions

Type 1 Diabetes; Physical Activity

Outcome Measures

Primary Outcomes (3)

• Enrollment rates

  Defined as the number of (i) adolescents who consent to participate and are randomized to one of the two study arms during the study period of approximately three years and (ii) the number of young adults who agree and complete the training to become peer mentors to the adolescents during the study period of approximately three years.

  during the study period of approximately three years.

• Adherence to the intervention arms

  Defined as the percentage of prescribed sessions that adolescents attended during the trial period of approximately three years

  during the study period of approximately three years

• Retention for follow-up measurements

  Defined as the percentage of adolescents who complete follow-up measurements during the study period of approximately three years.

  during the study period of approximately three years.

Secondary Outcomes (3)

• Physical activity

  Baseline, week 12, week 24

• Quality of Life (DQOL)

  Baseline, week 12, week 24

• Quality of Life (PedsQL 4.0)

  Baseline, week 12, week 24

Other Outcomes (7)

• Diabetes Distress

  Baseline, week 12, week 24

• Mastery

  Baseline, week 12, week 24

• Autonomy

  Baseline, week 12, week 24

Study Arms (2)

12-week TEAM peer mentor program

EXPERIMENTAL

A 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA.

Behavioral: 12-week TEAM peer mentor program

12-week waitlist control

NO INTERVENTION

A 12-week waitlist control group that receives usual care, including standard educational resources developed by the Canadian Society of Exercise Physiology for adopting and sustaining daily PA. Adolescents randomized to the control arm will be offered the 12 week intervention following the 24 week follow-up time point.

Interventions

12-week TEAM peer mentor program BEHAVIORAL

A 12-week peer-led behavioural intervention that supports increased physical activity. It will consist of 3 weekly contacts between participants and peer mentors that will be a mix of in-person, virtual, and texting. The intervention components and communication between adolescents and peer mentors with T1D will be guided by SDT, and designed to overcome the key psychosocial barriers to PA. The peer mentors that complete the training will deliver a 12-week intervention to increase behavioural skills that foster autonomy for goal setting and overcoming barriers to PA.

12-week TEAM peer mentor program

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• want to increase their daily PA
• currently use a continuous glucose monitor (CGM)

You may not qualify if:

• were diagnosed with T1D within 12 months of randomization
• have diabetes secondary to medications or surgery
• have cancer
• evidence of drug/alcohol abuse
• have an eating disorder
• an orthopedic injury or illness that would limit their ability to engage in daily PA
• a suicide attempt in the previous 12 months
• are pregnant

Sponsors & Collaborators

• University of Manitoba: lead
• Juvenile Diabetes Research Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

the Children's Hospital Research Institute of Manitoba and the University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Trillium Health Partners

Mississauga, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Jonathan McGavock

  University of Manitoba / the Children's Hospital Research Institute of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan McGavock, PhD

CONTACT

204-789-3591; jmcgavock@chrim.ca

Andrea MacIntosh, MSc

CONTACT

204-789-3591; amacintosh@chrim.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: March 6, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)