Clinical trial NCT06296992: Type 1 Diabetes, Exercise and Mentoring Trial
Official title: Type 1 Diabetes, Exercise and Mentoring (TEAM) Trial: a Randomized Controlled Pilot Trial Using Peer Mentorship to Increase Physical Activity and Quality of Life in Adolescents with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Physical Activity
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Rationale: Empowering adolescents with type 1 diabetes (T1D) to increase daily physical activity (a cornerstone behaviour in diabetes self-management) is well-defined knowledge gap in pediatric endocrinology clinical practice. Adopting a lifestyle that includes regular physical activity (PA) is essential for the optimal health and quality of life (QoL) of adolescents living with T1D, however Diabetes Canada clinical practice guidelines provide no evidence for optimal behavioural approaches for achieving the extensive self-management behaviours needed to prevent diabetes-related complications during a critical stage of psychological, social and emotional development. As such, daily PA levels remain low in adolescents with T1D and many do not meet current recommendations for daily PA. The aim of this pilot trial is to assess the feasibility, preliminary efficacy and safety of a novel peer-led behavioural intervention to increase PA and quality of life for adolescents living with T1D.

Methodology: Investigators will conduct a pilot randomized controlled trial comparing a peer-led, behavioural intervention, to standard of care on daily PA and quality of life. Investigators will also conduct a qualitative study within the trial to understand the contextual factors that influenced the peer mentoring approach to empowering adolescents with T1D.

Population: Sixty adolescents 13-17 years of age living with T1D from 2 sites in Canada who will be randomized 2:1 to intervention or control arms, respectively.

Intervention Arm: A 12-week behavioural intervention guided by the tenets of self-determination theory, and led by a physically active young adult mentors, 21-30 yrs of age living with T1D. Mentors will rely on motivational interviewing skills to support adolescents living with T1D to increase daily PA by fostering a sense of autonomy for goal setting and self-management skill acquisition, competency in their ability to increase daily PA without compromising glucose management and a sense of relatedness to a community of adolescents overcoming similar challenges.

Control Arm: Adolescents in the wait-list control arm will receive standard clinical recommendations to increase daily PA.

Investigators will also conduct a qualitative study with 10 adolescents who participated in the intervention. The qualitative component will attempt to (1) identify the complex factors that influenced adherence to the intervention; (2) determine the appropriateness and relevance of peer mentoring for adolescents with T1D; (3) explore sex, gender and psychosocial-specific factors related to the delivery of the peer mentoring intervention; and (4) explore possible novel mediators of the effect of the study arms on psychosocial health, quality of life and health behaviours.

Timing: Feasibility and fidelity outcomes will be assessed throughout the trial and at the 12-week time point.

Patient-engagement: Patient co-researchers from Canada and Ireland participated in several formative studies that informed this proposal. They co-designed the novel peer-led intervention and all aspects of the trial outlined in this proposal.

Importance: The results of this trial will inform a larger trial to provide much needed empirical evidence for inform pediatric diabetes clinical practice guidelines for behavioural strategies to improve self management and quality of life for adolescents living with T1D.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Enrollment rates
timeFrame: during the study period of approximately three years.
measure: Adherence to the intervention arms
timeFrame: during the study period of approximately three years
measure: Retention for follow-up measurements
timeFrame: during the study period of approximately three years.
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, week 12, week 24
measure: Quality of Life (DQOL)
timeFrame: Baseline, week 12, week 24
measure: Quality of Life (PedsQL 4.0)
timeFrame: Baseline, week 12, week 24
Other outcomes:
measure: Diabetes Distress
timeFrame: Baseline, week 12, week 24
measure: Mastery
timeFrame: Baseline, week 12, week 24
measure: Autonomy
timeFrame: Baseline, week 12, week 24
measure: Motivation for physical activity (LCE)
timeFrame: Baseline, week 12, week 24
measure: Readiness for change
timeFrame: Baseline, week 12, week 24
measure: Motivation to engage in exercise
timeFrame: Baseline, week 12, week 24
measure: Motivation for Physical Activity (EMI-2)
timeFrame: Baseline, week 12, week 24
Locations:
city: Winnipeg
country: Canada
facility: the Children's Hospital Research Institute of Manitoba and the University of Manitoba
state: Manitoba
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
Study officials:
affiliation: University of Manitoba / the Children's Hospital Research Institute of Manitoba
name: Jonathan McGavock
role: PRINCIPAL_INVESTIGATOR
References: