Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-01-15
Brief Title:
Type 1 Diabetes Exercise and Mentoring Trial
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
TEAM
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 21 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 mentor 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
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 21 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 mentor 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
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