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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Enrollment rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •want to increase their daily PA
- •currently use a continuous glucose monitor (CGM)
排除标准
- •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
研究组 & 干预措施
12-week TEAM peer mentor program
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.
干预措施: 12-week TEAM peer mentor program (Behavioral)
12-week waitlist control
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.
结局指标
主要结局
Enrollment rates
时间窗: during the study period of approximately three years.
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.
Adherence to the intervention arms
时间窗: during the study period of approximately three years
Defined as the percentage of prescribed sessions that adolescents attended during the trial period of approximately three years
Retention for follow-up measurements
时间窗: during the study period of approximately three years.
Defined as the percentage of adolescents who complete follow-up measurements during the study period of approximately three years.
次要结局
- 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)
研究者
Jon McGavock
Professor
University of Manitoba