Type 1 Diabetes, Exercise and Mentoring Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
want to increase their daily PA
currently use a continuous glucose monitor (CGM)
Disqualifiers
were diagnosed with T1D within 12 months of randomization
have diabetes secondary to medications or surgery
have cancer
evidence of drug/alcohol abuse
Trial design
Design model
Parallel
Treatments tested in this trial
12-week TEAM peer mentor program
BehavioralA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: 12-week TEAM peer mentor programExperimental treatment 1 intervention
Group B: 12-week waitlist controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
during the study period of approximately three years.2
Adherence to the intervention arms
Defined as the percentage of prescribed sessions that adolescents attended during the trial period of approximately three years
Time frame
during the study period of approximately three years3
Retention for follow-up measurements
Defined as the percentage of adolescents who complete follow-up measurements during the study period of approximately three years.
Time frame
during the study period of approximately three years.Secondary outcomes
1
Physical activity
Daily moderate to vigorous physical activity measured for seven days with a waist mounted accelerometer
Time frame
Baseline, week 12, week 242
Quality of Life (DQOL)
The Health-Related Quality of Life in persons living with diabetes (DQOL) will be used to measure overall quality of life. Lower scores indicate better quality of life.
Time frame
Baseline, week 12, week 243
Quality of Life (PedsQL 4.0)
Quality of Life (PedsQL 4.0) will be used to measure the condition-specific quality of life. Lower scores indicate better quality of life.
Time frame
Baseline, week 12, week 24Other outcomes
1
Diabetes Distress
The Problem Areas in Diabetes-Teen (PAID-peds) survey has the best psychometric properties for adolescents and young adults. With the PAID-T, adolescents use a 6-point scale (1 -not a problem to 6 -a serious problem) to rate various sources of distress over the past month.
Time frame
Baseline, week 12, week 242
Mastery
The Perceived Competence for Diabetes Scale (PCDS) assesses the degree to which people with diabetes feel they can manage the everyday aspects of diabetes care. The PCDS contains four statements, rated on a 7-point Likert scale, with higher scores representing better respondent performance.
Time frame
Baseline, week 12, week 243
Autonomy
The Treatment Self-Regulation Questionnaire (TSRQ) is a theoretically derived scale that assesses the degree of autonomous self-regulation regarding why people engage or would engage in healthy behavior and is designed to assess the different forms of motivation within SDT.
Time frame
Baseline, week 12, week 244
Motivation for physical activity (LCE)
The Locus of Causality for Exercise Scale (LCE) is a brief, three-item scale designed to assess the extent to which individuals feel that they freely choose to exercise rather than feeling that they have to for an external reason (i.e. parents/external expectations). Higher scores indicate higher self-determination.
Time frame
Baseline, week 12, week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manitoba
Lead sponsor
Juvenile Diabetes Research Foundation
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov