Type 1 Diabetes
Conditions
Keywords
adolescents, physical activity intervention, diabetes self-management, behavior-change skills training
Brief summary
This project is comprised of a two-arm randomized control trial (RCT) testing the feasibility, acceptability, and preliminary efficacy of a nationally scalable program, Activate, a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents with type 1 diabetes. The researchers have a recruitment goal of 30 participants, but will enroll beyond 30 to address any withdrawal and ensure sample size is met. A primary goal of the study is assessing the feasibility and acceptability of the program, which combines two previously piloted components. Then, the investigators will compare the 12-week Activate program to a treatment as usual control group on proximal outcomes of behavior-change skills and daily active minutes. The investigators will also explore the impact of the Activate program on secondary mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills training and physical activity intervention will be acceptable, and effective at improving behavior-change skills and daily active minutes, as well as other mechanisms and outcomes linked with later type 1 diabetes health disparities.
Detailed description
Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health disparities in glycemic outcomes in adolescence and cardiovascular disease and diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death. Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that adolescents face with achieving optimal glycemic levels (\<20% nationally meet American Diabetes Association HbA1c targets), this is a critical population to support in health behavior change via psychosocial intervention during adolescence. Unfortunately, existing evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust multi-system approaches, have demonstrated limited efficacy for behavior change that results in improved glycemic outcomes and none have directly targeted cardiovascular health outside of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention innovation by testing a nationally-scalable diabetes behavior-change skills training and physical activity intervention program to improve glycemic outcomes and decrease cardiovascular disease risks for adolescents with type 1 diabetes including those with socioeconomic disadvantage . In this study the researchers will conduct a two-arm randomized trial with 30 adolescents with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control group. This study has 2 primary aims. First, the investigators will assess acceptability of the Activate program by examining participant engagement with the Activate program components. To assess the preliminary efficacy of the Activate program the investigators will examine changes in proximal outcomes of behavior-change skills (goal setting, problem-solving, and coping skills), and active minutes compared between treatment and control groups from baseline to a 12-week follow-up assessment. Second, the investigators will explore the impact of the Activate program on secondary mechanisms and outcomes linked with longer-term type 1 diabetes health disparities.
Interventions
BEHAVIORALDiabetes behavior change skills training
Behavior-change skills training will be provided through eight web-delivered content and activity sessions across the 12-week program. Sessions 1 through 4 will occur weekly and sessions 5 through 8 biweekly. Each session takes approximately 15-20 minutes for the adolescent to complete both content learning and related activities. These learning sessions focus on skills like problem solving and goal setting.
BEHAVIORALPhysical activity promotion program
The physical activity incentives program includes 12 weeks of personalized goals and incentives for increasing physically active minutes along with weekday text-based support. Active minutes, defined as minutes with moderate to vigorous physical activity, will be tracked via a Garmin fitness activity tracker.
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adolescents (aged 13-17) diagnosed with type 1 diabetes will all complete a baseline assessment where they will be randomized to complete a 12-week physical activity and behavior-change skills training intervention, or to follow their usual diabetes care plan for 12 weeks. Both groups will receive a Garmin fitness activity tracker wrist watch to track their physical activity over the 12-week study period. Follow-up assessments for all participants will take place after 12 weeks.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Aged 13-17 years old * At least 18 months post-diagnosis for type 1 diabetes * Parent reported moderate to no physical activity for adolescent * Ability to complete measures and intervention program in English * Access to broadband or cellular internet * Resides in and receives healthcare in the United States
Exclusion criteria
* Ward of state * Active psychosis * Severe medical or psychiatric illness that limit participation (including any contraindications for physical activity)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Physical Activity | daily for all days from week 1 through week 12 | The Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs. |
Countries
United States
Participant flow
Recruitment details
Pediatric endocrinology clinic and type 1diabetes community advertisements nationally.
Participants by arm
| Arm | Count |
|---|---|
| Intervention This arm will complete an intervention delivered remotely via an online website and online communication from the research team across the 12-week intervention period. This intervention has two parts, taking place simultaneously over the 12 weeks. First, participants will complete 8 web-delivered online behavior-change skills learning sessions which include reading and activities. Second, participants will be given daily and weekly personalized physical activity goals to meet, which will be tracked via their Garmin activity tracker and weekday text and if indicated video support. They have the opportunity to win money each week for meeting activity goals.
Diabetes behavior change skills training: Behavior-change skills training will be provided through eight web-delivered content and activity sessions across the 12-week program. Sessions 1 through 4 will occur weekly and sessions 5 through 8 biweekly. Each session takes approximately 15-20 minutes for the adolescent to complete both content learning and related activities. These learning sessions focus on skills like problem solving and goal setting.
Physical activity promotion program: The physical activity incentives program includes 12 weeks of personalized goals and incentives for increasing physically active minutes along with weekday text-based support. Active minutes, defined as minutes with moderate to vigorous physical activity, will be tracked via a Garmin fitness activity tracker. | 16 |
| Treatment as Usual - Control This arm will not complete an intervention. Participants will be instructed to wear a Garmin activity tracker but will be given no other specific instructions, other than to continue to follow their normal daily diabetes care plan. | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Treatment as Usual - Control | Total |
|---|---|---|---|
| Age, Continuous | 14.31 years STANDARD_DEVIATION 1.25 | 15.00 years STANDARD_DEVIATION 1.41 | 14.63 years STANDARD_DEVIATION 1.35 |
| Length since diagnosis | 5.33 years STANDARD_DEVIATION 2.68 | 6.92 years STANDARD_DEVIATION 2.42 | 6.07 years STANDARD_DEVIATION 2.65 |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Two or more races | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
| Sex/Gender, Customized Do not identify as female, male, or transgender | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Female | 5 Participants | 6 Participants | 11 Participants |
| Sex/Gender, Customized Male | 8 Participants | 6 Participants | 14 Participants |
| Sex/Gender, Customized Transgender | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 14 |
| other Total, other adverse events | 0 / 17 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 |
Outcome results
Primary
Change From Baseline in Physical Activity
The Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs.
Time frame: daily for all days from week 1 through week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intervention | Change From Baseline in Physical Activity | 209.08 minutes |
| Treatment as Usual - Control | Change From Baseline in Physical Activity | 79.84 minutes |
p-value: <0.0595% CI: [-22.52, 280.98]Regression, Linear