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Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes
NA trial testing Diabetes behavior change skills training in Type 1 Diabetes in 31 participants. Completed in 21 March 2024.
| Lead sponsor | University of Vermont |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 18 April 2022 |
| Primary completion | 20 July 2023 |
| Estimated completion | 21 March 2024 |
| Sites | 1 location across United States |
University of Vermont
Adults 13 to 17, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 209.08 | 105.49 – 312.66 |
| Treatment as Usual - Control | 79.84 | -30.91 – 190.59 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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