N/A
Completed N=31
Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes
Source: ClinicalTrials.gov NCT05319600 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Change From Baseline in Physical Activity — 209.08; 79.84 minutes — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Physical Activity |
209.08; 79.84 | <0.05 sig |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05319600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.