NCT05319600Completed
Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes
Does a Behavior Change Skills and Physical Activity Program Improve Self-regulation and Health Outcomes in Adolescents With Type 1 Diabetes?
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 25 Mar 2022
- Start date
- 18 Apr 2022
- Primary completion date
- 20 Jul 2023
- Lead sponsor
- University of Vermont
- Diseases
- Type 1 diabetes
- NCT number
- NCT05319600
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 18 Apr 2022 to the primary completion date, 20 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe medical or psychiatric illness that limit participation (including any contraindications for physical activity)
Other
- Ward of state
- Active psychosis
Who the study is looking for
- 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
Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.