NCT05319600

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2022-04-18
• Primary completion: 2023-07-20
• Completion: 2024-03-21
• First posted: 2022-04-08
• Last updated: 2025-03-26
• Results posted: 2024-12-24

Locations

1 site across 1 country: United States