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N/A Completed N=31 Randomized Treatment

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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