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Clinical Trials/NCT05163912
NCT05163912
Completed
Not Applicable

A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes

Yale University2 sites in 1 country15 target enrollmentJanuary 4, 2022
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Yale University
Enrollment
15
Locations
2
Primary Endpoint
Adherence
Status
Completed
Last Updated
last year

Overview

Brief Summary

A virtual group of teens with type 1 diabetes, led by young adults with type 1 diabetes, will play active videogames and discuss activity and health. This study will evaluate the program for feasibility and user satisfaction.

Registry
clinicaltrials.gov
Start Date
January 4, 2022
End Date
August 5, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age of 14-19 years
  • Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
  • Inadequate moderate-to-vigorous physical activity levels (defined as ≤3 days per week achieving ≥60min daily, which is ≤50% of the recommended 7 days per week)
  • English literacy
  • Own a continuous glucose monitor (Dexcom G4, G5, G6 \[San Diego, CA\], Abbott Freestyle Libre 2, 14-day \[Chicago, IL\], Medtronic Guardian 3, Enlite \[Dublin, Ireland\]) with enough supplies for 6 weeks (when available, we will provide these to those who do not own them, in which case they will be considered to meet this criteria).
  • Access to television or computer with HDMI or USB port.
  • Under regular care by a healthcare provider (defined as attending at least one appointment in the past year, plus access to verified 24hr phone number to reach the provider's team for insulin dose adjustments if assistance is needed)

Exclusion Criteria

  • A condition or disability besides type 1 diabetes that would preclude participation in group moderate-to-vigorous physical activity (e.g., cerebral palsy, current pregnancy)

Outcomes

Primary Outcomes

Adherence

Time Frame: 6 weeks

Number of group classes attended

Acceptability

Time Frame: 6 weeks

Score on a satisfaction survey that has been custom-designed for the components of this program. Scores range from 0 to 4. A higher score indicates greater satisfaction with the program.

Study Sites (2)

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