A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes Part 2

Yale University1 site in 1 country24 target enrollmentJanuary 17, 2023

ConditionsType 1 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Yale University
Enrollment: 24
Locations: 1
Primary Endpoint: Engagement
Status: Suspended
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is testing program where teens with type 1 diabetes play Meta Quest 2 virtual reality exercise games and talk, act, and paint about physical activity in virtual meetings with their peers and young adult role models. The outcomes are feasibility and user satisfaction.

Registry

clinicaltrials.gov

Start Date

January 17, 2023

End Date

December 30, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yale University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age of 14-17 years
•Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
•Moderate-to-vigorous physical activity less than half of recommended levels (defined as ≤3 days per week achieving ≥60min daily MVPA)
•English literacy
•Home Broadband wireless Internet (≥25 mbps downloads, ≥3 mbps uploads on google Internet speed test). This is used in \~98% of US households.
•Willing to use continuous glucose monitor for the duration of participation in the trial.
•Willing to use a computer or smartphone with web camera.
•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

Engagement

Time Frame: 4 weeks

Number of classes attended

Satisfaction

Time Frame: 4 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.