Avatar-based Social Physical Activity

Not Applicable

Suspended

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Avatar-based Social Physical Activity

• Registration Number: NCT05662826
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-23
• Study Start: 2023-01-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avatar-based Social Physical Activity	Avatar-based Social Physical Activity	Group classes with virtual reality exercise games, talking, acting, and painting activities

Primary Outcome Measures

Name	Time	Method
Engagement	4 weeks	Number of classes attended
Satisfaction	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.

Secondary Outcome Measures

Name	Time	Method
Motivation for exergame play	4 weeks	Score on motivation for exergame play inventory (reference 2). Scores range from 0 to 4. A higher score indicates greater motivation to play the videogame.
Multimodal presence	4 weeks	Score on multimodal presence scale (reference 3). Scores range from 0 to 4. A higher score indicates greater feeling of presence in the virtual world.
Perceived cohesion	4 weeks	Score on perceived cohesion scale (reference 1). Scores range from 0 to 6. A higher score indicates greater cohesion the participant felt among the group.
System usability	4 weeks	Score on system usability scale (reference 4). Scores range from 0 to 4. A higher score indicates the system was more feasible to use.

Trial Locations

Locations (1)

Yale Children's Diabetes Program; 🇺🇸 New Haven, Connecticut, United States