Avatar-based Social Physical Activity

NCT ID: NCT05662826

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2026-12-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Avatar-based Social Physical Activity

Group classes with virtual reality exercise games, talking, acting, and painting activities

Group Type: EXPERIMENTAL

Avatar-based Social Physical Activity

Intervention Type: BEHAVIORAL

Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.

Interventions

Avatar-based Social Physical Activity

Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale Children's Diabetes Program

New Haven, Connecticut, United States

Countries

United States

References

Chin WW, Salisbury WD, Pearson AW, Stollak MJ. Perceived cohesion in small groups: Adapting and testing the perceived cohesion scale in a small-group setting. Small Group Research. 1999;30(6):751-766.

Reference Type: BACKGROUND

Staiano, AE, Adams, MA, & Norman, GJ (2019). Motivation for Exergame Play Inventory: Construct validity and relationship to game play. Cyberpsychology: Journal of Psychosocial Research on Cyberspace, 13(3), article 7.

Reference Type: BACKGROUND

Makransky, G., Lilleholt, L., & Aaby, A. (2017). Development and validation of the Multimodal Presence Scale for virtual reality environments: A confirmatory factor analysis and item response theory approach. Computers in Human Behavior, 72, 276-285.

Reference Type: BACKGROUND

Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.

Reference Type: BACKGROUND

Other Identifiers

2000033736

Identifier Type: -

Identifier Source: org_study_id