Avatar-based Social Physical Activity

Type 1 Diabetes Clinical Trial

— ASPA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05662826
• Other study ID #: 2000033736
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Avatar-based Social Physical Activity
Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.

Locations

Country	Name	City	State
United States	Yale Children's Diabetes Program	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement	Number of classes attended	4 weeks
Primary	Satisfaction	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.	4 weeks
Secondary	Perceived cohesion	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.	4 weeks
Secondary	Motivation for exergame play	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.	4 weeks
Secondary	Multimodal presence	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.	4 weeks
Secondary	System usability	Score on system usability scale (reference 4). Scores range from 0 to 4. A higher score indicates the system was more feasible to use.	4 weeks