Clinical trial NCT05662826: Avatar-based Social Physical Activity
Official title: A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes Part 2
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Exercise
Adolescent
Video games
Self-management
Social support
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Engagement
timeFrame: 4 weeks
measure: Satisfaction
timeFrame: 4 weeks
Secondary outcomes:
measure: Perceived cohesion
timeFrame: 4 weeks
measure: Motivation for exergame play
timeFrame: 4 weeks
measure: Multimodal presence
timeFrame: 4 weeks
measure: System usability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Children's Diabetes Program
state: Connecticut
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.