Back to resultsAvatar-based Social Physical Activity (ASPA)
Primary Purpose
Type 1 Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avatar-based Social Physical Activity
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Exercise, Adolescent, Video games, Self-management, Social support
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)
Sites / Locations
- Yale Children's Diabetes Program
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avatar-based Social Physical Activity
Arm Description
Group classes with virtual reality exercise games, talking, acting, and painting activities
Outcomes
Primary Outcome Measures
Engagement
Number of classes attended
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05662826
First Posted
December 14, 2022
Last Updated
August 8, 2023
Sponsor
Yale University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT05662826
Brief Title
Avatar-based Social Physical Activity
Acronym
ASPA
Official Title
A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes Part 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Exercise, Adolescent, Video games, Self-management, Social support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avatar-based Social Physical Activity
Arm Type
Experimental
Arm Description
Group classes with virtual reality exercise games, talking, acting, and painting activities
Intervention Type
Behavioral
Intervention Name(s)
Avatar-based Social Physical Activity
Intervention Description
Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.
Primary Outcome Measure Information:
Title
Engagement
Description
Number of classes attended
Time Frame
4 weeks
Title
Satisfaction
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Perceived cohesion
Description
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.
Time Frame
4 weeks
Title
Motivation for exergame play
Description
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.
Time Frame
4 weeks
Title
Multimodal presence
Description
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.
Time Frame
4 weeks
Title
System usability
Description
Score on system usability scale (reference 4). Scores range from 0 to 4. A higher score indicates the system was more feasible to use.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Yale Children's Diabetes Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
Citation
Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.
Results Reference
background
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Avatar-based Social Physical Activity
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