Avatar-based Social Physical Activity (ASPA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Avatar-based Social Physical Activity

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Children's Diabetes Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avatar-based Social Physical Activity; Group classes with virtual reality exercise games, talking, acting, and painting activities	Behavioral: Avatar-based Social Physical Activity; Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Number of classes attended	4 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Heart Association

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Exercise; Video games; Self-management; Social support
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2000033736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No