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Suspended
Gap in funding

Avatar-based Social Physical Activity (ASPA)

ClinicalTrials.gov ID NCT05662826
Sponsor Yale University
Information provided by Yale University (Responsible Party)
Last Update Posted 2024-08-19
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Study Overview

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.
Official Title
A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes Part 2
Conditions
Type 1 Diabetes
Intervention / Treatment
  • Behavioral: Avatar-based Social Physical Activity
  • Behavioral: Avatar-based Social Physical Activity
Other Study ID Numbers
  • 2000033736
Study Start (Actual)
2023-01-17
Primary Completion (Estimated)
2025-12-30
Study Completion (Estimated)
2025-12-30
Enrollment (Estimated)
24
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Connecticut Locations
New Haven, Connecticut, United States, 06511

Yale Children's Diabetes Program
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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)
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Ages Eligible for Study
14 Years to 17 Years (Child )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Arms and Interventions

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

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
EngagementNumber of classes attended4 weeks
SatisfactionScore 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 cohesionScore 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 playScore 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 presenceScore 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 usabilityScore 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

This is where you will find people and organizations involved with this study.
Sponsor
Yale University
Collaborators
  • American Heart Association

Publications

General

These publications are provided voluntarily by the person who enters information about the study and may be about anything related to the study.

  • 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.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2022-12-14
First Submitted that Met QC Criteria
2022-12-14
First Posted
2022-12-23
Study Record Updates
Last Update Submitted that met QC Criteria
2024-08-16
Last Update Posted
2024-08-19
Last Verified
2024-08

More Information

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Keywords Provided by Yale University
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
Yes