Type 1 DiabetesASPANCT05662826
Avatar-based Social Physical Activity
A study testing Avatar-based Social Physical Activity in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Avatar-based Social Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Children's Diabetes Program
New Haven, Connecticut, 06511
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Avatar-based Social Physical Activity
- Keywords
- Exercise, Adolescent, Video games, Self-management, Social support
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar-based Social Physical ActivityBehavioural
Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.
| Study group | Role | What they receive |
|---|---|---|
| Avatar-based Social Physical Activity | Experimental | Group classes with virtual reality exercise games, talking, acting, and painting activities Receives: Behavioral: Avatar-based Social Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Number of classes attended
Measured: 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.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start17 Jan 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Gap in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662826
- Sponsor's protocol ID
- 2000033736
- Acronym
- ASPA
- Status last verified
- Aug 2025
- First submitted
- 14 Dec 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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 at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes Part 2
- ClinicalTrials.gov ID
- NCT05662826
- Acronym / sponsor ID
- ASPA / 2000033736
- Conditions
- Type 1 Diabetes
- Keywords
- Exercise, Adolescent, Video games, Self-management, Social support
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Gap in funding
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatar-based Social Physical Activity | Experimental | Behavioral: Avatar-based Social Physical ActivityGroup classes with virtual reality exercise games, talking, acting, and painting activities |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar-based Social Physical ActivityExercise, group discussions, role-playing skits, and group painting done in a virtual setting. | Behavioural | Avatar-based Social Physical Activity |
Primary outcome
Engagement
Time frame: 4 weeks
Number of classes attended
Satisfaction
Time frame: 4 weeks
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 secondary outcomes
Perceived cohesion
Time frame: 4 weeks
Motivation for exergame play
Time frame: 4 weeks
Multimodal presence
Time frame: 4 weeks
System usability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- BackgroundChin 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.
- BackgroundStaiano, 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.
- BackgroundMakransky, 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.
- BackgroundBrooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar-based Social Physical Activity in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662826, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.