NCT05662826

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

December 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

December 14, 2022

Last Update Submit

August 1, 2025

Conditions

Type 1 Diabetes

Keywords

ExerciseAdolescentVideo gamesSelf-managementSocial support

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Perceived cohesion

    4 weeks

  • Motivation for exergame play

    4 weeks

  • Multimodal presence

    4 weeks

  • System usability

    4 weeks

Study Arms (1)

Avatar-based Social Physical Activity

EXPERIMENTAL

Group classes with virtual reality exercise games, talking, acting, and painting activities

Behavioral: Avatar-based Social Physical Activity

Interventions

Avatar-based Social Physical ActivityBEHAVIORAL

Exercise, group discussions, role-playing skits, and group painting done in a virtual setting.

Avatar-based Social Physical Activity

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Children's Diabetes Program

New Haven, Connecticut, 06511, United States

Location

Related Publications (4)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 23, 2022

Study Start

January 17, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)