Virtual Physical Activity for Type 1 Diabetes

NCT ID: NCT05163912

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2022-08-05

Brief Summary

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A virtual group of teens with type 1 diabetes, led by young adults with type 1 diabetes, will play active videogames and discuss activity and health. This study will evaluate the program for feasibility and user satisfaction.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Virtual home intervention

Group Type EXPERIMENTAL

Virtual home intervention

Intervention Type BEHAVIORAL

Group classes with active videogames and discussions

Interventions

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Virtual home intervention

Group classes with active videogames and discussions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age of 14-19 years
* Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
* Inadequate moderate-to-vigorous physical activity levels (defined as ≤3 days per week achieving ≥60min daily, which is ≤50% of the recommended 7 days per week)
* English literacy
* Own a continuous glucose monitor (Dexcom G4, G5, G6 \[San Diego, CA\], Abbott Freestyle Libre 2, 14-day \[Chicago, IL\], Medtronic Guardian 3, Enlite \[Dublin, Ireland\]) with enough supplies for 6 weeks (when available, we will provide these to those who do not own them, in which case they will be considered to meet this criteria).
* Access to television or computer with HDMI or USB port.
* 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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert E. Leet and Clara Guthrie Patterson Trust

UNKNOWN

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Mak SS, Nally LM, Montoya J, Marrero R, DeJonckheere M, Joiner KL, Nam S, Ash GI. An Exergames Program for Adolescents With Type 1 Diabetes: Qualitative Study of Acceptability. JMIR Diabetes. 2025 May 28;10:e65665. doi: 10.2196/65665.

Reference Type DERIVED
PMID: 40238214 (View on PubMed)

Other Identifiers

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852679

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000030105

Identifier Type: -

Identifier Source: org_study_id

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