Back to resultsVirtual Physical Activity for Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual home intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Exercise, Adolescent, Video games, Self-management, Social support
Eligibility Criteria
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)
Sites / Locations
- Yale University
- Yale-New Haven Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Virtual home intervention
Outcomes
Primary Outcome Measures
Adherence
Number of group classes attended
Acceptability
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05163912
First Posted
December 9, 2021
Last Updated
August 8, 2023
Sponsor
Yale University
Collaborators
Robert E. Leet and Clara Guthrie Patterson Trust
1. Study Identification
Unique Protocol Identification Number
NCT05163912
Brief Title
Virtual Physical Activity for Type 1 Diabetes
Official Title
A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Robert E. Leet and Clara Guthrie Patterson Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Exercise, Adolescent, Video games, Self-management, Social support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Virtual home intervention
Intervention Type
Behavioral
Intervention Name(s)
Virtual home intervention
Intervention Description
Group classes with active videogames and discussions
Primary Outcome Measure Information:
Title
Adherence
Description
Number of group classes attended
Time Frame
6 weeks
Title
Acceptability
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Physical Activity for Type 1 Diabetes
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