Virtual Physical Activity for Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05163912
• Other study ID #: 2000030105
• Secondary ID: 852679
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Virtual home intervention
Group classes with active videogames and discussions

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Robert E. Leet and Clara Guthrie Patterson Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Number of group classes attended	6 weeks
Primary	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.	6 weeks