Virtual Physical Activity for Type 1 Diabetes

August 26, 2024 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
      • New Haven, Connecticut, United States, 06511
        • Yale-New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Virtual home intervention
Behavioral: Virtual home intervention
Group classes with active videogames and discussions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 6 weeks
Number of group classes attended
6 weeks
Acceptability
Time Frame: 6 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Robert E. Leet and Clara Guthrie Patterson Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000030105
  • 852679 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe