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OpenTrials
Completed

NCT Number: NCT05163912

Virtual Physical Activity for 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual home intervention

Behavioral

Group classes with active videogames and discussions

Primary outcomes

  1. Adherence

    Time frame: 6 weeks

    Number of group classes attended

  2. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Robert E. Leet and Clara Guthrie Patterson Trust

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2021
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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