Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus

Stopped early

Conditions studied: Type 1 Diabetes

In brief

The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D) The main question\[s\] it aims to answer are: * Does the intervention increase the amount of text messages between the mHealth software and participants? * Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants? * Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants? Participants will: * Receive text messages from the Nudge software * Report physical activity goals via the text messages to the Nudge software * Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation) * Complete surveys at the beginning of participation * Complete daily surveys while wearing the devices * Complete surveys at the end of participation * Record physical activity in study surveys

Key facts

Study ID

NCT06018844

Run by

Children's Mercy Hospital Kansas City

People needed

1

Starts

2024-07-25

Expected to finish

2025-06-26

Last updated by the study team

2025-08-19

Who can join

Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants 12.00-21.99 years old
• Participants with a physician confirmed T1D diagnosis.
• T1D diagnosis was at least 6 months prior to study enrollment
• Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
• Participants must be using a continuous glucose monitor (CGM)
• Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.

You may not qualify if…

• Participants with evidence of type 2 or monogenic diabetes.
• Participants with a comorbid chronic condition (e.g., renal disease).
• Participants with presence of severe psychiatric disorders.
• Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
• Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.

Where it is running

• Children's Mercy — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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