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TerminatedNo phase

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

Reason given: PI decision based on reduced staffing and funds.

Key facts

Where
Kansas City, United StatesSee the site

Where in United States

  • Children's MercyKansas City, United StatesNo longer taking part

Trial details

Who runs it
Children's Mercy Hospital Kansas City
Trial code
NCT06018844
Record updated
19 August 2025
Original description
The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D)Read full original descriptionShow less

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

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT06018844