Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT06018844
- Lead Sponsor
- Children's Mercy Hospital Kansas City
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Moderate to Vigorous Physical Activity (MVPA) levels Day 1, 30 and 90 Participants' MVPA levels
%daily text messages exchanged between youth and the NUDGE bot Through study completion, an average of 3.5 months percent of daily text messages exchanged between youth and the NUDGE bot
- Secondary Outcome Measures
Name Time Method %daily physical activity (PA) schedules that participants complete Day 1, 30 and 90 percent of daily PA schedules that participants complete
Change in participant HbA1c Through study completion, an average of 3.5 months Change in participant HbA1c
%days that youth wear the actigraph Day 1, 30 and 90 Percent of days that youth wear the actigraph
Trial Locations
- Locations (1)
Children's Mercy
🇺🇸Kansas City, Missouri, United States