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

Study Overview
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Brief Summary
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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

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: NUDGE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: NUDGE|NUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %daily text messages exchanged between youth and the NUDGE bot | percent of daily text messages exchanged between youth and the NUDGE bot | Through study completion, an average of 3.5 months | 
| Moderate to Vigorous Physical Activity (MVPA) levels | Participants' MVPA levels | Day 1, 30 and 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %days that youth wear the actigraph | Percent of days that youth wear the actigraph | Day 1, 30 and 90 | 
| %daily physical activity (PA) schedules that participants complete | percent of daily PA schedules that participants complete | Day 1, 30 and 90 | 
| Change in participant HbA1c | Change in participant HbA1c | Through study completion, an average of 3.5 months |