Clinical trial NCT06018844: Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
Official title: Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas
name: Nemours Children's Clinic
First posted: 2023-08-31
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 12.00 to 21.99 with Type 1 Diabetes

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


Eligibility criteria: 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.

Primary outcomes:
measure: %daily text messages exchanged between youth and the NUDGE bot
timeFrame: Through study completion, an average of 3.5 months
measure: Moderate to Vigorous Physical Activity (MVPA) levels
timeFrame: Day 1, 30 and 90
Secondary outcomes:
measure: %days that youth wear the actigraph
timeFrame: Day 1, 30 and 90
measure: %daily physical activity (PA) schedules that participants complete
timeFrame: Day 1, 30 and 90
measure: Change in participant HbA1c
timeFrame: Through study completion, an average of 3.5 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
Study officials:
affiliation: Children's Mercy
name: Mark Clements, MD
role: PRINCIPAL_INVESTIGATOR
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