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

Children's Mercy Hospital Kansas City

Status: Begins enrollment in 8 months

Conditions: Type 1 Diabetes

Treatments: Other: NUDGE

Study type: Observational

Funder types: Other

Identifiers

NCT06018844

STUDY00002143

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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.