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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06018844
• Other study ID #: STUDY00002143
• Status: Not yet recruiting
• Start date: April 2025
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Claire Petty
• Phone: 816-601-4546
• Email: ckpetty[@]cmh.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Nemours Children's Clinic, University of Kansas

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%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
Primary	Moderate to Vigorous Physical Activity (MVPA) levels	Participants' MVPA levels	Day 1, 30 and 90
Secondary	%days that youth wear the actigraph	Percent of days that youth wear the actigraph	Day 1, 30 and 90
Secondary	%daily physical activity (PA) schedules that participants complete	percent of daily PA schedules that participants complete	Day 1, 30 and 90
Secondary	Change in participant HbA1c	Change in participant HbA1c	Through study completion, an average of 3.5 months