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

NCT ID: NCT06018844

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2025-06-26

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

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas

OTHER

Sponsor Role: collaborator

Nemours Children's Clinic

OTHER

Sponsor Role: collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Clements, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy

Locations

Children's Mercy

Kansas City, Missouri, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

STUDY00002143

Identifier Type: -

Identifier Source: org_study_id