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

August 1, 2025 updated by: Children's Mercy Hospital Kansas City

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Children's Mercy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 12.00 to 21.99 with Type 1 Diabetes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%Daily Text Messages Exchanged Between Youth and the NUDGE Bot
Time Frame: Through study completion, an average of 3.5 months
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
Time Frame: Day 1, 30 and 90
Participants' MVPA levels
Day 1, 30 and 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%Days That Youth Wear the Actigraph
Time Frame: Day 1, 30 and 90
Percent of days that youth wear the actigraph
Day 1, 30 and 90
%Daily Physical Activity (PA) Schedules That Participants Complete
Time Frame: Day 1, 30 and 90
percent of daily PA schedules that participants complete
Day 1, 30 and 90
Change in Participant HbA1c
Time Frame: Through study completion, an average of 3.5 months
Change in participant HbA1c
Through study completion, an average of 3.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

Nemours Children's Clinic
University of Kansas

Investigators

  • Principal Investigator: Mark Clements, MD, Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2024

Primary Completion (Actual)

June 26, 2025

Study Completion (Actual)

June 26, 2025

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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