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

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06018844
Collaborator
University of Kansas (Other), Nemours Children's Clinic (Other)
250
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: NUDGE

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. %daily text messages exchanged between youth and the NUDGE bot [Through study completion, an average of 3.5 months]

    percent of daily text messages exchanged between youth and the NUDGE bot

  2. Moderate to Vigorous Physical Activity (MVPA) levels [Day 1, 30 and 90]

    Participants' MVPA levels

Secondary Outcome Measures

  1. %days that youth wear the actigraph [Day 1, 30 and 90]

    Percent of days that youth wear the actigraph

  2. %daily physical activity (PA) schedules that participants complete [Day 1, 30 and 90]

    percent of daily PA schedules that participants complete

  3. Change in participant HbA1c [Through study completion, an average of 3.5 months]

    Change in participant HbA1c

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's Mercy Hospital Kansas City
  • University of Kansas
  • Nemours Children's Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mark Clements, Principle Investigator, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT06018844
Other Study ID Numbers:
  • STUDY00002143
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Aug 31, 2023