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

NCT06018844 | Terminated Results

• 1 other identifier: STUDY00002143
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• %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

• Moderate to Vigorous Physical Activity (MVPA) Levels

  Participants' MVPA levels

  Day 1, 30 and 90

Secondary Outcomes (3)

• %Days That Youth Wear the Actigraph

  Day 1, 30 and 90

• %Daily Physical Activity (PA) Schedules That Participants Complete

  Day 1, 30 and 90

• Change in Participant HbA1c

  Through study completion, an average of 3.5 months

Interventions

NUDGE OTHER

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.

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients 12.00 to 21.99 with Type 1 Diabetes

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64111, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Priscilla Connell
• Organization: Children's Mercy Research Institute

Endocrine-RisingT1deAlliance@cmh.edu

8166014543

Study Officials

• Mark Clements, MD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 31, 2023
• Study Start: July 25, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Locations

US (1)