TERMINATED

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

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Conditions

Type 1 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-07-25
Study Completion:2025-06-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06018844

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.

Ages Eligible for Study:13 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants 12.00-21.99 years old
  2. * Participants with a physician confirmed T1D diagnosis.
  3. * T1D diagnosis was at least 6 months prior to study enrollment
  4. * Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
  5. * Participants must be using a continuous glucose monitor (CGM)
  6. * Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.
  1. * Participants with evidence of type 2 or monogenic diabetes.
  2. * Participants with a comorbid chronic condition (e.g., renal disease).
  3. * Participants with presence of severe psychiatric disorders.
  4. * Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
  5. * Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.

Contacts and Locations

Principal Investigator

Mark Clements, MD
PRINCIPAL_INVESTIGATOR
Children's Mercy

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

  • Mark Clements, MD, PRINCIPAL_INVESTIGATOR, Children's Mercy

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 Registration Dates

Study Start Date2024-07-25
Study Completion Date2025-06-26

Study Record Updates

Study Start Date2024-07-25
Study Completion Date2025-06-26

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes