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

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status

Not yet enrolling

Conditions

Type 1 Diabetes

Treatments

Other: NUDGE

Study type

Observational

Funder types

Other

Identifiers

NCT06018844
STUDY00002143

Details and patient eligibility

About

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

Enrollment

250 estimated patients

Sex

All

Ages

13 to 21 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Central trial contact

Claire Petty; Priscilla Connell, MPH

Data sourced from clinicaltrials.gov

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