Recruiting

mHealth Intervention

Sponsor:

University of Kansas Medical Center

Code:

NCT06667661

Conditions

Healthy

24-Hour Movement Guidelines

Feasibility Studies

Sleep

Physical Activity

Eligibility Criteria

Sex: All

Age: 3 - 4

Healthy Volunteers: Accepted

Interventions

Shining Star mHealth App

Study Details

Brief summary:

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are:

  • Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)?
  • Is the intervention feasible for parents to implement, as measured by a parent feedback survey?

Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence.

Parents and Participants:

  • Children will wear an accelerometer to track physical activity and sleep patterns.
  • Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children.
  • Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks.
  • Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

Conditions

Healthy

24-Hour Movement Guidelines

Feasibility Studies

Sleep

Physical Activity

Study ID

NCT06667661

Start date

Jan 29, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 4

Healthy Volunteers: Accepted

Inclusion (Child):

  • Ages 3-4 years.
  • Parent report that they meet 0 or 1 recommendation for physical activity, sleep, and screen-time as defined by the 24-hour movement guidelines. The physical activity recommendation is defined as greater than or equal to 3 hours/day of total physical activity, including 1 hour of moderate-to-vigorous physical activity. The sleep recommendation is defined as 10-13 hours/day. The sedentary behavior recommendation is defined as less than or equal to 1 hour/day of sedentary screen-time.

Inclusion (Parents):

  • Parents must agree to use their mobile phone for the duration of the study (\~12 weeks) and download the mobile app onto their phone.
  • The parent/caregiver is fluent in English to participate in testing the mobile app.
  • The parent/caregiver must be willing to travel to KUMC to complete study visits.

Exclusion (child):

  • Mobility limitations as reported by the parent.
  • Meeting two or more recommendations for physical activity, sleep, and screen-time.
  • Sibling or household member is participating or participated in the study.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 12-Week Intervention

Participants in the intervention group will receive access to the "Shining Star" mobile health application for 12 weeks. The app provides weekly lessons and behavior-related goals focused on improving adherence to the 24-Hour Movement Guidelines (physical activity, screen time, and sleep). Parents will receive concise messages (less than 500 characters) through the app, along with links to additional resources, gamification elements, and behavior trackers. Participants and participants will also complete physical activity and sleep assessments using accelerometers and questionnaires at baseline, Week 6, and Week 12.

no intervention: Wait-list Control

Participants in the wait-list control group will receive no intervention during the initial 12 weeks. They will complete the same assessments (physical activity, screen time, sleep, motor skills, and cognition) at baseline, Week 6, and Week 12. After the 12-week period, they will be granted access to the Shining Star mobile app and receive all lessons and resources provided to the intervention group.

Interventions

Shining Star mHealth App

The Shining Star mHealth App Intervention is a 12-week mobile health program designed to improve adherence to the 24-Hour Movement Guidelines (physical activity, screen time, and sleep) among preschool-aged children (3-4 years old). The intervention delivers weekly behavior-related goals and educational lessons to parents through a mobile app, including concise messages (\<500 characters) and links to additional resources. The app also includes gamification features, behavior trackers, and a \"Kids Corner\" for child-friendly content. Parents receive reminders and can engage with other participants through an optional chat forum.

Primary outcome measure

  • Physical Activity (ActiGraph GT3X+ accelerometer) [ Time Frame: Baseline, Week 6, and Week 12 ]
  • Sleep (ActiGraph GT3X+ accelerometer) [ Time Frame: Baseline, Week 6, and Week 12 ]
  • Screen Time [ Time Frame: Baseline, Week 6, and Week 12 ]
  • Feasibility and Acceptability of the Mobile App (Weekly Surveys) [ Time Frame: Weekly ]
  • Usability of the Mobile App (System Usability Scale) [ Time Frame: Week 6 and Week 12 ]

Central Contacts and Locations

Central contacts

Dr. Chelsea L Kracht, PhD

913-588-1655ckracht@kumc.edu

Jesse D Lyle, MHSA

785-766-1944jlyle5@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Dr. Chelsea L Kracht, PhD

913-588-1655ckracht@kumc.edu

Jesse D Lyle, MHSA

785-766-1944jlyle5@kumc.edu

Principal Investigator:

Dr. Chelsea L Kracht, PhD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • Physical Activity
  • Sedentary Behavior
  • Sleep
  • Child Development
  • Motor Skills
  • Behavioral problems
  • Healthy
  • 24-Hour Movement Guidelines
  • Screen Time
  • Sedentary Behaviors
  • Cognition
  • Parent-Child Relations
  • Mobile Application
  • Health Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-12-11.