Actively Recruiting

Phase Not Applicable
Age: 3Years - 4Years
All Genders
Healthy Volunteers
ID06667661

A Home-Based Intervention to Improve Adherence to the 24-Hour Movement Guidelines in Young Children

Led by University of Kansas Medical Center · Updated on 2025-12-11

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a 12-week home-based mobile health (mHealth) intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children (3-4 years old) who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Children's physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their child's movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the intervention's impact and app feasibility over the 12-week period.

CONDITIONS

Brief Title

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

Who Can Participate

Age: 3Years - 4Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is 3 to 4 years old
  • Child currently meets 0 or 1 of the 24-Hour Movement Guidelines for physical activity, sleep, and screen-time
  • Parent agrees to use their mobile phone and download the study app for about 12 weeks
  • Parent or caregiver is fluent in English
  • Parent or caregiver is willing to travel to the study site for visits
Not Eligible

You will not qualify if you...

  • Child has mobility limitations reported by the parent
  • Child meets two or more of the 24-Hour Movement Guidelines for physical activity, sleep, and screen-time
  • A sibling or household member is participating or has participated in this study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants in the intervention group use the Shining Star mobile app for 12 weeks, receiving weekly lessons and behavior-related goals to improve adherence to the 24-Hour Movement Guidelines. Parents engage with the app’s gamification features, behavior trackers, and forums. Assessments of physical activity, sleep, screen time, motor skills, cognition, behavioral problems, and executive function are conducted at baseline, Week 6, and Week 12.

3 visits (baseline, Week 6, and Week 12)

Outpatient Treatment

Duration - 12 weeks

Participants in the wait-list control group do not receive the intervention during the initial 12 weeks but complete the same assessments of physical activity, sleep, screen time, motor skills, cognition, behavioral problems, and executive function at baseline, Week 6, and Week 12. After this period, they gain access to the mobile app.

3 visits (baseline, Week 6, and Week 12)

Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

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Research Team

D

Dr. Chelsea L Kracht, PhD

J

Jesse D Lyle, MHSA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

A Home-Based Intervention to Improve Adherence to the 24-Hour Movement Guidelines in Young Children: Protocol for a Mobile App-Based Randomized Control Trial.

Chelsea L Kracht, Jerica M Berge, Monique LeBlanc...

https://pubmed.ncbi.nlm.nih.gov/41610419