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

NCT ID: NCT06667661

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2026-12-31

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.

Detailed Description

The Shining Star study is a randomized controlled trial designed to evaluate the feasibility and preliminary effectiveness of a 12-week home-based mHealth intervention aimed at improving adherence to the 24-Hour Movement Guidelines (physical activity, sedentary behavior, and sleep) among preschool-aged children (3-4 years old). The trial consists of two groups: an intervention group receiving the mHealth intervention and a waitlist control group.

The primary objective is to determine if the intervention increases the proportion of children meeting all three 24-Hour Movement Guidelines. The intervention focuses on engaging parents through a mobile app, which delivers weekly lessons and behavior-related goals to promote healthy movement behaviors in children. Secondary objectives include assessing changes in child motor skills, cognition, behavioral problems and executive function, and BMI.

Study Design and Procedures:

Participants will be randomly assigned to either the intervention group or a waitlist control group. The intervention group will use the Shining Star mobile app, which provides short, weekly messages (less than 500 characters) and links to additional resources. The app will also include gamification elements, behavior trackers, and a forum for parents to connect with each other. Participants in the control group will receive access to the app after the 12-week intervention period.

Key measurements will be taken at three time points: baseline (Week 0), mid-point (Week 6), and at the end of the intervention (Week 12). Measurements include accelerometer data to assess physical activity, sedentary time, and sleep, anthropometrics to assess BMI, as well as parent-reported screen time, child motor skills, behavioral problems and executive function, and cognition. Usability and feasibility of the mobile app will be assessed through weekly app usage and feedback questionnaires.

Sample Size and Statistical Plan:

A total of 80 parent-child dyads (40 per group) will be enrolled in the study. A sample size of 30 families per group is expected to provide 80% power to detect a meaningful difference in the proportion of children meeting all three recommendations after 12 weeks. Based on a projected dropout rate of 25%, the target enrollment is 80 families.

Statistical analysis will focus on two primary hypotheses:

1. Whether a greater proportion of children in the intervention group meet the 24-Hour Movement Guidelines compared to the control group at 12 weeks.

2. Whether parents report that the intervention is feasible, with a target feasibility rating of ≥4.0/5.0 on a Likert scale.

Additional exploratory analyses will evaluate changes in child motor skills, behavioral problems, cognition, and growth as well as home-level and parent-level correlates.

Quality Assurance and Data Management:

Data will be collected using validated measures, and all data will be securely stored in REDCap. Clinical data collected at screening and follow-up visits, including accelerometer data and questionnaires, will be stored in a secure database at the University of Kansas Medical Center (KUMC). The data will undergo validation and consistency checks before analysis.

• Quality Assurance Plan: The research coordinator will ensure that accurate and complete data is transcribed from paper sources into REDCap. To maintain data quality, accuracy, and integrity, data entry will be performed twice. The REDCap data comparison tool will then be used to produce a final "Clean" entry.
• Missing Data Plan: Participants who do not complete the required assessments at baseline (Week 0), mid-point (Week 6), and end of the intervention (Week 12) will be excluded from the final analysis. Efforts will be made to retain participants throughout the study to minimize missing data.
• Statistical Analysis Plan: The primary analysis will compare the proportion of participants in the intervention and control groups meeting all three recommendations at 12 weeks using chi-square analysis. The secondary analysis will average the Likert scale responses across all weeks completed. Exploratory analyses will utilize linear regression to examine changes in outcomes between the treatment and control groups, along with iso-temporal substitution analysis to assess the impact of behavior substitution on child developmental outcomes. Additionally, the investigators will examine the relationship between meeting specific movement recommendations and child outcomes, with changes in theoretical components as potential mediators. Statistical significance will be set at p = 0.05 for analyses.

The study will also adhere to KUMC standard operating procedures for data collection, data analysis, and confidentiality as outlined in the study protocol.

Conditions

Healthy; 24-Hour Movement Guidelines; Feasibility Studies; Sleep; Physical Activity; Screen Time; Sedentary Behaviors; Motor Skills; Cognition; Parent-Child Relations; Mobile Application; Health Education; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shining Star mHealth App

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

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

NIH

Sponsor Role: collaborator

Responsible Party

Chelsea L. Kracht, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Chelsea L Kracht, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dr. Chelsea L Kracht, PhD

Role: CONTACT

ckracht@kumc.edu

913-588-1655

Jesse D Lyle, MHSA

Role: CONTACT

jlyle5@kumc.edu

785-766-1944

Facility Contacts

Dr. Chelsea L Kracht, PhD

Role: primary

ckracht@kumc.edu

913-588-1655

Jesse D Lyle, MHSA

Role: backup

jlyle5@kumc.edu

785-766-1944

Study Documents

Document Type: NIH Reporter Information

Final Data set will be deposited into NICHD DASH database.

View Document

Other Identifiers

R00HD107158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00160250

Identifier Type: -

Identifier Source: org_study_id