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

NCT06667661 | Recruiting

• 2 other identifiers: STUDY00160250R00HD107158
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (5)

• Physical Activity (ActiGraph GT3X+ accelerometer)

  Physical activity will be device-measured using an ActiGraph GT3X+ accelerometer. Participants will wear the accelerometer on their wrist with a Velcro band for 14 consecutive days after their baseline visit, Week 6 visit, and Week 12 visit, removing it only for water-based activities (e.g., bathing).

  Baseline, Week 6, and Week 12

• Sleep (ActiGraph GT3X+ accelerometer)

  Sleep will be device-measured using an ActiGraph GT3X+ accelerometer. Participants will wear the accelerometer on their wrist with a Velcro band for 14 consecutive nights after their baseline visit, Week 6 visit, and Week 12 visit.

  Baseline, Week 6, and Week 12

• Screen Time

  Parents will report the average amount of time per day their child spent viewing screens (television, tablet, video game, cellphone, and other) while sitting or lying down, considering the past 30 days.

  Baseline, Week 6, and Week 12

• Feasibility and Acceptability of the Mobile App (Weekly Surveys)

  Participant's randomized to the intervention will receive weekly surveys within the app to evaluate the feasibility and acceptability of the mobile health application. Parents will report how easy or difficult it was to achieve specific goals using a Likert scale ranging from 1 to 5, where 1 indicates a poor outcome and 5 indicates a better outcome.

  Weekly

• Usability of the Mobile App (System Usability Scale)

  Participants assigned to the intervention will rate their satisfaction with the app's design, appeal, and functionality using a 5-point Likert scale, which ranges from "Strongly Disagree" to "Strongly Agree." They will also complete the System Usability Scale (SUS), which also employs this 5-point Likert scale, at Week 6 and Week 12.

  Week 6 and Week 12

Secondary Outcomes (14)

• Weight (kg)

  Baseline, Week 6, and Week 12

• Height (cm)

  Baseline, Week 6, and Week 12

• BMI (kg/m²)

  Baseline, Week 6, and Week 12

• Motor Skills - Grip Strength Test

  Baseline, Week 6, and Week 12

• Motor Skills - 9-Hole Pegboard Dexterity Test

  Baseline, Week 6, and Week 12

Study Arms (2)

12-Week Intervention

EXPERIMENTAL

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.

Behavioral: Shining Star mHealth App

Wait-list Control

NO INTERVENTION

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 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.

12-Week Intervention

Eligibility Criteria

• Age: 3 Years - 4 Years
• Gender Eligibility Details: male and female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (1)

• Kracht CL, Berge JM, LeBlanc M, Newton RL Jr, Rhodes RE, Bolamperti G, Snodgrass M, Redman LM. 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. JMIR Res Protoc. 2026 Jan 29;15:e75621. doi: 10.2196/75621.

  PMID: 41610419 DERIVED

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Health Education; Problem Behavior

Condition Hierarchy (Ancestors)

Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavioral Symptoms; Child Behavior

Study Officials

• Dr. Chelsea L Kracht, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Chelsea L Kracht, PhD

CONTACT

913-588-1655; ckracht@kumc.edu

Jesse D Lyle, MHSA

CONTACT

785-766-1944; jlyle5@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized control trial with a waitlist control design.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 31, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 1 year after publication with no end date.
• Access Criteria: Data will be stored in the DASH data repository. Other requests for data and further information can be made to the PI, who will follow appropriate channels to distribute the data.

Locations

US (1)