A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers (NCT06667661) | Clinical Trial Compass
RecruitingNot Applicable
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
United States80 participantsStarted 2025-01-29
Plain-language 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.
Who can participate
Age range
3 Years – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physical Activity (ActiGraph GT3X+ accelerometer)
Timeframe: Baseline, Week 6, and Week 12
2
Sleep (ActiGraph GT3X+ accelerometer)
Timeframe: Baseline, Week 6, and Week 12
3
Screen Time
Timeframe: Baseline, Week 6, and Week 12
4
Feasibility and Acceptability of the Mobile App (Weekly Surveys)
Timeframe: Weekly
5
Usability of the Mobile App (System Usability Scale)