About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Shining Star mHealth App
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
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.
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.
Secondary outcomes
Weight (kg)
Weight will be measured in kg to the nearest 0.1 kg using a MX115 by BEFOUR scale.
Height (cm)
Height will be measured in cm to the nearest 0.1 cm using a wall-mounted stadiometer.
BMI (kg/m²)
Body mass index (BMI, kg/m²) will be calculated from the participant's collected height and weight measurements. These values will be combined to compute BMI, which will then be compared to national growth standards to determine the BMI z-score and categorize weight status (underweight, normal weight, overweight, or obesity).
Motor Skills - Grip Strength Test
An NIH Toolbox assessment of upper extremity strength. Participants are asked to squeeze a Jamar® Plus+ Digital Hand Dynamometer as hard as they can, one hand at a time.
Sponsors and contacts
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University of Kansas Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator