An interventional study of Shining Star mHealth App in Healthy, 24-Hour Movement Guidelines and Feasibility Studies, sponsored by University of Kansas Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 3 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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:
Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence.
Parents and Participants:
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:
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.
The study will also adhere to KUMC standard operating procedures for data collection, data analysis, and confidentiality as outlined in the study protocol.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion (Child):
Inclusion (Parents):
Exclusion (child):
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
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.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 6 and Week 12
Weight (kg)
Weight will be measured in kg to the nearest 0.1 kg using a MX115 by BEFOUR scale.
Time frame: Baseline, Week 6, and Week 12
Height (cm)
Height will be measured in cm to the nearest 0.1 cm using a wall-mounted stadiometer.
Time frame: Baseline, Week 6, and Week 12
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).
Time frame: Baseline, Week 6, and Week 12
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.
Time frame: Baseline, Week 6, and Week 12
Motor Skills - 9-Hole Pegboard Dexterity Test
An NIH Toolbox assessment of fine motor dexterity. Participants are asked to place 9 pegs into a Jamar® 9-Hole Peg Test Kit, then remove them as quickly as possible, one hand at a time.
Time frame: Baseline, Week 6, and Week 12
Motor Skills - Standing Balance Test
This NIH Toolbox assessment of balance involves participants performing a series of five progressively challenging poses on solid ground and a foam pad, with their eyes either open or closed. Each pose is held for 50 seconds, and postural sway is measured using an iPhone SE worn at the waist. Safety measures are in place to stop the test if necessary.
Time frame: Baseline, Week 6, and Week 12
24-Hour Movement Behaviors
Parents will report updates to their child's average daily time spent on physical activity, nighttime sleep, and screen use during a typical week.
Time frame: Week 6 and Week 12
Motor Skills - 2-Minute Walk Endurance Test
An NIH Toolbox assessment of cardiovascular endurance. Participants are asked to walk back and forth on a 50-foot course for two minutes, and the total distance walked is recorded in feet and inches.
Time frame: Baseline, Week 6, and Week 12
Cognition - Picture Vocabulary Test
An NIH Toolbox assessment of receptive vocabulary administered in a computer-adaptive test (CAT) format. Participants must choose which of four pictures best represents a word presented via audio.
Time frame: Baseline, Week 6, and Week 12
Cognition - Flanker Inhibitory Control and Attention Test
An NIH Toolbox assessment of inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it.
Time frame: Baseline, Week 6, and Week 12
Cognition - Dimensional Change Card Sort Test
An NIH Toolbox assessment of cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture.
Time frame: Baseline, Week 6, and Week 12
Cognition - Picture Sequence Memory Test
An NIH Toolbox assessment of episodic memory. Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented to them.
Time frame: Baseline, Week 6, and Week 12
Behavioral Problems - BASC-3
The Behavior Assessment System for Children, Third Edition (BASC-3) is a tool that uses a Likert scale, specifically the "Never" to "Almost Always" scale, to assess behavioral problems in children. The scale ranges from 0 to 3, with 0 indicating "Never" and 3 indicating "Almost Always." Higher scores suggest greater behavioral problems, indicating a worse outcome.
Time frame: Baseline, Week 6, and Week 12
Executive Function - BRIEF-P
The Behavior Rating Inventory of Executive Function-Parent Version (BRIEF-P) is a tool that uses a Likert scale, "Never" to "Often," to assess executive function behaviors in preschool-aged children. Higher scores suggest greater difficulties with executive functioning, indicating a worse outcome.
Time frame: Baseline, Week 6, and Week 12
Plan to share: Yes — Final data will be submitted to the NICHD DASH database.
Supporting information: Study protocol, Informed consent form
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.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 23 months is above that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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