HealthyShining StarNCT06667661
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
A study testing Shining Star mHealth App in people with Healthy and 24-Hour Movement Guidelines, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, 24-Hour Movement Guidelines, Feasibility Studies
- What is being tested?
- Shining Star mHealth App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- The parent/caregiver must be willing to travel to KUMC to complete study visits.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Home-Based Intervention to Improve Adherence to the 24-Hour Movement Guidelines in Young Children
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?
Read more
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.
Read the 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:
- Whether a greater proportion of children in the intervention group meet the 24-Hour Movement Guidelines compared to the control group at 12 weeks.
- 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
- Being tested
- Shining Star mHealth App
- 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
- Medical subject headings
- Motor Activity, Sedentary Behavior, Health Education, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shining Star mHealth AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 and Week 12
Secondary outcomes (14)
Weight (kg)
Weight will be measured in kg to the nearest 0.1 kg using a MX115 by BEFOUR scale.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start29 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control trial with a waitlist control design.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Chelsea L. Kracht, PhD, University of Kansas Medical Center
- Investigators
- Dr. Chelsea L Kracht, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667661
- Sponsor's protocol ID
- STUDY00160250
- Other IDs
- R00HD107158
- Acronym
- Shining Star
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data will be submitted to the NICHD DASH database.
Publications
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.
PubMed 41610419
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-Based Intervention to Improve Adherence to the 24-Hour Movement Guidelines in Young Children
- ClinicalTrials.gov ID
- NCT06667661
- Acronym / sponsor ID
- Shining Star / STUDY00160250
- Conditions
- Healthy, 24-Hour Movement Guidelines, Feasibility Studies, Sleep, Physical Activity, Screen Time
- Keywords
- Physical Activity, Sedentary Behavior, Sleep, Child Development, Motor Skills, Behavioral problems, Healthy, 24-Hour Movement Guidelines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether a greater proportion of children in the intervention group meet the 24-Hour Movement Guidelines compared to the control group at 12 weeks.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomized control trial with a waitlist control design.
| Arm | Type | Receives |
|---|---|---|
| 12-Week Intervention | Experimental | Behavioral: Shining Star mHealth AppParticipants 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. |
| 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. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- The parent/caregiver must be willing to travel to KUMC to complete study visits.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shining Star mHealth AppThe 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. | Behavioural | 12-Week Intervention |
Primary outcome
Physical Activity (ActiGraph GT3X+ accelerometer)
Time frame: Baseline, Week 6, and Week 12
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)
Time frame: Baseline, Week 6, and Week 12
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
Time frame: Baseline, Week 6, and Week 12
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)
Time frame: Weekly
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.
Usability of the Mobile App (System Usability Scale)
Time frame: Week 6 and Week 12
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.
14 secondary outcomes
Weight (kg)
Time frame: Baseline, Week 6, and Week 12
Height (cm)
Time frame: Baseline, Week 6, and Week 12
BMI (kg/m²)
Time frame: Baseline, Week 6, and Week 12
Motor Skills - Grip Strength Test
Time frame: Baseline, Week 6, and Week 12
Motor Skills - 9-Hole Pegboard Dexterity Test
Time frame: Baseline, Week 6, and Week 12
Motor Skills - Standing Balance Test
Time frame: Baseline, Week 6, and Week 12
24-Hour Movement Behaviors
Time frame: Week 6 and Week 12
Motor Skills - 2-Minute Walk Endurance Test
Time frame: Baseline, Week 6, and Week 12
Cognition - Picture Vocabulary Test
Time frame: Baseline, Week 6, and Week 12
Cognition - Flanker Inhibitory Control and Attention Test
Time frame: Baseline, Week 6, and Week 12
Cognition - Dimensional Change Card Sort Test
Time frame: Baseline, Week 6, and Week 12
Cognition - Picture Sequence Memory Test
Time frame: Baseline, Week 6, and Week 12
Behavioral Problems - BASC-3
Time frame: Baseline, Week 6, and Week 12
Executive Function - BRIEF-P
Time frame: Baseline, Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 41610419Kracht 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.
- Individual participant dataSharing planned: Yes. Final data will be submitted to the NICHD DASH database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Chelsea L Kracht, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shining Star mHealth App in people with Healthy and 24-Hour Movement Guidelines, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (ActiGraph GT3X+ accelerometer) (time frame: Baseline, Week 6, and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06667661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.