Mobile App for Child Development

(Shining Star Trial)

Overseen By Jesse D Lyle, MHSA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Mobility limitations, Meeting guidelines, Sibling participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

Is the Shining Star mHealth App safe for use in children?

There is no specific safety data available for the Shining Star mHealth App or its other names in the provided research articles. ^{1 2 3 4 5}

How does the Shining Star mHealth App treatment differ from other treatments for child development?

The Shining Star mHealth App is unique because it leverages mobile technology to promote early language development by increasing parental behaviors that support their children's language skills. Unlike traditional treatments, this app provides a digital, accessible platform for parents to engage in their child's development, addressing disparities based on socioeconomic status. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Shining Star mHealth App for child development?

Research shows that mobile health apps can be effective in managing children's health and promoting early language development, suggesting that similar apps like Shining Star could help with child development by encouraging positive parental behaviors. ^{6 11 12 13 14}

Who Is on the Research Team?

Dr. Chelsea L Kracht, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for preschoolers aged 3-4 who aren't meeting guidelines for physical activity, screen-time, and sleep. Parents willing to use a mobile app and complete surveys about their child's activities can participate. Children with certain health conditions or developmental issues may be excluded.

Inclusion Criteria

(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

(Child) 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) The parent/caregiver is fluent in English to participate in testing the mobile app

Exclusion Criteria

(Child) Meeting two or more recommendations for physical activity, sleep, and screen-time

(Child) Sibling or household member is participating or participated in the study

My child has difficulty moving around, as I've noticed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week home-based mHealth intervention using the Shining Star mobile app to improve adherence to the 24-Hour Movement Guidelines

12 weeks

3 visits (in-person) at baseline, Week 6, and Week 12

Follow-up

Participants are monitored for changes in physical activity, sleep, screen time, motor skills, cognition, and behavioral problems

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shining Star mHealth App

Trial Overview The Shining Star mHealth App is being tested to see if it helps kids follow the 24-Hour Movement Guidelines better. The study compares kids using the app with those on a waitlist, tracking their physical activity and sleep with an accelerometer.

How Is the Trial Designed?

Group I: 12-Week Intervention Experimental Treatment 1 Intervention

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.

Group II: Wait-list Control Active Control 1 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 Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The GROWIN app effectively promotes early detection of growth disorders in children, with 21,633 users entering growth measurements and receiving tailored recommendations, leading to 1,250 improvements in growth parameters.

In children with obesity, the app facilitated significant improvements in nutritional habits and a decrease in BMI over a year, demonstrating its potential for supporting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated growth monitoring app (GROWIN): a mobile Health (mHealth) tool to improve the diagnosis and early management of growth and nutritional disorders in childhood. de Arriba Muñoz, A., García Castellanos, MT., Cajal, MD., et al.[2023]

This systematic review evaluated seven studies involving 755 children with chronic diseases and found that user-focused mobile health (mHealth) applications can lead to clinically meaningful improvements in some health outcomes, although results varied widely across different conditions.

Despite some positive effects, the overall risk of bias in the studies was high, making it difficult to draw definitive conclusions about which specific populations would benefit most from these mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of user-focused mobile health applications in paediatric chronic disease management: A systematic review. Karataş, N., Kaya, A., İşler Dalgıç, A.[2022]

Children's language development is significantly influenced by socioeconomic status, highlighting the need for targeted interventions in primary care to support language growth.

Mobile health (m-health) interventions, particularly smartphone applications, show promise in enhancing parental behaviors that foster children's language development, although more research is needed to fully understand their effectiveness and address existing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Mobile Health to Promote Early Language Development: A Narrative Review. McClure, C., Cunningham, M., Bull, S., et al.[2019]

Digital health interventions, such as mobile apps and electronic health records, can enhance patient safety for children and their parents by providing preventive measures and risk management strategies, as identified in a scoping review of 13 studies.

These interventions can improve the continuity of care from hospitalization to home, thereby increasing children's safety and quality of care through better engagement with healthcare providers after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. Park, J., Jeon, H., Choi, EK.[2023]

A study involving 296 parents at a children's hospital showed that an inpatient portal application significantly improved parent satisfaction, with 90% of respondents finding it easy to use and 94% believing it enhanced care.

The portal facilitated better communication with healthcare teams, with 60% of parents reporting improved interactions, and 89% felt it helped reduce errors in care, particularly in monitoring medication lists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an inpatient portal to engage families in pediatric hospital care. Kelly, MM., Hoonakker, PL., Dean, SM.[2022]

The Pediatric Terminology Harmonization Initiative developed a comprehensive adverse event (AE) terminology specifically for pediatric care, containing over 1000 terms related to pediatric diseases and disorders, to improve international reporting and understanding of AEs.

This new terminology is designed for easy integration with existing biomedical vocabularies and is applicable in various healthcare settings, making it a valuable resource for enhancing pediatric clinical research and safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. Gipson, DS., Kirkendall, ES., Gumbs-Petty, B., et al.[2019]

A mobile app was developed to facilitate reporting of adverse events following immunization (AEFI) for the influenza vaccine, and it successfully recorded 1104 data points from 38 participants, indicating its feasibility for AEFI reporting.

Despite the app's success in data collection, only 63% of participants downloaded it, and only 28% reported new or worsening health conditions after vaccination, suggesting barriers to wider adoption that need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. Wilson, K., Atkinson, KM., Westeinde, J., et al.[2022]

Big data (BD) in pediatric medication safety research offers significant opportunities to enhance the safety and health of children, especially as legislation has increased the number of pediatric trials over the past 20 years.

Traditional clinical trials often fail to represent the general pediatric population or detect rare safety signals, but BD can address these limitations by utilizing digitized medical records and large databases to provide more comprehensive safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Big Data in the Assessment of Pediatric Medication Safety. McMahon, AW., Cooper, WO., Brown, JS., et al.[2020]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

A mobile app developed for parental reporting of children's immunization status was used to transmit records for 2,653 unique children, covering a total of 36,105 vaccinations over a two-year evaluation period, indicating its feasibility and acceptability.

The data collected through the app suggests that mobile immunization reporting could enhance the accuracy of vaccine coverage assessments, providing a valuable tool for public health surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Mobile Apps to Communicate Vaccination Records: A City-wide Evaluation with a National Immunization App, Maternal Child Registry and Public Health Authorities. Atkinson, KM., El-Khatib, Z., Barnum, G., et al.[2022]

A total of 76 mobile apps related to growth monitoring and growth hormone treatment were identified, with a high agreement rate in their relevance to the topic (Κ=0.97).

The majority of these apps (87%) are designed for patients and their families, indicating a strong focus on user-friendly tools for monitoring children's growth, which could enhance childhood health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content Analysis of Apps for Growth Monitoring and Growth Hormone Treatment: Systematic Search in the Android App Store. Fernandez-Luque, L., Labarta, JI., Palmer, E., et al.[2021]

A systematic review of 116 peer-reviewed articles on pediatric health apps revealed that their primary purposes are to support clinical decision-making, patient education, and self-management, with a focus on topics like cancer, obesity, and asthma.

Most of the analyzed apps target children and their caregivers, and the studies assessing these apps predominantly used observational methods, with an average participant sample size of 842, primarily conducted in the USA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric apps: what are they for? A scoping review. Nievas Soriano, BJ., Uribe-Toril, J., Ruiz-Real, JL., et al.[2022]

The systematic review of 12 studies indicates that mobile apps can significantly improve growth outcomes for children, particularly in addressing undernutrition by enhancing knowledge among parents and health workers.

Mobile apps also assist overweight and obese children in losing weight and achieving healthier body weights, suggesting they are effective tools for both preventing undernutrition and managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile app to monitoring growth outcome of children: A systematic literature review. Kustiawan, TC., Nadhiroh, SR., Ramli, R., et al.[2022]

The Analytics Platform to Evaluate Effective Engagement (APEEE) was developed to analyze engagement with the iCanCope app for young people with chronic pain, allowing for real-time data analysis and visualization.

Preliminary evaluations indicated that researchers found APEEE to be a valuable tool for enhancing the assessment of mHealth app engagement, which could lead to more effective and evidence-based care for pediatric chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analytics Platform to Evaluate Effective Engagement With Pediatric Mobile Health Apps: Design, Development, and Formative Evaluation. Pham, Q., Graham, G., Lalloo, C., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Automated growth monitoring app (GROWIN): a mobile Health (mHealth) tool to improve the diagnosis and early management of growth and nutritional disorders in childhood. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of user-focused mobile health applications in paediatric chronic disease management: A systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Using Mobile Health to Promote Early Language Development: A Narrative Review. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Using an inpatient portal to engage families in pediatric hospital care. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Big Data in the Assessment of Pediatric Medication Safety. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Using Mobile Apps to Communicate Vaccination Records: A City-wide Evaluation with a National Immunization App, Maternal Child Registry and Public Health Authorities. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Content Analysis of Apps for Growth Monitoring and Growth Hormone Treatment: Systematic Search in the Android App Store. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Pediatric apps: what are they for? A scoping review. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Use of mobile app to monitoring growth outcome of children: A systematic literature review. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

An Analytics Platform to Evaluate Effective Engagement With Pediatric Mobile Health Apps: Design, Development, and Formative Evaluation. [2023]