Mobile App for Child Development (Shining Star Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Kansas Medical Center
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
311121314Eligibility Criteria
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
My child is between 3 and 4 years old.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: 12-Week InterventionExperimental Treatment1 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 ControlActive Control1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Kansas Medical CenterKansas City, KS
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
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]To assess the functionality and feasibility of the GROWIN app for promoting early detection of growth disorders in childhood, supporting early interventions, and improving children's lifestyle by analyzing data collected over 3 years (2018-2020).
The effectiveness of user-focused mobile health applications in paediatric chronic disease management: A systematic review. [2022]This systematic review aims to evaluate the effectiveness of user-focused mobile health (mHealth) applications in paediatric chronic disease management.
Using Mobile Health to Promote Early Language Development: A Narrative Review. [2019]In this narrative review, we first present a brief overview of known disparities in children's language development based on socioeconomic status and efforts in the primary care setting to promote children's language development. Next, we define mobile health (m-health) and review the limited, published literature regarding the effectiveness of m-health interventions in promoting children's health, in general, and language development, in particular. Finally, we discuss the potential role of smartphone applications to increase parental behaviors that promote their children's language development, as well as challenges that should be addressed as the field of m-health continues to grow.
Digital health intervention on patient safety for children and parents: A scoping review. [2023]To explore digital health interventions on patient safety for children and their parents.
Using an inpatient portal to engage families in pediatric hospital care. [2022]Assess parent use and perceptions of an inpatient portal application on a tablet computer that provides information about a child's hospital stay.
Development of a Pediatric Adverse Events Terminology. [2019]In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization.
An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. [2022]The Canadian National Vaccine Safety network (CANVAS) gathers and analyzes safety data on individuals receiving the influenza vaccine during the early stages of annual influenza vaccination campaigns with data collected via participant surveys through the Internet. We sought to examine whether it was feasible to use a mobile application (app) to facilitate AEFI reporting for the CANVAS network. To explore this, we developed a novel smartphone app, recruited participants from a hospital influenza immunization clinic and by word of mouth and instructed them to download and utilize the app. The app reminded participants to complete the CANVAS AEFI surveillance surveys ("AEFI surveys") on day 8 and 30, a survey capturing app usability metrics at day 30 ("usability survey") and provided a mechanism to report AEFI events spontaneously throughout the whole study period. All survey results and spontaneous reports were recorded on a privacy compliant, cloud server. A software plug-in, Lookback, was used to record the on-screen experience of the app sessions. Of the 76 participants who consented to participate, 48(63%) successfully downloaded the app and created a profile. In total, 38 unique participants completed all of the required surveillance surveys; transmitting 1104 data points (survey question responses and spontaneous reports) from 83 completed surveys, including 21 usability surveys and one spontaneous report. In total, we received information on new or worsening health conditions after receiving the influenza vaccine from 11(28%) participants. Of the usability survey responses, 86% agreed or strongly agreed that they would prefer to use a mobile app based reporting system instead of a web-based system. The single spontaneous report received was from a participant who had also reported using the Day 8 survey. Of Lookback observable sessions, an accurate transmission proportion of 100% (n=290) was reported for data points. We demonstrated that a mobile app can be used for AEFI reporting, although download and survey completion proportions suggest potential barriers to adoption. Future studies should examine implementation of mobile reporting in a broader audience and impact on the quality of reporting of adverse events following immunization.
Big Data in the Assessment of Pediatric Medication Safety. [2020]Big data (BD) in pediatric medication safety research provides many opportunities to improve the safety and health of children. The number of pediatric medication and device trials has increased in part because of the past 20 years of US legislation requiring and incentivizing study of the effects of medical products in children (Food and Drug Administration Modernization Act of 1997, Pediatric Rule in 1998, Best Pharmaceuticals for Children Act of 2002, and Pediatric Research Equity Act of 2003). There are some limitations of traditional approaches to studying medication safety in children. Randomized clinical trials within the regulatory context may not enroll patients who are representative of the general pediatric population, provide the power to detect rare safety signals, or provide long-term safety data. BD sources may have these capabilities. In recent years, medical records have become digitized, and cell phones and personal devices have proliferated. In this process, the field of biomedical science has progressively used BD from those records coupled with other data sources, both digital and traditional. Additionally, large distributed databases that include pediatric-specific outcome variables are available. A workshop entitled "Advancing the Development of Pediatric Therapeutics: Application of 'Big Data' to Pediatric Safety Studies" held September 18 to 19, 2017, in Silver Spring, Maryland, formed the basis of many of the ideas outlined in this article, which are intended to identify key examples, critical issues, and future directions in this early phase of an anticipated dramatic change in the availability and use of BD.
User preferences for a mobile application to report adverse events following vaccination. [2020]The passive surveillance system is an important tool in pharmacovigilance of vaccines. However, reporting of adverse events following immunization (AEFI) post-marketing has limitations regarding under-reporting, biased reports and lack of exposure data resulting in imprecise estimates. New mobile application technology may provide an opportunity for an enhanced surveillance. A pre-requisite for the use of new app-based technology is to identify practical challenges and end users' preferences for design of app-features. The objectives were (i) to investigate the recruitment and feasibility of an app-based study in Germany, (ii) to assess individuals' motivation to participate in such a study and (iii) to identify app-features for reporting AEFI. We conducted a cross-sectional study among employees of a financial institution who attended the occupational health office during the seasonal influenza vaccination in November 2017. Participants tested feasibility and assessed an app prototype for AEFI reporting by using a case vignette and a questionnaire. Of the 153 attending employees, 65 (42%) agreed to participate and returned the questionnaire. Twenty-three (63%) rated the experience of reporting AEFI with the app prototype to be positive. Among three features offered for gamification, collecting points was most frequently chosen (n=22, 34%). The main reason for declining participation was the apprehension about data protection (n=28, 43%). Results suggest that the app-based technology was well accepted and is a suitable supplement for AEFI reporting and in our study. A convincing data protection concept is likely to enhance acceptability of such a system.
Using Mobile Apps to Communicate Vaccination Records: A City-wide Evaluation with a National Immunization App, Maternal Child Registry and Public Health Authorities. [2022]Medicine is experiencing a paradigm shift, where patients are increasingly involved in the management of their health data. We created a mobile app which permitted parental reporting of immunization status to public health authorities. We describe app use as a proxy for feasibility and acceptability as well as data utility for public health surveillance. The evaluation period ran from April 27, 2015, to April 18, 2017, during which time 2,653 unique children's records were transmitted, containing 36,105 vaccinations. Our findings suggest that mobile immunization reporting is feasible and may be an acceptable complement to existing reporting methods. Measures of data utility suggest that mobile reporting could enable more accurate assessments of vaccine coverage.
Content Analysis of Apps for Growth Monitoring and Growth Hormone Treatment: Systematic Search in the Android App Store. [2021]The use of mobile apps for health is growing. This rapid growth in the number of health apps can make it hard to assess their quality and features. The increased demand for and availability of mobile health apps highlights the importance of regular publication of reviews to identify potential areas of unmet needs and concern. The focus of this review is mobile apps for monitoring growth for health care professionals, caregivers, and patients. Monitoring growth as a part of healthy physical development is important across different periods of childhood and adolescence.
Pediatric apps: what are they for? A scoping review. [2022]In recent years, there has been a surge in the development of mHealth apps. Nevertheless, there are no scoping reviews that analyze the scientific peer-reviewed articles of these tools. This research systematically reviews the scientific literature published on health apps targeting children in peer-reviewed journals. It aims to answer four questions: what is the primary purpose of these apps; for what medical specialties and main topics were they developed; whom do they target; and how they were analyzed. The study followed PRISMA methodology, and the search process used the Web of Science Core Collection. The selected terms for the search were "pediatr*" and "app." The initial search resulted in 303 papers which, after applying filters, excluded 187 papers. In the end, 116 articles were deemed appropriate for addressing our research questions and were thoroughly reviewed. The primary purpose of pediatric health apps is to support clinical decision-making, patient education, and patient self-management. The most frequent topics covered are cancer, obesity, and asthma. Hematological oncology and endocrinology are the most frequent medical specialties addressed. The apps mainly target children, their caregivers, or both groups. Most of the apps were analyzed using observational studies, predominantly conducted in the USA, with an average participant sample size of 842. No analyses of development costs were found. These findings can be helpful for the development of future pediatric health apps. What is Known: • Health care has become increasingly digital due to digital health technologies, which have helped to expand the scope of health care. • Digital health technology can be used to improve the health of children. • The increasing availability of smartphones for children and families may enable the use of apps to deliver, promote, and sustain interventions which could lead to long-term improvements in health. What is New: • The most frequent topics covered were cancer, obesity, and asthma. Hematology-oncology and endocrinology were the most frequent medical specialties addressed. • The principal aims of the pediatric health apps were to facilitate clinical decision support, patient education, and patient self-management. • The apps mainly targeted children, their caregivers, or both groups. • Most of them had been analyzed using observational studies.
Use of mobile app to monitoring growth outcome of children: A systematic literature review. [2022]Advances in knowledge and technology have created opportunities to help monitor child growth. Thus, we conducted a systematic review to determine if the use of mobile apps resulted in improved growth outcomes for children. We include articles published related to children's growth with poor nutritional status. The relevant articles were searched from PubMed, ScienceDirect, Scopus, ProQuest, and Google Scholar. Twelve studies were identified, which is the use of the mobile app to monitor growth in undernutrition and obesity in children. Six studies found that the use of mobile apps improved undernutrition child growth and improved parents' and/or front health workers' knowledge to prevent, treat, and monitor children with undernutrition. Six studies stated that the use of mobile app helps overweight/obese children lose weight and motivate them to achieve ideal body weight. Mobile apps for monitoring the growth of children with various standards are likely a promising means for early detection of growth failure and guiding overweight/obese children in gaining normal weight. Studies with large sample sizes and long-term interventions and follow-ups are needed to help assess the effectiveness of mobile app intervention programs and their impact on multiple growth outcomes more comprehensively and accurately.
An Analytics Platform to Evaluate Effective Engagement With Pediatric Mobile Health Apps: Design, Development, and Formative Evaluation. [2023]Mobile health (mHealth) apps for pediatric chronic conditions are growing in availability and challenge investigators to conduct rigorous evaluations that keep pace with mHealth innovation. Traditional research methods are poorly suited to operationalize the agile, iterative trials required to evidence and optimize these digitally mediated interventions.