A Home-Based Intervention to Improve Adherence to the 24-Hour Movement Guidelines in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Physical Activity (ActiGraph GT3X+ accelerometer)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Physical Activity (ActiGraph GT3X+ accelerometer)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Weight (kg)(Baseline, Week 6, and Week 12)
- Height (cm)(Baseline, Week 6, and Week 12)
- BMI (kg/m²)(Baseline, Week 6, and Week 12)
- Motor Skills - Grip Strength Test(Baseline, Week 6, and Week 12)
- Motor Skills - 9-Hole Pegboard Dexterity Test(Baseline, Week 6, and Week 12)
- Motor Skills - Standing Balance Test(Baseline, Week 6, and Week 12)
- 24-Hour Movement Behaviors(Week 6 and Week 12)
- Motor Skills - 2-Minute Walk Endurance Test(Baseline, Week 6, and Week 12)
- Cognition - Picture Vocabulary Test(Baseline, Week 6, and Week 12)
- Cognition - Flanker Inhibitory Control and Attention Test(Baseline, Week 6, and Week 12)
- Cognition - Dimensional Change Card Sort Test(Baseline, Week 6, and Week 12)
- Cognition - Picture Sequence Memory Test(Baseline, Week 6, and Week 12)
- Behavioral Problems - BASC-3(Baseline, Week 6, and Week 12)
- Executive Function - BRIEF-P(Baseline, Week 6, and Week 12)
研究者
Chelsea L. Kracht, PhD
Assistant Professor
University of Kansas Medical Center