- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05805592
Эффект программы «Экран для перемещения» у детей дошкольного возраста
Влияние программы «Экран для перемещения» (STEP) на время использования экрана и физическую активность детей дошкольного возраста
The aim of this study is to determine the effect of the developed program on screen usage time and physical activity for pre-school children.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
The Screen-to-Move Program (STEP), developed on the basis of Social Cognitive Theory (SCT), aimed to reduce screen time and increase physical activity in preschool children in line with the WHO 24-hour movement guidelines. In this study, a 5-session, nurse-led intervention program based on SCT, involving children and their parents, was implemented. The effectiveness of the program was evaluated at pre-test, post-test and 3-month follow-up.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
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Istanbul, Турция (Туркие)
- Marmara University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Children aged 36-60 months and their parents.
- Children without any physical and mantel disability
Exclusion Criteria:
1.The data of parents who fill in the data collection forms incompletely will be excluded from the analysis
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Intervention Group
Originally planned as 6 weekly sessions; before the intervention started, the content was consolidated into 5 weekly sessions at the request of school administrators and parents. All topics planned for the 6 sessions were delivered in the 5 sessions; no content was removed. The Screen-to-Move Program (STEP) is a nurse-led program based on Social Cognitive Theory. Children received one 30-40 minute classroom session per week for 5 weeks, including stories, pictures, video demonstrations, interactive education and active play, with goal cards, achievement stickers and reinforcement. Parents received 5 concurrent online interactive sessions (about 45 minutes, each repeated 3 times) and weekly information notes. Children's screen time, step count and sleep duration, and parents' knowledge, attitudes, self-efficacy, screen use during child activities, screen time, physical activity and sleep were assessed at baseline, post-intervention and 3-month follow-up. |
A nurse-led program based on Social Cognitive Theory, delivered in 5 sessions, 1 session per week for children and parents. The program was introduced to children and parents as the "Screen-to-Move Program (STEP)". |
|
Без вмешательства: Control Group
Screen use time, daily physical activity time, sleep time, parents' knowledge, behavior, attitude and self-efficacy about children's screen use time will be evaluated simultaneously from the control group with the intervention group. After the 3rd month follow-up test, the STEP will be applied to the children and parents in the control group. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Decreasing screen time of children in the experimental group
Временное ограничение: Change in screen usage time within 3 months
|
Children's screen usage time will be evaluated with questions. "How long (…hours…..minutes) on average did your child use any device with an electronic screen, such as a smartphone, tablet, video game, or watch television, movies, video games in a day?". Daily screen usage time will be evaluated in minutes. A maximum of 60 minutes of screen time is recommended for pre-school children (World Health Organization, 2019). |
Change in screen usage time within 3 months
|
|
Increasing physical activity level of children in the experimental group
Временное ограничение: Change in physical activity level within 3 months
|
Children's physical activity levels; Item 1: "How long is your child active on average in a day? (e.g. walking slowly, making the bed etc.)" and Item 2:"How long does your child do physical activity in a day, on average, until he is out of breath?" (walking fast, cycling, running, playing ball games, swimming, dancing, etc.) will be evaluated based on parent self-report. The total daily (Item1 + Item2) physical activity time will be evaluated in minutes. A minimum of 180 minutes of physical activity is recommended for pre-school children (World Health Organization, 2019). |
Change in physical activity level within 3 months
|
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Increasing number of steps for the children in the experimental group
Временное ограничение: Change in number of steps within 3 months
|
Pre-school children's daily step count will be measured with the OMRON HJ-109-E pedometer. In our study, the number of steps for children aged 3-5 will be evaluated as 11,500 steps, which is stated to correspond to the 180 minutes physical activity target recommended by the World Health Organization for children aged 3-5 (De Craemer et al., 2015; World Health Organization, 2019). |
Change in number of steps within 3 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Increasing knowledge score of parents in the experimental group
Временное ограничение: Change in knowledge score of parents within 3 months
|
The information form was created by researchers in line with the literature (World Health Organization, 2019). The form contains information about the PA, screen usage time and sleep duration of the children of parents who have children between the ages of 2-5 and consists of 14 questions. For each item, the correct option is scored as 1, and the incorrect and I don't know option is scored as 0. The total score obtained by collecting the items varies between 0-14 points. A high score indicates a high level of knowledge. |
Change in knowledge score of parents within 3 months
|
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Increase in the attitude score of the parents in the experimental group
Временное ограничение: Change in parents' attitudes within 3 months
|
Parents' attitudes towards their children's screen time were evaluated with an eight-item questionnaire developed by Zimmerman et al. in 2007. The questionnaire is in a five-point Likert type, ranging from strongly agree (1) to strongly disagree (5). High scores on the survey reflect more positive attitudes. The questionnaire has been used in many studies before and has a high reliability with the cronbach alpha value of .84 (Carson & Janssen, 2012; Mansor et al., 2021; Raj et al., 2022). |
Change in parents' attitudes within 3 months
|
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Increasing self-efficacy score of parents in the experimental group
Временное ограничение: Change in self-efficacy score of parents within 3 months
|
Self-efficacy will be measured separately to reduce screen time and increase physical activity. Parents' self-efficacy in reducing their children's screen time: "How confident are you that you can say no to your child's request to participate in screen time (TV/computer/tablet/video games)?" It will be assessed on a 5-point scale ranging from 'not at all sure' to 'very sure' (Carson & Janssen, 2012). The parent's self-efficacy in influencing the child's physical activity reflects the parent's level of confidence in situations related to the child's physical activity. The questionnaire developed in 2010 has a single factor structure and high reliability (α= 0.88). The eight-question survey (For example: How confident are you that your child will do physical activity even if you do not have much time) is a five-point Likert type ranging from I do not trust myself (1) to I am very confident (5). High scores on the questionnaire reflect higher self-efficacy (Smith et al., 2010). |
Change in self-efficacy score of parents within 3 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Child sleep duration
Временное ограничение: Change in child sleep duration within 3 months
|
Parent-reported nighttime sleep duration of the child, calculated separately for weekdays and weekends from reported bedtime and wake-up time (hours/day). |
Change in child sleep duration within 3 months
|
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Proportion of children meeting the WHO 24-hour movement guidelines
Временное ограничение: Change in the proportion of children meeting the 24-hour movement guidelines within 3 months
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Percentage of children meeting each guideline individually and all three combined, based on the WHO guidelines for children under 5: physical activity (≥11,500 steps/day by pedometer), screen time (≤60 minutes/day, parent-reported) and sleep duration (10-13 hours/night, parent-reported). |
Change in the proportion of children meeting the 24-hour movement guidelines within 3 months
|
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Parental screen use during child activities
Временное ограничение: Change in PSU-CAS score of parents within 3 months
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Assessed with the Parental Screen Use During Child Activities Scale (PSU-CAS; 8 items, 5-point Likert). Total score ranges from 8 to 40; higher scores indicate more frequent parental screen use during child activities. |
Change in PSU-CAS score of parents within 3 months
|
|
Parental physical activity
Временное ограничение: Change in physical activity time of parents within 3 months
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Parent self-reported average daily physical activity time on weekdays and weekends (minutes/day). |
Change in physical activity time of parents within 3 months
|
|
Parental screen time
Временное ограничение: Change in screen time of parents within 3 months
|
Parent self-reported average daily non-work screen time (phone, tablet, computer, TV) on weekdays and weekends (minutes/day). |
Change in screen time of parents within 3 months
|
|
Parental sleep duration
Временное ограничение: Change in sleep duration of parents within 3 months
|
Parent self-reported nighttime sleep duration, calculated from reported bedtime and wake-up time (hours/day). |
Change in sleep duration of parents within 3 months
|
Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Ayse Ergun, Prof, Marmara University
- Главный следователь: Tuba Bay Kula, MSc, RN, Marmara University
Публикации и полезные ссылки
Общие публикации
- Carson V, Janssen I. Associations between factors within the home setting and screen time among children aged 0-5 years: a cross-sectional study. BMC Public Health. 2012 Jul 23;12:539. doi: 10.1186/1471-2458-12-539.
- De Craemer M, De Decker E, De Bourdeaudhuij I, Verloigne M, Manios Y, Cardon G. The translation of preschoolers' physical activity guidelines into a daily step count target. J Sports Sci. 2015;33(10):1051-7. doi: 10.1080/02640414.2014.981850. Epub 2014 Dec 18.
- Mansor E, Ahmad N, Raj D, Mohd Zulkefli NA, Mohd Shariff Z. Predictors of Parental Barriers to Reduce Excessive Child Screen Time Among Parents of Under-Five Children in Selangor, Malaysia: Cross-sectional Study. J Med Internet Res. 2021 Apr 13;23(4):e25219. doi: 10.2196/25219.
- Raj D, Mohd Zulkefli N, Mohd Shariff Z, Ahmad N. Determinants of Excessive Screen Time among Children under Five Years Old in Selangor, Malaysia: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Mar 17;19(6):3560. doi: 10.3390/ijerph19063560.
- Smith BJ, Grunseit A, Hardy LL, King L, Wolfenden L, Milat A. Parental influences on child physical activity and screen viewing time: a population based study. BMC Public Health. 2010 Oct 8;10:593. doi: 10.1186/1471-2458-10-593.
- Zimmerman FJ, Christakis DA, Meltzoff AN. Television and DVD/video viewing in children younger than 2 years. Arch Pediatr Adolesc Med. 2007 May;161(5):473-9. doi: 10.1001/archpedi.161.5.473.
- Guidelines on Physical Activity, Sedentary Behaviour and Sleep for Children under 5 Years of Age. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK541170/
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 19092293
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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