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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05805592
Other study ID # 19092293
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date July 2024

Study information

Verified date March 2024
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The "Screen-to-Move-Program" (STEP), developed on the basis of Social Cognitive Theory (SCT), is aimed to reduce screen usage time and increase physical activity in pre-school children. In this study, it was aimed to increase children's physical activity and decrease screen usage times with a 6 session intervention program based on SCT, which includes children and parents. The effectiveness of the program will be evaluated with the pre-test, post-test and 3rd month follow-up test.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 188
Est. completion date July 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Months to 60 Months
Eligibility Inclusion Criteria: 1. Children aged 36-60 months and their parents. 2. 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Screen-to-Move-Program (STEP)
It is planned as 6 sessions, 1 session per week for children and parents. The program will be introduced to children and parents under the call with "Screen-to-Move-Program (STEP)".

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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 De — View Citation

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/ — View Citation

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):e252 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Decreasing screen time of children in the experimental group 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
Primary Increasing physical activity level of children in the experimental group 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
Primary Increasing number of steps for the children in the experimental group 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
Secondary Increasing knowledge score of parents in the experimental group 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
Secondary Increase in the attitude score of the parents in the experimental group 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
Secondary Increasing self-efficacy score of parents in the experimental group 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 (a= 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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