NCT05805592

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 5, 2023

Last Update Submit

March 13, 2024

Conditions

Keywords

Physical ActivityScreen timePre-school child

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Increasing knowledge score of parents in the experimental group

    Change in knowledge score of parents within 3 months

  • Increase in the attitude score of the parents in the experimental group

    Change in parents' attitudes within 3 months

  • Increasing self-efficacy score of parents in the experimental group

    Change in self-efficacy score of parents within 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)". The symbol of the program has been created and this symbol will be hung on the classroom door. Sessions for children include story, picture, video demonstration and active playing activities. A more clear, simple and understandable language will be used for children, and reinforcements will be used. For parents; There will be 6 training sessions in the form of presentations. At the same time as the children's activities, information notes will be sent to the parents outlining the expectations. Before the intervention, after the intervention and in the 3rd month, children's screen use time, daily physical activity time, sleep time, parents' knowledge, behavior, attitude and self-efficacy about their children's screen use time will be evaluated.

Behavioral: Screen-to-Move-Program (STEP)

Control Group

NO INTERVENTION

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.

Interventions

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)".

Intervention Group

Eligibility Criteria

Age36 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 36-60 months and their parents.
  • Children without any physical and mantel disability

You may not qualify if:

  • The data of parents who fill in the data collection forms incompletely will be excluded from the analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related 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.

  • 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/

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ayse Ergun, Prof

    Marmara University

    STUDY CHAIR
  • Tuba Bay Kula, MSc, RN

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a parallel group randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2023

First Posted

April 10, 2023

Study Start

November 1, 2023

Primary Completion

March 1, 2024

Study Completion

July 1, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations