Physical ActivityNCT05805592
The Effect of Screen to Move Program in Preschool Children
A study testing Screen-to-Move-Program (STEP) in people with Physical Activity and Screen Time, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 36 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Screen Time, Child, Preschool
- What is being tested?
- Screen-to-Move-Program (STEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 36-60 months and their parents.
- Children without any physical and mantel disability
Who cannot join
- 1.The data of parents who fill in the data collection forms incompletely will be excluded from the analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Screen to Move Program (STEP) on Screen Use Time and Physical Activity in Preschool Children
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.
Read the detailed description
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.
- Conditions
- Physical Activity, Screen Time, Child, Preschool
- Being tested
- Screen-to-Move-Program (STEP)
- Keywords
- Physical Activity, Screen time, Pre-school child
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen-to-Move-Program (STEP)Behavioural
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)".
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Change in number of steps within 3 months
Secondary outcomes (3)
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.
Measured: Change in knowledge score of parents within 3 months
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).
Measured: Change in parents' attitudes within 3 months
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 (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).
Measured: Change in self-efficacy score of parents within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Nov 2023
- Primary completion12 Jun 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel group randomized controlled study.
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Bay Kula, Marmara University
- Investigators
- Ayse Ergun, Prof, Study chair, Marmara UniversityTuba Bay Kula, MSc, RN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805592
- Sponsor's protocol ID
- 19092293
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22823887De 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.
PubMed 25524541Mansor 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.
PubMed 33847590Raj 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.
PubMed 35329247Smith 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.
PubMed 20929587Zimmerman 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.
PubMed 17485624Guidelines 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/
PubMed 31091057
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Screen to Move Program (STEP) on Screen Use Time and Physical Activity in Preschool Children
- ClinicalTrials.gov ID
- NCT05805592
- Acronym / sponsor ID
- 19092293
- Conditions
- Physical Activity, Screen Time, Child, Preschool
- Keywords
- Physical Activity, Screen time, Pre-school child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Screen-to-Move-Program (STEP)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. |
| 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. |
Who may qualify
- Ages
- 36 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 36-60 months and their parents.
- Children without any physical and mantel disability
Key exclusion criteria (1 listed)
- 1.The data of parents who fill in the data collection forms incompletely will be excluded from the analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen-to-Move-Program (STEP)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)". | Behavioural | Intervention Group |
Primary outcome
Decreasing screen time of children in the experimental group
Time frame: 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).
Increasing physical activity level of children in the experimental group
Time frame: 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).
Increasing number of steps for the children in the experimental group
Time frame: 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).
3 secondary outcomes
Increasing knowledge score of parents in the experimental group
Time frame: Change in knowledge score of parents within 3 months
Increase in the attitude score of the parents in the experimental group
Time frame: Change in parents' attitudes within 3 months
Increasing self-efficacy score of parents in the experimental group
Time frame: Change in self-efficacy score of parents within 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 22823887Carson 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.
- Results publication: PubMed 25524541De 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.
- Results publication: PubMed 33847590Mansor 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.
- Results publication: PubMed 35329247Raj 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.
- Results publication: PubMed 20929587Smith 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.
- Results publication: PubMed 17485624Zimmerman 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.
- Results publication: PubMed 31091057Guidelines 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/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Ergun, Prof study chair
Marmara University
Tuba Bay Kula, MSc, RN principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen-to-Move-Program (STEP) in people with Physical Activity and Screen Time, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreasing screen time of children in the experimental group (time frame: Change in screen usage time within 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05805592, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.