Screen TimeNCT04395287
Prospective Associations Between Screen Media Use and Physical Activity in Preschool Children
An observational study of Screen Time, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aims of this study are as follows: The primary aim is to investigate the relationship between changes in screen media use with changes in non-sedentary time (time, min/day, spent in activities other than lying and sitting) during leisure (outside nursery) from baseline to 18-month follow-up. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Screen Time
- What is being tested?
- Leisure screen time
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 887 participants
- Where
- 1 siteDenmark
- Study dates
- 4 May 2020to 8 Jul 2021
- Phase
- Observational
- 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 3 to 6 years
- All sexes
- Child
Study population: 3-6-year-old children attending public preschools in Municipality of Svendborg at the time of recruitment (fall of 2016), and their parents
Who may be able to join
- All children who at the time of recruitment attended public preschools in the Municipality of Svendborg
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research in Childhood Health Research Center
Odense, Southern Danmark, 5230
About this study
Official title: Prospective Associations Between Screen Media Use and Physical Activity in Preschool Children: Findings From the Motor Skills in PreSchool (MIPS) Study
The aims of this study are as follows:
- The primary aim is to investigate the relationship between changes in screen media use with changes in non-sedentary time (time, min/day, spent in activities other than lying and sitting) during leisure (outside nursery) from baseline to 18-month follow-up.
- The secondary aim is to investigate the relationship between changes in screen media use and time (min/day) spent in specific daily activities (lying, sitting, moving, standing, walking, and running) and changes in moderate-to-vigorous intensity physical activity during leisure.
Read the detailed description
The current study is a secondary, observational investigation of data from The Motor Skills in PreSchool (MIPS) study. The MIPS study was initiated in 2016 and included preschool children (3-6 years of age) attending public preschools in the Municipality of Svendborg, in Denmark. A subset of the preschools included an intervention component, whose aim was optimization of motor skills. In this study, the children's screen media use was assessed via questionnaire and physical activity was assessed using two Axivity AX3 (Axivity Ltd., Newcastle upon Tyne, United Kingdom) triaxial accelerometers - one placed at the hip and one at the lower back - at both baseline and at 18-month follow-up. Time spent in distinct activity types (sitting, moving, standing, biking, running, walking, and lying down) are determined from the acceleration measured with the thigh worn device. In addition, data on relevant covariates was also collected. Having data on both exposure and outcome at baseline and follow-up renders detailed longitudinal assessments possible. Furthermore, daily schedule (proxy based on reporting by parents and pedagogical personnel) information on the children introduces the possibility of domain-specific analyses of physical activity, as we can time annotate the data into different sections of the children's daily routine.
- Conditions
- Screen Time
- Being tested
- Leisure screen time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leisure screen timeBehavioural
Questionnaire-based assessment of typical amount of time per week spent using screen-based media devices during leisure, assessed at two time points. Continuously scaled in main analyses; a difference is computed (18-month follow-up value minus baseline value). Additionally, screen time amount at the two time points will be scaled categorically, according to being classified as low or high according to WHO criteria for preschool children (Low (recommended): <=1 hour/day, high: >1 hour/day): High-high, high-low, low-high, and low-low.
| Study group | Role | What they receive |
|---|---|---|
| Preschool children | Attending public preschools in Svendborg, Denmark, at the time of recruitment Receives: Behavioral: Leisure screen time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-sedentary time during leisure
Change in mean min/day
Measured: 18 months
Secondary outcomes (6)
Time spent lying down during leisure
Change in mean min/day
Measured: 18 months
Time spent sitting during leisure
Change in mean min/day
Measured: 18 months
Time spent 'moving' during leisure
Change in mean min/day of standing activity with a small degree of bodily movement
Measured: 18 months
Time spent standing during leisure
Change in mean min/day
Measured: 18 months
Time spent walking during leisure
Change in mean min/day
Measured: 18 months
Time spent running during leisure
Change in mean min/day
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start4 May 2020
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Screen TimeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council, University of Sydney
- Responsible party
- Sponsor
- Investigators
- Line G. Olesen, Ph.D., Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395287
- Sponsor's protocol ID
- S-2015-0178
- Other IDs
- 2015-57-0008
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2020
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hestbaek L, Andersen ST, Skovgaard T, Olesen LG, Elmose M, Bleses D, Andersen SC, Lauridsen HH. Influence of motor skills training on children's development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study. Trials. 2017 Aug 29;18(1):400. doi: 10.1186/s13063-017-2143-9.
PubMed 28851412
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Associations Between Screen Media Use and Physical Activity in Preschool Children: Findings From the Motor Skills in PreSchool (MIPS) Study
- ClinicalTrials.gov ID
- NCT04395287
- Acronym / sponsor ID
- S-2015-0178
- Conditions
- Screen Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- European Research Council, University of Sydney
- Study start
- 4 May 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 20 May 2020 (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 aims of this study are as follows:
- The primary aim is to investigate the relationship between changes in screen media use with changes in non-sedentary time (time, min/day, spent in activities other than lying and sitting) during leisure (outside nursery) from baseline to 18-month follow-up.
- The secondary aim is to investigate the relationship between changes in screen media use and time (min/day) spent in specific daily activities (lying, sitting, moving, standing, walking, and running) and changes in moderate-to-vigorous intensity physical activity during leisure.
Detailed description
The current study is a secondary, observational investigation of data from The Motor Skills in PreSchool (MIPS) study. The MIPS study was initiated in 2016 and included preschool children (3-6 years of age) attending public preschools in the Municipality of Svendborg, in Denmark. A subset of the preschools included an intervention component, whose aim was optimization of motor skills. In this study, the children's screen media use was assessed via questionnaire and physical activity was assessed using two Axivity AX3 (Axivity Ltd., Newcastle upon Tyne, United Kingdom) triaxial accelerometers - one placed at the hip and one at the lower back - at both baseline and at 18-month follow-up. Time spent in distinct activity types (sitting, moving, standing, biking, running, walking, and lying down) are determined from the acceleration measured with the thigh worn device. In addition, data on relevant covariates was also collected. Having data on both exposure and outcome at baseline and follow-up renders detailed longitudinal assessments possible. Furthermore, daily schedule (proxy based on reporting by parents and pedagogical personnel) information on the children introduces the possibility of domain-specific analyses of physical activity, as we can time annotate the data into different sections of the children's daily routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preschool children | – | Behavioral: Leisure screen timeAttending public preschools in Svendborg, Denmark, at the time of recruitment |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- 3-6-year-old children attending public preschools in Municipality of Svendborg at the time of recruitment (fall of 2016), and their parents
Key inclusion criteria (1 listed)
- All children who at the time of recruitment attended public preschools in the Municipality of Svendborg
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Leisure screen timeQuestionnaire-based assessment of typical amount of time per week spent using screen-based media devices during leisure, assessed at two time points. Continuously scaled in main analyses; a difference is computed (18-month follow-up value minus baseline value). Additionally, screen time amount at the two time points will be scaled categorically, according to being classified as low or high according to WHO criteria for preschool children (Low (recommended): <=1 hour/day, high: >1 hour/day): High-high, high-low, low-high, and low-low. | Behavioural | Preschool children |
Primary outcome
Non-sedentary time during leisure
Time frame: 18 months
Change in mean min/day
6 secondary outcomes
Time spent lying down during leisure
Time frame: 18 months
Time spent sitting during leisure
Time frame: 18 months
Time spent 'moving' during leisure
Time frame: 18 months
Time spent standing during leisure
Time frame: 18 months
Time spent walking during leisure
Time frame: 18 months
Time spent running during leisure
Time frame: 18 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 12 Jul 2021.
- Background: PubMed 28851412Hestbaek L, Andersen ST, Skovgaard T, Olesen LG, Elmose M, Bleses D, Andersen SC, Lauridsen HH. Influence of motor skills training on children's development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study. Trials. 2017 Aug 29;18(1):400. doi: 10.1186/s13063-017-2143-9.
- Individual participant dataSharing planned: Undecided
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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.
Line G. Olesen, Ph.D. principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screen Time, run by University of Southern Denmark at 1 site in Denmark.
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 1 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 12 Jul 2021. 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 Denmark. 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?
Non-sedentary time during leisure (time frame: 18 months). 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 NCT04395287, which also lists 1 linked publication.
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 12 Jul 2021.