- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04395287
Prospective Associations Between Screen Media Use and Physical Activity in Preschool Children
July 9, 2021 updated by: University of Southern Denmark
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
887
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Southern Danmark
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Odense, Southern Danmark, Denmark, 5230
- Research in Childhood Health Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion:
- All children who at the time of recruitment attended public preschools in the Municipality of Svendborg
Exclusion:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Preschool children
Attending public preschools in Svendborg, Denmark, at the time of recruitment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-sedentary time during leisure
Time Frame: 18 months
|
Change in mean min/day
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time spent lying down during leisure
Time Frame: 18 months
|
Change in mean min/day
|
18 months
|
|
Time spent sitting during leisure
Time Frame: 18 months
|
Change in mean min/day
|
18 months
|
|
Time spent 'moving' during leisure
Time Frame: 18 months
|
Change in mean min/day of standing activity with a small degree of bodily movement
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18 months
|
|
Time spent standing during leisure
Time Frame: 18 months
|
Change in mean min/day
|
18 months
|
|
Time spent walking during leisure
Time Frame: 18 months
|
Change in mean min/day
|
18 months
|
|
Time spent running during leisure
Time Frame: 18 months
|
Change in mean min/day
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Line G. Olesen, Ph.D., University of Southern Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2020
Primary Completion (Actual)
July 8, 2021
Study Completion (Actual)
July 8, 2021
Study Registration Dates
First Submitted
April 28, 2020
First Submitted That Met QC Criteria
May 14, 2020
First Posted (Actual)
May 20, 2020
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 9, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- S-2015-0178
- 2015-57-0008 (Other Identifier: Danish Data Protection Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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