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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Denmark
    • Southern Danmark
      • Odense, Southern Danmark, Denmark, 5230
        • Research in Childhood Health Research Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Preschool children
Attending public preschools in Svendborg, Denmark, at the time of recruitment
Behavioral: Leisure screen time
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sydney
European Research Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings