Prospective Associations Between Screen Media Use and Physical Activity in Preschool Children

• Sponsor: University of Southern Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT04395287
• Collaborator: European Research Council (Other), University of Sydney (Other)
• Enrollment: 887
• Location: 1
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 62.8

Study Details

Study Description

Brief 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.

• 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.

Condition or Disease	Intervention/Treatment	Phase
Screen Time	Behavioral: Leisure screen time

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

• Study Type: Observational
• Actual Enrollment: 887 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Associations Between Screen Media Use and Physical Activity in Preschool Children: Findings From the Motor Skills in PreSchool (MIPS) Study
• Actual Study Start Date: May 4, 2020
• Actual Primary Completion Date: Jul 8, 2021
• Actual Study Completion Date: Jul 8, 2021

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. Non-sedentary time during leisure [18 months]

   Change in mean min/day

Secondary Outcome Measures

1. Time spent lying down during leisure [18 months]

   Change in mean min/day

2. Time spent sitting during leisure [18 months]

   Change in mean min/day

3. Time spent 'moving' during leisure [18 months]

   Change in mean min/day of standing activity with a small degree of bodily movement

4. Time spent standing during leisure [18 months]

   Change in mean min/day

5. Time spent walking during leisure [18 months]

   Change in mean min/day

6. Time spent running during leisure [18 months]

   Change in mean min/day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All

Inclusion:

• All children who at the time of recruitment attended public preschools in the Municipality of Svendborg

Exclusion:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research in Childhood Health Research Center	Odense	Southern Danmark	Denmark	5230

Sponsors and Collaborators

• University of Southern Denmark
• European Research Council
• University of Sydney

Investigators

• Principal Investigator: Line G. Olesen, Ph.D., University of Southern Denmark

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 28, 2020

More Information

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.

• Responsible Party: University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT04395287
• Other Study ID Numbers: S-2015-0178; 2015-57-0008
• First Posted: May 20, 2020
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 12, 2021