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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04395287
Other study ID # S-2015-0178
Secondary ID 2015-57-0008
Status Completed
Phase
First received
Last updated
Start date May 4, 2020
Est. completion date July 8, 2021

Study information

Verified date July 2021
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. - 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 887
Est. completion date July 8, 2021
Est. primary completion date July 8, 2021
Accepts healthy volunteers
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion: - All children who at the time of recruitment attended public preschools in the Municipality of Svendborg Exclusion: - None

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Denmark Research in Childhood Health Research Center Odense Southern Danmark

Sponsors (3)

Lead Sponsor Collaborator
University of Southern Denmark European Research Council, University of Sydney

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Non-sedentary time during leisure Change in mean min/day 18 months
Secondary Time spent lying down during leisure Change in mean min/day 18 months
Secondary Time spent sitting during leisure Change in mean min/day 18 months
Secondary Time spent 'moving' during leisure Change in mean min/day of standing activity with a small degree of bodily movement 18 months
Secondary Time spent standing during leisure Change in mean min/day 18 months
Secondary Time spent walking during leisure Change in mean min/day 18 months
Secondary Time spent running during leisure Change in mean min/day 18 months
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