NCT04395287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
887

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

April 28, 2020

Last Update Submit

July 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non-sedentary time during leisure

    Change in mean min/day

    18 months

Secondary Outcomes (6)

  • Time spent lying down during leisure

    18 months

  • Time spent sitting during leisure

    18 months

  • Time spent 'moving' during leisure

    18 months

  • Time spent standing during leisure

    18 months

  • Time spent walking during leisure

    18 months

  • +1 more secondary outcomes

Study Arms (1)

Preschool children

Attending public preschools in Svendborg, Denmark, at the time of recruitment

Behavioral: Leisure screen time

Interventions

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.

Preschool children

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research in Childhood Health Research Center

Odense, Southern Danmark, 5230, Denmark

Location

Related 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.

    PMID: 28851412BACKGROUND

Study Officials

  • Line G. Olesen, Ph.D.

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 20, 2020

Study Start

May 4, 2020

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Locations