NCT04098913

Brief Summary

The purpose of this randomized controlled trial is to investigate the short-term efficacy of reducing recreational screen-based media use on physical activity patterns, sleep, physiological stress in families at least one child between 6-10 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 6, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

September 19, 2019

Last Update Submit

April 8, 2021

Conditions

Keywords

screen timephysical activitysleepstress

Outcome Measures

Primary Outcomes (1)

  • Between group change in leisure time spent being non-sedentary (children)

    Non-sedentary time is defined as any waking activity characterized as not being in a sitting, reclining or lying posture with minimal stationary movement. Activity is measured for 7 consecutive days at baseline and follow-up using combined trunk- and thigh worn accelerometry (Axivity AX3).

    14 days (experiment period)

Secondary Outcomes (15)

  • Between group change in leisure time spent being non-sedentary(adults)

    14 days (experiment period)

  • Between group change in leisure time moderate to vigorous physical activity (MVPA) (children)

    14 days (experiment period)

  • Between group change in leisure time moderate to vigorous physical activity MVPA (adults)

    14 days (experiment period)

  • Between group change in leisure time spent being non-sedentary on weekdays (children)

    14 days (experiment period)

  • Between group change in leisure time spent being non-sedentary on weekdays (adults)

    14 days (experiment period)

  • +10 more secondary outcomes

Other Outcomes (8)

  • Between group change in cortisol awakening response (adults)

    14 days (experiment period)

  • Between group change in diurnal cortisol slope (adults)

    14 days (experiment period)

  • Between group change in heart rate variability (HRV)

    14 days (experiment period)

  • +5 more other outcomes

Study Arms (2)

Reduced screen-based media use

EXPERIMENTAL

Reducing recreational screen-based media use for a period of 2 weeks.

Behavioral: Reduced screen-based media use

Control group

NO INTERVENTION

Participants are asked to continue their habitual screen-based media use.

Interventions

Participants must remove all recreational screen-based media use beyond 3 hours/week. This includes all recreational screen-based media use inside and outside the household. As a tool to comply with the intervention the families will hand-over all portable screen-based media devices. In return, each participant who own a smartphone will receive a regular cell-phone which can only make phone calls and send text messages. For a maximum of ½ an hour a day, adult participants may use screen-based media for necessary contact/errands. If one of the adult participants can not hand over their smartphones due to daily use for work purposes we will install an app tracking screen use on these devices.

Reduced screen-based media use

Eligibility Criteria

Age4 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • High amount of screen time according to self-report: In each household, at least one adult must be above the 40th percentile for self-reported screen-time during spare time based on what was reported in the survey ((characterized as high in this study).
  • To be eligible for the measurements children in the household must be ≥ 4 and \< 15 years old during the entire experiment period.
  • Adults must work full time or be full-time students
  • Adults and children who participates in the measurements must have the resources to remove all recreational- and work-/school-related screen-time in the late afternoon and evening hours and during weekend days, with a few exceptions (described in the "intervention" section below), for a period of 2 weeks (intervention length).
  • The household must include at least one adult and one child 6-10 years of age at the time the survey was sent out, both of whom must consent to participate in the experiment.
  • Participants must report that they consider the extent of their screen time an issue
  • Participants must report to be particularly motivated to decrease screen-time for the whole family household.
  • Members of the household who choose not to participate or who is ineligible to participate in the measurements or the intervention, must be willing to support the remainder of the household in making the experiment a success for them.

You may not qualify if:

  • If the adults or children only reside in the household part time, e.g. have multiple addresses
  • Prescribed a period of sick leave due to stress within the last 3 months.
  • Diagnosis of sleep disorders from their general practitioner still interfering sleep
  • Working night shifts
  • In any shape or form limited in one's ability to engage in physical activities
  • Neuro psychiatric disorders, such as attention deficit hyperactivity disorder (ADHD) and autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Funen, 5230, Denmark

Location

Related Publications (4)

  • Schmidt-Persson J, Rasmussen MGB, Sorensen SO, Mortensen SR, Olesen LG, Brage S, Kristensen PL, Bilenberg N, Grontved A. Screen Media Use and Mental Health of Children and Adolescents: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419881. doi: 10.1001/jamanetworkopen.2024.19881.

  • Pedersen J, Rasmussen MGB, Sorensen SO, Mortensen SR, Olesen LG, Brage S, Kristensen PL, Puterman E, Grontved A. Effects of limiting digital screen use on well-being, mood, and biomarkers of stress in adults. Npj Ment Health Res. 2022;1(1):14. doi: 10.1038/s44184-022-00015-6. Epub 2022 Oct 12.

  • Pedersen J, Rasmussen MGB, Sorensen SO, Mortensen SR, Olesen LG, Brond JC, Brage S, Kristensen PL, Grontved A. Effects of Limiting Recreational Screen Media Use on Physical Activity and Sleep in Families With Children: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Aug 1;176(8):741-749. doi: 10.1001/jamapediatrics.2022.1519.

  • Rasmussen MGB, Pedersen J, Olesen LG, Brage S, Klakk H, Kristensen PL, Brond JC, Grontved A. Short-term efficacy of reducing screen media use on physical activity, sleep, and physiological stress in families with children aged 4-14: study protocol for the SCREENS randomized controlled trial. BMC Public Health. 2020 Mar 23;20(1):380. doi: 10.1186/s12889-020-8458-6.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anders Grøntved, Ph.D.

    University of Southern Denamrk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

June 6, 2019

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations