NCT03788525

Brief Summary

The purpose of this pilot experiment is threefold.

  1. 1.To assess the efficacy of the recruitment strategy
  2. 2.To assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes
  3. 3.To assess the acceptability of the prescribed interventions to reduce screen media use

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 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

November 12, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

December 20, 2018

Last Update Submit

May 17, 2022

Conditions

Feasibility Studies

Keywords

Screen time

Outcome Measures

Primary Outcomes (2)

  • Compliance to prescribed intervention (objective assessment)

    Proportion of participants who are compliant to the prescribed intervention. Compliance is assessed objectively using data from the Device Tracker App (installed on all portable devices) and the television monitor installed on all televisions in the household.

    14 days (experiment period)

  • Compliance to prescribed intervention (subjective assessment)

    Proportion of participants who are compliant to the prescribed intervention. Compliance is assessed subjectively through a daily screen-media dairy. All participants are required to hold the daily screen-media dairy throughout the experiment period.

    14 days (experiment period)

Secondary Outcomes (5)

  • Compliance to objective physical activity measurement

    14 days (experiment period)

  • Compliance to sleep measurement

    14 days (experiment period)

  • Compliance to heart rate variability measurement

    14 days (experiment period)

  • Compliance to saliva sampling protocol (only in adults)

    14 days (experiment period)

  • Feasibility of the recruitment strategy

    Up to four months

Study Arms (2)

Reduced recreational screen time

EXPERIMENTAL

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

Behavioral: Reduced recreational screen time

Timed recreational screen time

EXPERIMENTAL

Reduced and timed recreational screen-based media use for a period of 2 weeks

Behavioral: Timed recreational screen time

Interventions

Reduced recreational screen timeBEHAVIORAL

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 this device for necessary contact. The families are allowed a maximum of 3 hours/week of recreational screen time. If 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 recreational screen time
Timed recreational screen timeBEHAVIORAL

Participants must remove all recreational screen-based media use after 6 PM. There are no restrictions on the amount of screen-based media use before 6 PM. Thus, before 6 PM, the participants must continue their habitual screen-based media use completely. However, after 6 PM, both work-related and recreational screen-based media use must be removed completely.

Timed recreational screen time

Eligibility Criteria

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

You may qualify if:

  • High amount of screen-based media according to self-report (based on the adults only)
  • In each household, at least one adult and one child must be above the 50th percentile for self-reported screen-based media use (characterized as "high" in this study). The 50th percentile is based on the responses from all adults who answered the recruitment survey.
  • The children in the household are ≥ 4 and ≤ 18 years old, at the time the survey is sent out. In this way sleep measurements do not get distorted by infants and toddlers in the household (e.g. sleep).
  • Adults and children who participate in the measurements must have the resources to remove all recreational- and work-/school-related screen-time in the evening hours, with a few exceptions, for a period of 2 weeks (intervention length).
  • Participants must report that they consider the extent of their screen-based media use an issue
  • Participants must report to be motivated to decrease screen-based media use for the whole family household.
  • Family members who choose to not participate or are ineligible must be willing to support the success of this family experiment.

You may not qualify if:

  • If the adults or children only reside in the household part time, i.e. have multiple addresses
  • Diagnosis of stress from their general practitioner within the last year
  • Diagnosis of sleep disorders from their general practitioner within the last year
  • Working night shifts
  • In any shape or form limited in one's ability to participate in habitual physical activity
  • Has or is in inquiry of Neuropsychiatric disorders, such as Attention Deficit Hyperactivity Disorder (ADHD) or development disorders such as Autism.
  • Already participating in research studies, such as the Odense Child Cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Funen, 5230, Denmark

Location

Related Publications (3)

  • Rasmussen MGB, Pedersen J, Olesen LG, Kristensen PL, Brond JC, Grontved A. Feasibility of two screen media reduction interventions: Results from the SCREENS pilot trial. PLoS One. 2021 Nov 15;16(11):e0259657. doi: 10.1371/journal.pone.0259657. eCollection 2021.

    PMID: 34780511RESULT

  • Sorensen SO, Pedersen J, Rasmussen MG, Kristensen PL, Grontved A. Feasibility of home-based sampling of salivary cortisol and cortisone in healthy adults. BMC Res Notes. 2021 Nov 2;14(1):406. doi: 10.1186/s13104-021-05820-4.

    PMID: 34727972RESULT

  • Pedersen J, Rasmussen M G B, Olesen L G, Kristensen P L, Grøntved A. Self-administered electroencephalography-based sleep assessment: compliance and perceived feasibility in children and adults. Sleep Science and Practice. 2021; 5(1):8. doi.org/10.1186/s41606-021-00059-1

    RESULT

Related Links

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
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 27, 2018

Study Start

November 12, 2018

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

DK(1)