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Reduction of Screen-Based Media Use in Families With Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788525
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
European Research Council
Information provided by (Responsible Party):
University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 27, 2018
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Compliance to prescribed intervention (objective assessment) [ Time Frame: 14 days (experiment period) ]
    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.
  • Compliance to prescribed intervention (subjective assessment) [ Time Frame: 14 days (experiment period) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2018)
Compliance to prescribed intervention (combination of objective and subjective methods) [ Time Frame: 14 days (experiment period) ]
Proportion of participants who are compliant to the prescribed intervention according to a combination of the objective and subjective compliance assessments. 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. 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2018)
  • Compliance to objective physical activity measurement [ Time Frame: 14 days (experiment period) ]
    Proportion of participants wearing the accelerometer belts (Axivity AX3) for at least four out of seven measurements days at baseline and follow-up (at least one day must be a weekend day).
  • Compliance to sleep measurement [ Time Frame: 14 days (experiment period) ]
    Proportion of participants wearing the sleep equipment (Zmachine Insight+) for at least two out of three measurement nights at baseline and follow-up.
  • Compliance to heart rate variability measurement [ Time Frame: 14 days (experiment period) ]
    Proportion of participants wearing the heart rate variability device (Firstbeat Bodyguard 2) for at least two out of three measurement days at baseline and follow-up.
  • Compliance to saliva sampling protocol (only in adults) [ Time Frame: 14 days (experiment period) ]
    Proportion of participants delivering salivary samples from two out of three measurement days which is equivalent to eight out of twelve samples at baseline and follow-up. Samples are collected by the participant at awakening, 30 min. after awakening, 45 min. after awakening, and just before bedtime.
  • Feasibility of the recruitment strategy [ Time Frame: Up to four months ]
    Proportion of invited participants completing the full experiment period. Participants are invited and recruited continuously throughout the study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Screen-Based Media Use in Families With Children
Official Title  ICMJE Reduction of Screen-Based Media Use in Families With Children: a Randomized Pilot Trial
Brief Summary

The purpose of this pilot experiment is threefold.

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

Modern day's excessive use of screen-based media is heavily discussed in the public in terms of its possible harmful effects on physical and mental health among children and adults. To date there is little rigorously conducted research available on the effects of high use of todays screen-based media. Of particular notice, no controlled experimental studies in free-living have been carried out to study the immediate effects of screen-based media use on habitual physical activity patterns, sleep, and temporary stress- and emotional state.

To undertake a large-scale randomized controlled trial of the efficacy of limiting screen-based media use in families of parents and children the investigators aim to conduct a pilot study to assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes and the acceptability of the prescribed interventions to reduce screen media use. The investigators also perform the pilot study to investigate the efficacy of our recruitment strategy.

The participating families (households with children ≥4 and <18 years old) will be invited to answer a recruitment questionnaire sent out to their personal digital mailbox, which is a compulsory digital solution to receive mail from i.e. public authorities. Based on the survey answers eligible families (see section on inclusion/exclusion criteria) will be invited to participate in this pilot experiment. Families who are willing to participate will be randomized to one of two intervention groups after completion of the baseline measurement protocol. One group must reduce all recreational screen-based media use to less than three hours per week for a period of two weeks. Participants in this group will be asked to hand over their portable screen devices and in exchange they will be handed an old model Nokia phone. The other group must remove all screen-based media use (both work-related and recreational) after 6PM for a period of two weeks. The experiment does not include a control group. To ensure compliance to the interventions, the investigators will install an app, which will measure screen use on each participant's smartphone(s) and tablet(s). Furthermore, the investigators will connect a device to all televisions in each household, which will monitor television usage. To investigate the effect of the interventions all participants will go through a 7-day measurement protocol just before the family is randomized to one of the interventions and again during the last week of the intervention period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Feasibility Studies
Intervention  ICMJE
  • Behavioral: Reduced recreational screen time
    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.
  • Behavioral: Timed recreational screen time
    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.
Study Arms  ICMJE
  • Experimental: Reduced recreational screen time
    Reducing recreational screen-based media use for a period of 2 weeks
    Intervention: Behavioral: Reduced recreational screen time
  • Experimental: Timed recreational screen time
    Reduced and timed recreational screen-based media use for a period of 2 weeks
    Intervention: Behavioral: Timed recreational screen time
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2018)
20
Actual Study Completion Date  ICMJE March 20, 2019
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03788525
Other Study ID Numbers  ICMJE S-20170213
716657 ( Other Grant/Funding Number: European Research Council )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE European Research Council
Investigators  ICMJE
Principal Investigator: Anders Grøntved, Ph.D. University of Southern Denamrk
PRS Account University of Southern Denmark
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP