Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short-term Efficacy of Reducing Screen-based Media Use (SCREENS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098913
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
European Research Council
Information provided by (Responsible Party):
University of Southern Denmark

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.

Condition or disease Intervention/treatment Phase
Screen Time Behavioral: Reduced screen-based media use Not Applicable

Detailed Description:

Today screen-based media devices are almost unavoidable in our everyday lives. The media landscape has changed markedly during the past decade with some of the main aspects being the introduction of new portable devices, social networks, and online streaming services. The current experimental evidence on the efficacy of reducing todays screen-based media use in free-living is scarce.

This randomized controlled trial will be carried out based on the experience from a recently conducted pilot study, which was a 2-arm randomized non-controlled trial. The purposes of the pilot study were to explore the feasibility of our recruitment protocol, 7-day measurement protocol and the degree of compliance to the intervention components; namely a heavy restriction in recreational screen time for a 2-week period, either timed (no screen after 18 pm) or time restricted (≤ 3 hours/week/person).

In the current trial, only the time restricted protocol will be included, compared to a control group. To investigate the short-term efficacy of the intervention, the participants will go through a 7-day measurement protocol at baseline and again, during the final week of the intervention period (follow-up).

Ninety-five families with at least one child between 6-10 years of age will be recruited. A randomly selected adult from each household will be invited to answer a questionnaire, also including an invitation regarding participation in the current randomized controlled trial. Invitations will be sent to the adults' digital mailbox (e-boks), which is an online solution where one can receive mail from e.g. Danish public authorities. Based on the answers in the survey a preliminary screening for eligibility will be conducted (see section on inclusion/exclusion criteria). Families who fulfill specific criteria in the survey and further criteria assessed during a phone conversation will be invited to participate in this randomized controlled trial. Families who wish to participate will, after completion of the baseline protocol, will be randomized to either the intervention group or the control group (see section on arms and interventions).

The intervention (reducing recreational screen-based media use) was designed using the core major and minor elements of Albert Bandura's Social Cognitive Theory; namely, based on the idea of reciprocal determinism of an individual's environment, personal factors and behavior. The intervention includes i) a preparation document and meeting with the parents with the purpose of planning the course of the intervention and prepare the parents to set goals and self-regulate; ii) handing over the families portable screen devices when possible with an alternative mobile phone in exchange, which can be solely used for calls and text messages, will be afforded to the participants; iii) installing monitor software on all computers (stationary and laptops) and tablets and smartphone if these could not be given up, and connect a monitor device to all televisions in each household; iv) using "intervention reminders" (social cues), which will be placed beside stationary screen-based media devices and at central positions in the household such as the dining table.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Short Term Efficacy of Reducing Screen-based Media Use on Physical Activity, Sleep, and Physiological Stress and Well-Being in Families With Children - A Randomized Controlled Trial
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Experimental: Reduced screen-based media use
Reducing recreational screen-based media use for a period of 2 weeks.
Behavioral: Reduced screen-based media use
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.

No Intervention: Control group
Participants are asked to continue their habitual screen-based media use.



Primary Outcome Measures :
  1. Between group change in leisure time spent being non-sedentary (children) [ Time Frame: 14 days (experiment period) ]
    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).


Secondary Outcome Measures :
  1. Between group change in leisure time spent being non-sedentary(adults) [ Time Frame: 14 days (experiment period) ]
    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).

  2. Between group change in leisure time moderate to vigorous physical activity (MVPA) (children) [ Time Frame: 14 days (experiment period) ]
    Activity is measured for 7 consecutive days at baseline and follow-up using combined trunk- and thigh worn accelerometry (Axivity AX3).

  3. Between group change in leisure time moderate to vigorous physical activity MVPA (adults) [ Time Frame: 14 days (experiment period) ]
    Activity is measured for 7 consecutive days at baseline and follow-up using combined trunk- and thigh worn accelerometry (Axivity AX3).

  4. Between group change in leisure time spent being non-sedentary on weekdays (children) [ Time Frame: 14 days (experiment period) ]
    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).

  5. Between group change in leisure time spent being non-sedentary on weekdays (adults) [ Time Frame: 14 days (experiment period) ]
    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).

  6. Between group change in leisure time spent being non-sedentary on weekend days (children) [ Time Frame: 14 days (experiment period) ]
    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).

  7. Between group change in leisure time spent being non-sedentary on weekend days (adults) [ Time Frame: 14 days (experiment period) ]
    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).

  8. Between group change in total sleep duration (children) [ Time Frame: 14 days (experiment period) ]
    Total sleep duration is defined as time spent asleep within a sleep period, excluding wake time. Total sleep duration is measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+).

  9. Between group change in total sleep duration (adults) [ Time Frame: 14 days (experiment period) ]
    Total sleep duration is defined as time spent asleep within a sleep period, excluding wake time. Total sleep duration is measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+).

  10. Between group change in sleep onset latency (children) [ Time Frame: 14 days (experiment period) ]
    Sleep is measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+). Sleep onset latency is calculated using the EEG-based sleep stages.

  11. Between group change in sleep onset latency (adults) [ Time Frame: 14 days (experiment period) ]
    Sleep is measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+). Sleep onset latency is calculated using the EEG-based sleep stages.

  12. Between group change in wake after sleep onset (children) [ Time Frame: 14 days (experiment period) ]
    Sleep is measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+). Wake after sleep onset is calculated using the EEG-based sleep stages.

  13. Between group change in wake after sleep onset (adults) [ Time Frame: 14 days (experiment period) ]
    Sleep is measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+). Wake after sleep onset is calculated using the EEG-based sleep stages.

  14. Between group change in sleep stages (awake, light sleep, deep sleep, REM-sleep) (children) [ Time Frame: 14 days (experiment period) ]
    Sleep stages are measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+).

  15. Between group change in sleep stages (awake, light sleep, deep sleep, REM-sleep) (adults) [ Time Frame: 14 days (experiment period) ]
    Sleep stages are measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+).


Other Outcome Measures:
  1. Between group change in cortisol awakening response (adults) [ Time Frame: 14 days (experiment period) ]
    Cortisol awakening response is measured using saliva samples. Samples are collected at awakening, 30 minutes after awakening, and 45 minutes after awakening for three consecutive days.

  2. Between group change in diurnal cortisol slope (adults) [ Time Frame: 14 days (experiment period) ]
    The diurnal cortisol slope is measured using saliva samples. Samples are collected at bedtime and immediate after awakening, and the diurnal cortisol slope will be calculated as the difference in waking and bedtime cortisol levels summarized based on assessments over three consecutive days.

  3. Between group change in heart rate variability (HRV) [ Time Frame: 14 days (experiment period) ]
    Heart Rate Variability is recorded for 72 consecutive hours at baseline and follow-up using Firstbeat 2 (time- and frequency domain measures).

  4. Between group change in non-metabolic heart rate variability (adults) [ Time Frame: 14 days (experiment period) ]
    Heart Rate Variability is recorded for 72 consecutive hours at baseline and follow-up using Firstbeat 2. Non-metabolic heart rate variability is quantified by removing the effect of physical activity.

  5. Between group change in mood disturbance score (adults) [ Time Frame: 14 days (experiment period) ]
    Mood states are assessed using the Profile of moods, which is a 65-item questionnaire each item is scored from 0-4. The questionnaire is divided into 6 subscales 1) Tension, 2) Depression, 3) Anger, 4) Fatigue, 5) Confusion, and 6) Vigour. High vigour score represents good mood and low scores on the other subscales represent good mood. The total mood disturbance score is calculated by adding subscales 1-5 and subtracting subscale 6.

  6. Between group change in WHO-5-score (adults) [ Time Frame: 14 days (experiment period) ]
    WHO-5 is a questionnaire measuring current mental well-being. The questionnaire consist of 5 item each scores from 0-5. Scores from each item are added and multiplied by 4. This results in a score between 0-100, lower scores indicate lower mental well-being.

  7. Between group change in the total difficulties score (children) [ Time Frame: 14 days (experiment period) ]
    The strengths and difficulties questionnaire (SDQ) is divided into 5 subscales 1) emotional symptoms scale, 2) conduct problem scale, 3) hyperactivity scale, 4) peer problem scale, and 5) prosocial scale. The subscales are scored from 0-10. Lower scores indicate low difficulties on subscale 1-4. Lower scores indicate low amount of social strengths on subscale 5. The total difficulties score will be calculated from the summary scores from subscale 1-4.

  8. Between group change in subjective sleep quality (adults) [ Time Frame: 14 days (experiment period) ]
    Quality of sleep is assessed using the quality of sleep subscale (item 4-5) from the Leeds Sleep Evaluation Questionnaire. Each item consist of a visual analog scale (0-100), where lower scores = higher symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098913


Contacts
Layout table for location contacts
Contact: Jesper Pedersen, MSc 004565502054 jespedersen@health.sdu.dk
Contact: Martin G Rasmussen, MSc 004565504816 mgrasmussen@health.sdu.dk

Locations
Layout table for location information
Denmark
University of Southern Denmark Recruiting
Odense, Funen, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
European Research Council
Investigators
Layout table for investigator information
Principal Investigator: Anders Grøntved, Ph.D. University of Southern Denamrk
  Study Documents (Full-Text)

Documents provided by University of Southern Denmark:
Statistical Analysis Plan  [PDF] February 21, 2020

Layout table for additonal information
Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04098913    
Other Study ID Numbers: S-20170213 (2)
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
screen time
physical activity
sleep
stress