Short-term Efficacy of Reducing Screen-based Media Use

Screen Time Clinical Trial

— SCREENS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098913
• Other study ID #: S-20170213 (2)
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Screen Time

Intervention

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.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Funen

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	European Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Between group change in cortisol awakening response (adults)	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.	14 days (experiment period)
Other	Between group change in diurnal cortisol slope (adults)	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.	14 days (experiment period)
Other	Between group change in heart rate variability (HRV)	Heart Rate Variability is recorded for 72 consecutive hours at baseline and follow-up using Firstbeat 2 (time- and frequency domain measures).	14 days (experiment period)
Other	Between group change in non-metabolic heart rate variability (adults)	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.	14 days (experiment period)
Other	Between group change in mood disturbance score (adults)	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.	14 days (experiment period)
Other	Between group change in WHO-5-score (adults)	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.	14 days (experiment period)
Other	Between group change in the total difficulties score (children)	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.	14 days (experiment period)
Other	Between group change in subjective sleep quality (adults)	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.	14 days (experiment period)
Primary	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	Between group change in leisure time spent being non-sedentary(adults)	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	Between group change in leisure time moderate to vigorous physical activity (MVPA) (children)	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	Between group change in leisure time moderate to vigorous physical activity MVPA (adults)	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	Between group change in leisure time spent being non-sedentary on weekdays (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	Between group change in leisure time spent being non-sedentary on weekdays (adults)	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	Between group change in leisure time spent being non-sedentary on weekend days (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	Between group change in leisure time spent being non-sedentary on weekend days (adults)	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	Between group change in total sleep duration (children)	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+).	14 days (experiment period)
Secondary	Between group change in total sleep duration (adults)	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+).	14 days (experiment period)
Secondary	Between group change in sleep onset latency (children)	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.	14 days (experiment period)
Secondary	Between group change in sleep onset latency (adults)	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.	14 days (experiment period)
Secondary	Between group change in wake after sleep onset (children)	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 days (experiment period)
Secondary	Between group change in wake after sleep onset (adults)	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 days (experiment period)
Secondary	Between group change in sleep stages (awake, light sleep, deep sleep, REM-sleep) (children)	Sleep stages are measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+).	14 days (experiment period)
Secondary	Between group change in sleep stages (awake, light sleep, deep sleep, REM-sleep) (adults)	Sleep stages are measured for three consecutive nights at baseline and follow-up using single channel EEG-based sleep equipment (Zmachine insight+).	14 days (experiment period)