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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
92
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.
University of Southern Denmark
Odense, Funen, Denmark
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).
Time frame: 14 days (experiment period)
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).
Time frame: 14 days (experiment period)
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).
Time frame: 14 days (experiment period)
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).
Time frame: 14 days (experiment period)
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).
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Time frame: 14 days (experiment period)
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).
Time frame: 14 days (experiment period)
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).
Time frame: 14 days (experiment period)
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).
Time frame: 14 days (experiment period)
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+).
Time frame: 14 days (experiment period)
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+).
Time frame: 14 days (experiment period)
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.
Time frame: 14 days (experiment period)
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.
Time frame: 14 days (experiment period)
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.
Time frame: 14 days (experiment period)
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.
Time frame: 14 days (experiment period)
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+).
Time frame: 14 days (experiment period)
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+).
Time frame: 14 days (experiment period)