Short-term Efficacy of Reducing Screen-based Media Use
Condition: Screen Time
Study type: Interventional

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.
    

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.
    

Intervention name(s): Reduced screen-based media use
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: screen time; physical activity; sleep; stress