Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2019-06-06
2021-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Reduced screen-based media use
Reducing recreational screen-based media use for a period of 2 weeks.
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.
Control group
Participants are asked to continue their habitual screen-based media use.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
99 Years
ALL
Yes
Sponsors
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European Research Council
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Anders Grøntved, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denamrk
Locations
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University of Southern Denmark
Odense, Funen, Denmark
Countries
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References
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Schmidt-Persson J, Rasmussen MGB, Sorensen SO, Mortensen SR, Olesen LG, Brage S, Kristensen PL, Bilenberg N, Grontved A. Screen Media Use and Mental Health of Children and Adolescents: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419881. doi: 10.1001/jamanetworkopen.2024.19881.
Pedersen J, Rasmussen MGB, Sorensen SO, Mortensen SR, Olesen LG, Brage S, Kristensen PL, Puterman E, Grontved A. Effects of limiting digital screen use on well-being, mood, and biomarkers of stress in adults. Npj Ment Health Res. 2022;1(1):14. doi: 10.1038/s44184-022-00015-6. Epub 2022 Oct 12.
Pedersen J, Rasmussen MGB, Sorensen SO, Mortensen SR, Olesen LG, Brond JC, Brage S, Kristensen PL, Grontved A. Effects of Limiting Recreational Screen Media Use on Physical Activity and Sleep in Families With Children: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Aug 1;176(8):741-749. doi: 10.1001/jamapediatrics.2022.1519.
Rasmussen MGB, Pedersen J, Olesen LG, Brage S, Klakk H, Kristensen PL, Brond JC, Grontved A. Short-term efficacy of reducing screen media use on physical activity, sleep, and physiological stress in families with children aged 4-14: study protocol for the SCREENS randomized controlled trial. BMC Public Health. 2020 Mar 23;20(1):380. doi: 10.1186/s12889-020-8458-6.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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S-20170213 (2)
Identifier Type: -
Identifier Source: org_study_id
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