Clinical trial NCT04098913: Short-term Efficacy of Reducing Screen-based Media Use
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screen Time
Keywords: screen time
physical activity
sleep
stress
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2019-09-23
Enrollment: 92
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Between group change in leisure time spent being non-sedentary (children)
timeFrame: 14 days (experiment period)
Secondary outcomes:
measure: Between group change in leisure time spent being non-sedentary(adults)
timeFrame: 14 days (experiment period)
measure: Between group change in leisure time moderate to vigorous physical activity (MVPA) (children)
timeFrame: 14 days (experiment period)
measure: Between group change in leisure time moderate to vigorous physical activity MVPA (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in leisure time spent being non-sedentary on weekdays (children)
timeFrame: 14 days (experiment period)
measure: Between group change in leisure time spent being non-sedentary on weekdays (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in leisure time spent being non-sedentary on weekend days (children)
timeFrame: 14 days (experiment period)
measure: Between group change in leisure time spent being non-sedentary on weekend days (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in total sleep duration (children)
timeFrame: 14 days (experiment period)
measure: Between group change in total sleep duration (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in sleep onset latency (children)
timeFrame: 14 days (experiment period)
measure: Between group change in sleep onset latency (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in wake after sleep onset (children)
timeFrame: 14 days (experiment period)
measure: Between group change in wake after sleep onset (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in sleep stages (awake, light sleep, deep sleep, REM-sleep) (children)
timeFrame: 14 days (experiment period)
measure: Between group change in sleep stages (awake, light sleep, deep sleep, REM-sleep) (adults)
timeFrame: 14 days (experiment period)
Other outcomes:
measure: Between group change in cortisol awakening response (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in diurnal cortisol slope (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in heart rate variability (HRV)
timeFrame: 14 days (experiment period)
measure: Between group change in non-metabolic heart rate variability (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in mood disturbance score (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in WHO-5-score (adults)
timeFrame: 14 days (experiment period)
measure: Between group change in the total difficulties score (children)
timeFrame: 14 days (experiment period)
measure: Between group change in subjective sleep quality (adults)
timeFrame: 14 days (experiment period)
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Funen
Study officials:
affiliation: University of Southern Denamrk
name: Anders Grøntved, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.