Short-term Efficacy of Reducing Screen-based Media Use

NCT ID: NCT04098913

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2021-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Screen Time

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reduced screen-based media use

Reducing recreational screen-based media use for a period of 2 weeks.

Group Type EXPERIMENTAL

Reduced screen-based media use

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Research Council

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Grøntved, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denamrk

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Southern Denmark

Odense, Funen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38995646 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37521498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35604678 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32293374 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-20170213 (2)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Games & Well-Being Study
NCT01886911 COMPLETED NA