Feasibility StudiesNCT03788525
Reduction of Screen-Based Media Use in Families With Children
A study testing Reduced recreational screen time and Timed recreational screen time in people with Feasibility Studies, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this pilot experiment is threefold. 1. To assess the efficacy of the recruitment strategy 2. To assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes 3. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies
- What is being tested?
- Reduced recreational screen time and Timed recreational screen time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- High amount of screen-based media according to self-report (based on the adults only)
- In each household, at least one adult and one child must be above the 50th percentile for self-reported screen-based media use (characterized as "high" in this study). The 50th percentile is based on the responses from all adults who answered the recruitment survey.
- The children in the household are ≥ 4 and ≤ 18 years old, at the time the survey is sent out. In this way sleep measurements do not get distorted by infants and toddlers in the household (e.g. sleep).
- Adults and children who participate in the measurements must have the resources to remove all recreational- and work-/school-related screen-time in the evening hours, with a few exceptions, for a period of 2 weeks (intervention length).
- Participants must report that they consider the extent of their screen-based media use an issue
- Participants must report to be motivated to decrease screen-based media use for the whole family household.
- Family members who choose to not participate or are ineligible must be willing to support the success of this family experiment.
Who cannot join
- If the adults or children only reside in the household part time, i.e. have multiple addresses
- Diagnosis of stress from their general practitioner within the last year
- Diagnosis of sleep disorders from their general practitioner within the last year
- Working night shifts
- In any shape or form limited in one's ability to participate in habitual physical activity
- Has or is in inquiry of Neuropsychiatric disorders, such as Attention Deficit Hyperactivity Disorder (ADHD) or development disorders such as Autism.
- Already participating in research studies, such as the Odense Child Cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Screen-Based Media Use in Families With Children: a Randomized Pilot Trial
The purpose of this pilot experiment is threefold.
- To assess the efficacy of the recruitment strategy
- To assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes
- To assess the acceptability of the prescribed interventions to reduce screen media use
Read the detailed description
Modern day's excessive use of screen-based media is heavily discussed in the public in terms of its possible harmful effects on physical and mental health among children and adults. To date there is little rigorously conducted research available on the effects of high use of todays screen-based media. Of particular notice, no controlled experimental studies in free-living have been carried out to study the immediate effects of screen-based media use on habitual physical activity patterns, sleep, and temporary stress- and emotional state.
To undertake a large-scale randomized controlled trial of the efficacy of limiting screen-based media use in families of parents and children the investigators aim to conduct a pilot study to assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes and the acceptability of the prescribed interventions to reduce screen media use. The investigators also perform the pilot study to investigate the efficacy of our recruitment strategy.
The participating families (households with children ≥4 and <18 years old) will be invited to answer a recruitment questionnaire sent out to their personal digital mailbox, which is a compulsory digital solution to receive mail from i.e. public authorities. Based on the survey answers eligible families (see section on inclusion/exclusion criteria) will be invited to participate in this pilot experiment. Families who are willing to participate will be randomized to one of two intervention groups after completion of the baseline measurement protocol. One group must reduce all recreational screen-based media use to less than three hours per week for a period of two weeks. Participants in this group will be asked to hand over their portable screen devices and in exchange they will be handed an old model Nokia phone. The other group must remove all screen-based media use (both work-related and recreational) after 6PM for a period of two weeks. The experiment does not include a control group. To ensure compliance to the interventions, the investigators will install an app, which will measure screen use on each participant's smartphone(s) and tablet(s). Furthermore, the investigators will connect a device to all televisions in each household, which will monitor television usage. To investigate the effect of the interventions all participants will go through a 7-day measurement protocol just before the family is randomized to one of the interventions and again during the last week of the intervention period.
- Conditions
- Feasibility Studies
- Being tested
- Reduced recreational screen time, Timed recreational screen time
- Keywords
- Screen time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced recreational screen timeBehavioural
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 this device for necessary contact. The families are allowed a maximum of 3 hours/week of recreational screen time. If 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.
Timed recreational screen timeBehavioural
Participants must remove all recreational screen-based media use after 6 PM. There are no restrictions on the amount of screen-based media use before 6 PM. Thus, before 6 PM, the participants must continue their habitual screen-based media use completely. However, after 6 PM, both work-related and recreational screen-based media use must be removed completely.
| Study group | Role | What they receive |
|---|---|---|
| Reduced recreational screen time | Experimental | Reducing recreational screen-based media use for a period of 2 weeks Receives: Behavioral: Reduced recreational screen time |
| Timed recreational screen time | Experimental | Reduced and timed recreational screen-based media use for a period of 2 weeks Receives: Behavioral: Timed recreational screen time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to prescribed intervention (objective assessment)
Proportion of participants who are compliant to the prescribed intervention.
Compliance is assessed objectively using data from the Device Tracker App (installed on all portable devices) and the television monitor installed on all televisions in the household.
Measured: 14 days (experiment period)
Compliance to prescribed intervention (subjective assessment)
Proportion of participants who are compliant to the prescribed intervention.
Compliance is assessed subjectively through a daily screen-media dairy. All participants are required to hold the daily screen-media dairy throughout the experiment period.
Measured: 14 days (experiment period)
Secondary outcomes (5)
Compliance to objective physical activity measurement
Proportion of participants wearing the accelerometer belts (Axivity AX3) for at least four out of seven measurements days at baseline and follow-up (at least one day must be a weekend day).
Measured: 14 days (experiment period)
Compliance to sleep measurement
Proportion of participants wearing the sleep equipment (Zmachine Insight+) for at least two out of three measurement nights at baseline and follow-up.
Measured: 14 days (experiment period)
Compliance to heart rate variability measurement
Proportion of participants wearing the heart rate variability device (Firstbeat Bodyguard 2) for at least two out of three measurement days at baseline and follow-up.
Measured: 14 days (experiment period)
Compliance to saliva sampling protocol (only in adults)
Proportion of participants delivering salivary samples from two out of three measurement days which is equivalent to eight out of twelve samples at baseline and follow-up.
Samples are collected by the participant at awakening, 30 min. after awakening, 45 min. after awakening, and just before bedtime.
Measured: 14 days (experiment period)
Feasibility of the recruitment strategy
Proportion of invited participants completing the full experiment period. Participants are invited and recruited continuously throughout the study.
Measured: Up to four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start12 Nov 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Sponsor
- Investigators
- Anders Grøntved, Ph.D., Principal investigator, University of Southern Denamrk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788525
- Sponsor's protocol ID
- S-20170213
- Other IDs
- 716657
- Status last verified
- May 2022
- First submitted
- 20 Dec 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasmussen MGB, Pedersen J, Olesen LG, Kristensen PL, Brond JC, Grontved A. Feasibility of two screen media reduction interventions: Results from the SCREENS pilot trial. PLoS One. 2021 Nov 15;16(11):e0259657. doi: 10.1371/journal.pone.0259657. eCollection 2021.
PubMed 34780511Sorensen SO, Pedersen J, Rasmussen MG, Kristensen PL, Grontved A. Feasibility of home-based sampling of salivary cortisol and cortisone in healthy adults. BMC Res Notes. 2021 Nov 2;14(1):406. doi: 10.1186/s13104-021-05820-4.
PubMed 34727972Pedersen J, Rasmussen M G B, Olesen L G, Kristensen P L, Grøntved A. Self-administered electroencephalography-based sleep assessment: compliance and perceived feasibility in children and adults. Sleep Science and Practice. 2021; 5(1):8. doi.org/10.1186/s41606-021-00059-1
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Screen-Based Media Use in Families With Children: a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT03788525
- Acronym / sponsor ID
- S-20170213
- Conditions
- Feasibility Studies
- Keywords
- Screen time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot experiment is threefold.
- To assess the efficacy of the recruitment strategy
- To assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes
- To assess the acceptability of the prescribed interventions to reduce screen media use
Detailed description
Modern day's excessive use of screen-based media is heavily discussed in the public in terms of its possible harmful effects on physical and mental health among children and adults. To date there is little rigorously conducted research available on the effects of high use of todays screen-based media. Of particular notice, no controlled experimental studies in free-living have been carried out to study the immediate effects of screen-based media use on habitual physical activity patterns, sleep, and temporary stress- and emotional state.
To undertake a large-scale randomized controlled trial of the efficacy of limiting screen-based media use in families of parents and children the investigators aim to conduct a pilot study to assess the acceptability and feasibility of the outcome measurement methods obtained in free-living in the participants homes and the acceptability of the prescribed interventions to reduce screen media use. The investigators also perform the pilot study to investigate the efficacy of our recruitment strategy.
The participating families (households with children ≥4 and <18 years old) will be invited to answer a recruitment questionnaire sent out to their personal digital mailbox, which is a compulsory digital solution to receive mail from i.e. public authorities. Based on the survey answers eligible families (see section on inclusion/exclusion criteria) will be invited to participate in this pilot experiment. Families who are willing to participate will be randomized to one of two intervention groups after completion of the baseline measurement protocol. One group must reduce all recreational screen-based media use to less than three hours per week for a period of two weeks. Participants in this group will be asked to hand over their portable screen devices and in exchange they will be handed an old model Nokia phone. The other group must remove all screen-based media use (both work-related and recreational) after 6PM for a period of two weeks. The experiment does not include a control group. To ensure compliance to the interventions, the investigators will install an app, which will measure screen use on each participant's smartphone(s) and tablet(s). Furthermore, the investigators will connect a device to all televisions in each household, which will monitor television usage. To investigate the effect of the interventions all participants will go through a 7-day measurement protocol just before the family is randomized to one of the interventions and again during the last week of the intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced recreational screen time | Experimental | Behavioral: Reduced recreational screen timeReducing recreational screen-based media use for a period of 2 weeks |
| Timed recreational screen time | Experimental | Behavioral: Timed recreational screen timeReduced and timed recreational screen-based media use for a period of 2 weeks |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- High amount of screen-based media according to self-report (based on the adults only)
- In each household, at least one adult and one child must be above the 50th percentile for self-reported screen-based media use (characterized as "high" in this study). The 50th percentile is based on the responses from all adults who answered the recruitment survey.
- The children in the household are ≥ 4 and ≤ 18 years old, at the time the survey is sent out. In this way sleep measurements do not get distorted by infants and toddlers in the household (e.g. sleep).
- Adults and children who participate in the measurements must have the resources to remove all recreational- and work-/school-related screen-time in the evening hours, with a few exceptions, for a period of 2 weeks (intervention length).
- Participants must report that they consider the extent of their screen-based media use an issue
Key exclusion criteria (7 listed)
- If the adults or children only reside in the household part time, i.e. have multiple addresses
- Diagnosis of stress from their general practitioner within the last year
- Diagnosis of sleep disorders from their general practitioner within the last year
- Working night shifts
- In any shape or form limited in one's ability to participate in habitual physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced recreational screen timeParticipants 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 this device for necessary contact. The families are allowed a maximum of 3 hours/week of recreational screen time. If 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. | Behavioural | Reduced recreational screen time |
| Timed recreational screen timeParticipants must remove all recreational screen-based media use after 6 PM. There are no restrictions on the amount of screen-based media use before 6 PM. Thus, before 6 PM, the participants must continue their habitual screen-based media use completely. However, after 6 PM, both work-related and recreational screen-based media use must be removed completely. | Behavioural | Timed recreational screen time |
Primary outcome
Compliance to prescribed intervention (objective assessment)
Time frame: 14 days (experiment period)
Proportion of participants who are compliant to the prescribed intervention. Compliance is assessed objectively using data from the Device Tracker App (installed on all portable devices) and the television monitor installed on all televisions in the household.
Compliance to prescribed intervention (subjective assessment)
Time frame: 14 days (experiment period)
Proportion of participants who are compliant to the prescribed intervention. Compliance is assessed subjectively through a daily screen-media dairy. All participants are required to hold the daily screen-media dairy throughout the experiment period.
5 secondary outcomes
Compliance to objective physical activity measurement
Time frame: 14 days (experiment period)
Compliance to sleep measurement
Time frame: 14 days (experiment period)
Compliance to heart rate variability measurement
Time frame: 14 days (experiment period)
Compliance to saliva sampling protocol (only in adults)
Time frame: 14 days (experiment period)
Feasibility of the recruitment strategy
Time frame: Up to four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Results publication: PubMed 34780511Rasmussen MGB, Pedersen J, Olesen LG, Kristensen PL, Brond JC, Grontved A. Feasibility of two screen media reduction interventions: Results from the SCREENS pilot trial. PLoS One. 2021 Nov 15;16(11):e0259657. doi: 10.1371/journal.pone.0259657. eCollection 2021.
- Results publication: PubMed 34727972Sorensen SO, Pedersen J, Rasmussen MG, Kristensen PL, Grontved A. Feasibility of home-based sampling of salivary cortisol and cortisone in healthy adults. BMC Res Notes. 2021 Nov 2;14(1):406. doi: 10.1186/s13104-021-05820-4.
- Results publicationPedersen J, Rasmussen M G B, Olesen L G, Kristensen P L, Grøntved A. Self-administered electroencephalography-based sleep assessment: compliance and perceived feasibility in children and adults. Sleep Science and Practice. 2021; 5(1):8. doi.org/10.1186/s41606-021-00059-1
- Feasibility of two screen media reduction interventions: Results from the SCREENS pilot trial. PLoS One. 2021 Nov 15;16(11):e0259657. doi: 10.1371/journal.pone.0259657. eCollectionLink provided by the sponsor.
- Feasibility of home-based sampling of salivary cortisol and cortisone in healthy adults. BMC Res Notes. 2021 Nov 2;14(1):406. doi: 10.1186/s13104-021-05820-4.Link provided by the sponsor.
- Self-administered electroencephalography-based sleep assessment: compliance and perceived feasibility in children and adults. Sleep Science and Practice. 2021; 5(1):8. doi.org/10.1186/s4Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Grøntved, Ph.D. principal investigator
University of Southern Denamrk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced recreational screen time and Timed recreational screen time in people with Feasibility Studies, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to prescribed intervention (objective assessment) (time frame: 14 days (experiment period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03788525, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.