Sedentary LifestyleNCT03752385
The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being
A study testing reducing smartphone screen time in people with Sedentary Lifestyle, run by University of Prince Edward Island at 1 site in Canada.
Trial summary
Previous studies suggest that screen use (phones, TV, computers, etc) may negatively impact both sleep and mental health (1-3). The purpose of this study is to determine the impact of reducing smartphone use on sleep, physical activity, sedentary behaviour, and mental health in adolescents and young adults aged 13-25. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- reducing smartphone screen time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 30 Jun 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 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must be between the ages of 13 and 25 years of age, own an iPhone, use their phone more than 2 hours/day at baseline and be able to read and write in English.
Who cannot join
- Outside age limits, does not own an iPhone, cannot read and write in English.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Prince Edward Island
Charlottetown, Prince Edward Island, C1A 4P3
About this study
Previous studies suggest that screen use (phones, TV, computers, etc) may negatively impact both sleep and mental health (1-3). The purpose of this study is to determine the impact of reducing smartphone use on sleep, physical activity, sedentary behaviour, and mental health in adolescents and young adults aged 13-25.
Read the detailed description
Participants will be asked to visit the Active Living Lab on 3 occasions. We expect each visit to take 30-60 minutes.
At baseline, participants will meet with members of the research team to provide informed consent (ages 16+) or parent/guardian consent + participant assent (ages 13-15). Researchers will then record participants' baseline age, gender, height and weight. Participants will then be instructed to download the In The Moment iPhone application which will be used to measure smartphone use. Upon leaving the lab, all participants will be provided with an ActivPAL inclinometer to be worn on the leg, and a Fitbit Flex to be worn on the wrist for 7 days to measure sedentary behaviour, physical activity and sleep.
Following the week of baseline data collection, participants will return to the lab to complete a series of questionnaires focusing on self-reported sedentary behaviour (International Sedentary Assessment Tool, Sedentary Disorder Scale, Social Media Disorder Scale and SHAPES sedentary behaviour questionnaire), physical activity (International Physical Activity Questionnaire), sleep (Pittsburgh Sleep Index), food intake (SHAPES food frequency questionnaire) and mental health (Positive and Negative Affect Schedule and Center for Epidemiologic Studies Depression Scale). At this time participants will also be asked to write down the daily time spent using social media apps (this information can be found under Settings on their iPhone). After completing the questionnaires, participants will be told whether they are in the Intervention or Control groups.
Participants in the intervention group will be asked to restrict their daily smartphone use by 50%, compared to the week of baseline testing. This will be achieved via the OurPact app, which allows the researchers to limit smartphone use to a specific amount of daily use for 7 days (participants will be asked to download and install the app after being told they are in the Intervention group). Once participants have used their allotted daily smartphone time, entertainment apps will not function until the timer is reset the following day (the address book and calling functions are never restricted, so participants will continue to be able to make/receive phone calls, and access their address book at all times). Participants will also be asked to determine a nightly "bedtime", after which their smartphone will be able to make/receive calls, but no other applications will be available. Participants in the intervention group will also be asked to leave their phones outside of their bedroom at night, and will be provided with a digital alarm clock to reduce the use of phones for this purpose.
Participants in the control group will be asked to maintain their typical daily smartphone use for 7 additional days.
After the 7 day intervention/control period, participants will return to the lab to complete the questionnaires for a second time, and to return the Fitbit and inclinometer, and have the apps removed from their phones. Participants in the Intervention group will also be asked to complete a questionnaire on their experience with the intervention, and to provide any additional comments on their experience in the intervention.
- Conditions
- Sedentary Lifestyle
- Being tested
- reducing smartphone screen time
- Keywords
- smartphone, screen time, sedentary behaviour, physical activity, mental health, sleep, adolescents, young adults
- Medical subject headings
- Sedentary Behavior, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reducing smartphone screen timeBehavioural
Cutting average smartphone screen time in half. Sleeping without smartphone in bedroom. Establishing a "bedtime" to stop smartphone screen time.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention |
| Intervention Group | Experimental | Will cut their smartphone screen time in half, sleep without phone in bedroom, and have a "bedtime" for their phone use. Receives: Behavioral: reducing smartphone screen time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Positive and Negative Affect
Data will be collected using the PANAS scale. Scores for both Positive and Negative Affect range from 10-50, with higher scores representing higher levels of each.
Measured: Measured after the first and second week of study.
Changes in Depression Symptoms
Data will be collected using the CES-D scale. Scores range from 0-60, with higher scores indicating the presence of more symptomatology
Measured: Measured after the first and second week of study.
Secondary outcomes (5)
Changes in Self-Reported Food Intake
Data will be collected using a food frequency questionnaire
Measured: Measured after the first and second week of study.
Changes in body mass index
Calculated using measured height and weight.
Measured: Measured after the first and second week of study.
Changes in sleep quality and quantity
Data will be collected using the Pittsburgh Sleep Quality Index
Measured: Measured after the first and second week of study.
Changes in Physical Activity
Will be assessed via Fitbit
Measured: Measured after the first and second week of study.
Changes in Sedentary Behaviour
Will be measured via ActivPAL inclinometer
Measured: Measured after the first and second week of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Travis Saunders, PHD, Principal investigator, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752385
- Sponsor's protocol ID
- 6007767
- Status last verified
- Nov 2018
- First submitted
- 12 Oct 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being
- ClinicalTrials.gov ID
- NCT03752385
- Acronym / sponsor ID
- 6007767
- Conditions
- Sedentary Lifestyle
- Keywords
- smartphone, screen time, sedentary behaviour, physical activity, mental health, sleep, adolescents, young adults
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Nov 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.
Previous studies suggest that screen use (phones, TV, computers, etc) may negatively impact both sleep and mental health (1-3). The purpose of this study is to determine the impact of reducing smartphone use on sleep, physical activity, sedentary behaviour, and mental health in adolescents and young adults aged 13-25.
Detailed description
Participants will be asked to visit the Active Living Lab on 3 occasions. We expect each visit to take 30-60 minutes.
At baseline, participants will meet with members of the research team to provide informed consent (ages 16+) or parent/guardian consent + participant assent (ages 13-15). Researchers will then record participants' baseline age, gender, height and weight. Participants will then be instructed to download the In The Moment iPhone application which will be used to measure smartphone use. Upon leaving the lab, all participants will be provided with an ActivPAL inclinometer to be worn on the leg, and a Fitbit Flex to be worn on the wrist for 7 days to measure sedentary behaviour, physical activity and sleep.
Following the week of baseline data collection, participants will return to the lab to complete a series of questionnaires focusing on self-reported sedentary behaviour (International Sedentary Assessment Tool, Sedentary Disorder Scale, Social Media Disorder Scale and SHAPES sedentary behaviour questionnaire), physical activity (International Physical Activity Questionnaire), sleep (Pittsburgh Sleep Index), food intake (SHAPES food frequency questionnaire) and mental health (Positive and Negative Affect Schedule and Center for Epidemiologic Studies Depression Scale). At this time participants will also be asked to write down the daily time spent using social media apps (this information can be found under Settings on their iPhone). After completing the questionnaires, participants will be told whether they are in the Intervention or Control groups.
Participants in the intervention group will be asked to restrict their daily smartphone use by 50%, compared to the week of baseline testing. This will be achieved via the OurPact app, which allows the researchers to limit smartphone use to a specific amount of daily use for 7 days (participants will be asked to download and install the app after being told they are in the Intervention group). Once participants have used their allotted daily smartphone time, entertainment apps will not function until the timer is reset the following day (the address book and calling functions are never restricted, so participants will continue to be able to make/receive phone calls, and access their address book at all times). Participants will also be asked to determine a nightly "bedtime", after which their smartphone will be able to make/receive calls, but no other applications will be available. Participants in the intervention group will also be asked to leave their phones outside of their bedroom at night, and will be provided with a digital alarm clock to reduce the use of phones for this purpose.
Participants in the control group will be asked to maintain their typical daily smartphone use for 7 additional days.
After the 7 day intervention/control period, participants will return to the lab to complete the questionnaires for a second time, and to return the Fitbit and inclinometer, and have the apps removed from their phones. Participants in the Intervention group will also be asked to complete a questionnaire on their experience with the intervention, and to provide any additional comments on their experience in the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention |
| Intervention Group | Experimental | Behavioral: reducing smartphone screen timeWill cut their smartphone screen time in half, sleep without phone in bedroom, and have a "bedtime" for their phone use. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants must be between the ages of 13 and 25 years of age, own an iPhone, use their phone more than 2 hours/day at baseline and be able to read and write in English.
Key exclusion criteria (1 listed)
- Outside age limits, does not own an iPhone, cannot read and write in English.
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 |
|---|---|---|
| reducing smartphone screen timeCutting average smartphone screen time in half. Sleeping without smartphone in bedroom. Establishing a "bedtime" to stop smartphone screen time. | Behavioural | Intervention Group |
Primary outcome
Changes in Positive and Negative Affect
Time frame: Measured after the first and second week of study.
Data will be collected using the PANAS scale. Scores for both Positive and Negative Affect range from 10-50, with higher scores representing higher levels of each.
Changes in Depression Symptoms
Time frame: Measured after the first and second week of study.
Data will be collected using the CES-D scale. Scores range from 0-60, with higher scores indicating the presence of more symptomatology
5 secondary outcomes
Changes in Self-Reported Food Intake
Time frame: Measured after the first and second week of study.
Changes in body mass index
Time frame: Measured after the first and second week of study.
Changes in sleep quality and quantity
Time frame: Measured after the first and second week of study.
Changes in Physical Activity
Time frame: Measured after the first and second week of study.
Changes in Sedentary Behaviour
Time frame: Measured after the first and second week of study.
Results and safety
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Related trials for Sedentary Lifestyle
RecruitingObservational study
Pregnancy 24/7 Offspring Study
Healthy
Recruiting
Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
Cardiovascular Diseases (CVD), Coronary Disease
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
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.
Travis Saunders, PHD principal investigator
University of Prince Edward Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reducing smartphone screen time in people with Sedentary Lifestyle, run by University of Prince Edward Island at 1 site in Canada.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Jan 2021. 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 Canada. 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 was stopped early (reason given: Lack of funding.). Results are not available in the source record.
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?
Changes in Positive and Negative Affect (time frame: Measured after the first and second week of study.). 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?
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 29 Jan 2021.