- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03752385
The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 4P3
- University of Prince Edward Island
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Outside age limits, does not own an iPhone, cannot read and write in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No intervention
|
|
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Experimental: Intervention Group
Will cut their smartphone screen time in half, sleep without phone in bedroom, and have a "bedtime" for their phone use.
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Cutting average smartphone screen time in half.
Sleeping without smartphone in bedroom.
Establishing a "bedtime" to stop smartphone screen time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measured after the first and second week of study.
|
|
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
|
Measured after the first and second week of study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Self-Reported Food Intake
Time Frame: Measured after the first and second week of study.
|
Data will be collected using a food frequency questionnaire
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Measured after the first and second week of study.
|
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Changes in body mass index
Time Frame: Measured after the first and second week of study.
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Calculated using measured height and weight.
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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.
|
Data will be collected using the Pittsburgh Sleep Quality Index
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Measured after the first and second week of study.
|
|
Changes in Physical Activity
Time Frame: Measured after the first and second week of study.
|
Will be assessed via Fitbit
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Measured after the first and second week of study.
|
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Changes in Sedentary Behaviour
Time Frame: Measured after the first and second week of study.
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Will be measured via ActivPAL inclinometer
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Measured after the first and second week of study.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Travis Saunders, PHD, University of Prince Edward Island
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6007767
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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