Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03752385 |
Other study ID # |
6007767 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 1, 2018 |
Est. completion date |
June 30, 2019 |
Study information
Verified date |
November 2018 |
Source |
University of Prince Edward Island |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.