<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03752385</url>
  </required_header>
  <id_info>
    <org_study_id>6007767</org_study_id>
    <nct_id>NCT03752385</nct_id>
  </id_info>
  <brief_title>The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being</brief_title>
  <official_title>The Effects of Smartphone Use on Physical Activity, Sedentary Behaviour, Sleep, and Well-being</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Prince Edward Island</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Prince Edward Island</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies suggest that screen use (phones, TV, computers, etc) may negatively impact&#xD;
      both sleep and mental health (1-3). The purpose of this study is to determine the impact of&#xD;
      reducing smartphone use on sleep, physical activity, sedentary behaviour, and mental health&#xD;
      in adolescents and young adults aged 13-25.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be asked to visit the Active Living Lab on 3 occasions. We expect each&#xD;
      visit to take 30-60 minutes.&#xD;
&#xD;
      At baseline, participants will meet with members of the research team to provide informed&#xD;
      consent (ages 16+) or parent/guardian consent + participant assent (ages 13-15). Researchers&#xD;
      will then record participants' baseline age, gender, height and weight. Participants will&#xD;
      then be instructed to download the In The Moment iPhone application which will be used to&#xD;
      measure smartphone use. Upon leaving the lab, all participants will be provided with an&#xD;
      ActivPAL inclinometer to be worn on the leg, and a Fitbit Flex to be worn on the wrist for 7&#xD;
      days to measure sedentary behaviour, physical activity and sleep.&#xD;
&#xD;
      Following the week of baseline data collection, participants will return to the lab to&#xD;
      complete a series of questionnaires focusing on self-reported sedentary behaviour&#xD;
      (International Sedentary Assessment Tool, Sedentary Disorder Scale, Social Media Disorder&#xD;
      Scale and SHAPES sedentary behaviour questionnaire), physical activity (International&#xD;
      Physical Activity Questionnaire), sleep (Pittsburgh Sleep Index), food intake (SHAPES food&#xD;
      frequency questionnaire) and mental health (Positive and Negative Affect Schedule and Center&#xD;
      for Epidemiologic Studies Depression Scale). At this time participants will also be asked to&#xD;
      write down the daily time spent using social media apps (this information can be found under&#xD;
      Settings on their iPhone). After completing the questionnaires, participants will be told&#xD;
      whether they are in the Intervention or Control groups.&#xD;
&#xD;
      Participants in the intervention group will be asked to restrict their daily smartphone use&#xD;
      by 50%, compared to the week of baseline testing. This will be achieved via the OurPact app,&#xD;
      which allows the researchers to limit smartphone use to a specific amount of daily use for 7&#xD;
      days (participants will be asked to download and install the app after being told they are in&#xD;
      the Intervention group). Once participants have used their allotted daily smartphone time,&#xD;
      entertainment apps will not function until the timer is reset the following day (the address&#xD;
      book and calling functions are never restricted, so participants will continue to be able to&#xD;
      make/receive phone calls, and access their address book at all times). Participants will also&#xD;
      be asked to determine a nightly &quot;bedtime&quot;, after which their smartphone will be able to&#xD;
      make/receive calls, but no other applications will be available. Participants in the&#xD;
      intervention group will also be asked to leave their phones outside of their bedroom at&#xD;
      night, and will be provided with a digital alarm clock to reduce the use of phones for this&#xD;
      purpose.&#xD;
&#xD;
      Participants in the control group will be asked to maintain their typical daily smartphone&#xD;
      use for 7 additional days.&#xD;
&#xD;
      After the 7 day intervention/control period, participants will return to the lab to complete&#xD;
      the questionnaires for a second time, and to return the Fitbit and inclinometer, and have the&#xD;
      apps removed from their phones. Participants in the Intervention group will also be asked to&#xD;
      complete a questionnaire on their experience with the intervention, and to provide any&#xD;
      additional comments on their experience in the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding.&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Positive and Negative Affect</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Depression Symptoms</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>Data will be collected using the CES-D scale. Scores range from 0-60, with higher scores indicating the presence of more symptomatology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Self-Reported Food Intake</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>Data will be collected using a food frequency questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body mass index</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>Calculated using measured height and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleep quality and quantity</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>Data will be collected using the Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Physical Activity</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>Will be assessed via Fitbit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sedentary Behaviour</measure>
    <time_frame>Measured after the first and second week of study.</time_frame>
    <description>Will be measured via ActivPAL inclinometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will cut their smartphone screen time in half, sleep without phone in bedroom, and have a &quot;bedtime&quot; for their phone use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>reducing smartphone screen time</intervention_name>
    <description>Cutting average smartphone screen time in half. Sleeping without smartphone in bedroom. Establishing a &quot;bedtime&quot; to stop smartphone screen time.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be between the ages of 13 and 25 years of age, own an iPhone, use&#xD;
             their phone more than 2 hours/day at baseline and be able to read and write in&#xD;
             English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside age limits, does not own an iPhone, cannot read and write in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Travis Saunders, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Prince Edward Island</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Prince Edward Island</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <zip>C1A 4P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smartphone</keyword>
  <keyword>screen time</keyword>
  <keyword>sedentary behaviour</keyword>
  <keyword>physical activity</keyword>
  <keyword>mental health</keyword>
  <keyword>sleep</keyword>
  <keyword>adolescents</keyword>
  <keyword>young adults</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03752385
org study id: 6007767
nct id: NCT03752385
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in Positive and Negative Affect
time frame: Measured after the first and second week of study.
description: 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.
measure: Changes in Depression Symptoms
time frame: Measured after the first and second week of study.
description: Data will be collected using the CES-D scale. Scores range from 0-60, with higher scores indicating the presence of more symptomatology
measure: Changes in Self-Reported Food Intake
time frame: Measured after the first and second week of study.
description: Data will be collected using a food frequency questionnaire
measure: Changes in body mass index
time frame: Measured after the first and second week of study.
description: Calculated using measured height and weight.
measure: Changes in sleep quality and quantity
time frame: Measured after the first and second week of study.
description: Data will be collected using the Pittsburgh Sleep Quality Index
measure: Changes in Physical Activity
time frame: Measured after the first and second week of study.
description: Will be assessed via Fitbit
measure: Changes in Sedentary Behaviour
time frame: Measured after the first and second week of study.
description: Will be measured via ActivPAL inclinometer
arm group label: Control Group
arm group type: No Intervention
description: No intervention
arm group label: Intervention Group
arm group type: Experimental
description: Will cut their smartphone screen time in half, sleep without phone in bedroom, and have a "bedtime" for their phone use.
intervention type: Behavioral
intervention name: reducing smartphone screen time
description: Cutting average smartphone screen time in half. Sleeping without smartphone in bedroom. Establishing a "bedtime" to stop smartphone screen time.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Travis Saunders, PHD
role: Principal Investigator
affiliation: University of Prince Edward Island
facility: 
country: Canada
responsible party type: Sponsor