<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/NCT03263338</url>
  </required_header>
  <id_info>
    <org_study_id>17-014078</org_study_id>
    <nct_id>NCT03263338</nct_id>
  </id_info>
  <brief_title>Mobile Sleep and Growth Study</brief_title>
  <official_title>Mobile Health Sleep and Growth Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to see if we can help parents to get their children to&#xD;
      go to bed earlier. This may help children to improve their sleep. The study will use a&#xD;
      web-based study platform and an activity monitor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">June 6, 2018</completion_date>
  <primary_completion_date type="Actual">October 19, 2017</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>Time in bed</measure>
    <time_frame>50-days</time_frame>
    <description>Time in bed is estimated using a Fitbit activity tracker</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total sleep time</measure>
    <time_frame>50-days</time_frame>
    <description>Total sleep time is estimated using a Fitbit activity tracker</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Childhood Sleep Promotion</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group C.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Sleep and Growth Study</intervention_name>
    <description>The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females age 10 to 12 years.&#xD;
&#xD;
          2. Speak, read and write in English.&#xD;
&#xD;
          3. Parental/guardian permission (informed consent) and child assent.&#xD;
&#xD;
          4. Have a computer or a tablet computer with access to the Internet, or own a smartphone&#xD;
             with a data and text plan.&#xD;
&#xD;
          5. Typically spend 8-9 hours in bed at night (e.g. 8 hour time in bed: go to bed at 10pm&#xD;
             &amp; get out of bed at 6am).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).&#xD;
&#xD;
          2. Syndromic obesity.&#xD;
&#xD;
          3. Diagnosed with a psychiatric disorder [e.g. Attention-deficit/hyperactivity disorder&#xD;
             (ADHD), depression, anxiety].&#xD;
&#xD;
          4. Diagnosed with an eating disorder.&#xD;
&#xD;
          5. Musculoskeletal or neurological disorder that limits physical movement and activity.&#xD;
&#xD;
          6. Use of medications (prescription or otherwise) known to affect body weight and/or&#xD;
             sleep.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Mitchell</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03263338
org study id: 17-014078
nct id: NCT03263338
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to see if we can help parents to get their children to
      go to bed earlier. This may help children to improve their sleep. The study will use a
      web-based study platform and an activity monitor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Time in bed
time frame: 50-days
description: Time in bed is estimated using a Fitbit activity tracker
measure: Total sleep time
time frame: 50-days
description: Total sleep time is estimated using a Fitbit activity tracker
arm group label: Group A
arm group type: Active Comparator
description: Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target.
arm group label: Group B
arm group type: Experimental
description: Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group B.
arm group label: Group C
arm group type: Experimental
description: Participants will select a time in bed target and will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group C.
intervention type: Behavioral
intervention name: Mobile Sleep and Growth Study
description: The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.
arm group label: Group A
arm group label: Group B
arm group label: Group C
criteria: 
gender: All
minimum age: 10 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Mitchell
role: Principal Investigator
affiliation: Research Assistant Professor
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No