<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/NCT02229409</url>
  </required_header>
  <id_info>
    <org_study_id>WD-PILOT-2014</org_study_id>
    <nct_id>NCT02229409</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population</brief_title>
  <official_title>Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MeYou Health, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MeYou Health, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the product Walkadoo to determine whether it effectively increases&#xD;
      walking behavior in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average steps per day</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observation only, no behavioral intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Walkadoo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walkadoo</intervention_name>
    <description>Walkadoo is a MeYou Health, LLC product.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years or older;&#xD;
&#xD;
          -  Healthways employees based in Franklin, TN with an email account with the company;&#xD;
&#xD;
          -  Provide informed consent and complete eligibility questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior use of the intervention Walkadoo&#xD;
&#xD;
          -  Presence of a chronic condition that affects walking&#xD;
&#xD;
          -  Projected inability to access the internet for 4 consecutive days or longer during the&#xD;
             study&#xD;
&#xD;
          -  Non-adherence to device wear during baseline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan K Cobb, MD</last_name>
    <role>Study Director</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MeYou Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>February 3, 2016</last_update_submitted>
  <last_update_submitted_qc>February 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adults</keyword>
  <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/NCT02229409
org study id: WD-PILOT-2014
nct id: NCT02229409
lead sponsor: 
has dmc: No
This study evaluates the product Walkadoo to determine whether it effectively increases
      walking behavior in healthy adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average steps per day
time frame: 6 weeks
arm group label: Control
arm group type: No Intervention
description: Observation only, no behavioral intervention
arm group label: Intervention
arm group type: Experimental
description: Intervention Walkadoo.
intervention type: Behavioral
intervention name: Walkadoo
description: Walkadoo is a MeYou Health, LLC product.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nathan K Cobb, MD
role: Study Director
affiliation: Georgetown University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No