<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/NCT03010163</url>
  </required_header>
  <id_info>
    <org_study_id>16-1659</org_study_id>
    <nct_id>NCT03010163</nct_id>
  </id_info>
  <brief_title>Taxi STEP (Social Networks, Technology, and Exercise Through Pedometers)</brief_title>
  <official_title>Taxi STEP (Social Networks, Technology, and Exercise Through Pedometers)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC taxi&#xD;
      garage bases and airport taxi holding lots and pedometers. Group 2 includes Health Fairs,&#xD;
      pedometers and text messaging to facilitate walking and living a healthier lifestyle. Group 3&#xD;
      includes Health Fairs, pedometers and social network support. Group 4 includes Health Fairs,&#xD;
      pedometers, text messaging and social network support.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase average daily step counts</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>Increase average step counts per day</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">290</enrollment>
  <condition>Physical Conditioning</condition>
  <arm_group>
    <arm_group_label>Health Fair + Pedometer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will get free weight, height, waist, and blood pressure testing at health fairs stationed at NYC taxi garage bases and airport taxi holding lots. Health fair staff will follow up with participants who need to see a doctor due to a high blood pressure reading or other unusual result that needs a physician follow-up. All participants will be given a pedometer with instructions on how to use it to track their daily step counts. Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Fair, Pedometer + Text Messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the health fair services with general follow-up, and giving each driver a pedometer with instructions on how to use the devise to track daily step counts, all participants in this group will receive daily healthy living advice and encouraging messages about walking through text messages sent by study staff to participants' cellular phone. Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Fair, Pedometer, Social Network Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant in this group will receive the health fair services with general follow-up along with a pedometer with instructions on how to use the device to track daily step counts. Additionally, participants in this group will be asked to provide the names of family or friends who will form a social support network team. This team will provide encouragement and remind participants to maintain a healthy lifestyle and increase daily walking activities. Participants will be given a social network guide to train their family and/or friends on how to best motivate the participants . Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Fair, Pedometer, Text Msg, Social Network Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive the health fair service with general follow-up, along with a pedometer with instructions on how to use the device to track daily step counts. Participants will also receive daily healthy living advice through encouraging text messages about walking through text messages sent by our staff to participants' cellular phones. Participants will also be asked to provide the names of family or friends who will form a social support network team. This team will provide encouragement and remind participants to maintain a healthy lifestyle and increase daily walking activities. Participants will be given tools to train their family and/or friends on how to best motivate the drivers. Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Fair</intervention_name>
    <description>Testing includes weight, height, waist and blood pressure testing. In the event that the participants are unable to meet in person for health measurements, the staff will accept self-reported measurements over the phone.</description>
    <arm_group_label>Health Fair + Pedometer</arm_group_label>
    <arm_group_label>Health Fair, Pedometer + Text Messaging</arm_group_label>
    <arm_group_label>Health Fair, Pedometer, Social Network Support</arm_group_label>
    <arm_group_label>Health Fair, Pedometer, Text Msg, Social Network Support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pedometer</intervention_name>
    <description>The Fitbit One/Alta/Inspire wireless tracking pedometers measures steps taken, calories burned, distance traveled and sleep pattern. The Fitbit Alta/Inspire also sends reminders to move, which are notifications that remind the wearer to walk at least 250 steps each hour. If the wearer has not walked 250 steps within the hour, the device will vibrate and send an on-screen reminder 10 minutes before the hour. The reminders to move will be turned off during baseline and will be turned on at randomization for all participants.</description>
    <arm_group_label>Health Fair + Pedometer</arm_group_label>
    <arm_group_label>Health Fair, Pedometer + Text Messaging</arm_group_label>
    <arm_group_label>Health Fair, Pedometer, Social Network Support</arm_group_label>
    <arm_group_label>Health Fair, Pedometer, Text Msg, Social Network Support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text Messaging</intervention_name>
    <description>Daily healthy living advice and encouraging messages about walking through text messages</description>
    <arm_group_label>Health Fair, Pedometer + Text Messaging</arm_group_label>
    <arm_group_label>Health Fair, Pedometer, Text Msg, Social Network Support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Social Network Support</intervention_name>
    <description>Family or friends will provide encouragement and remind participants to maintain in a healthy lifestyle and increase daily walking activities</description>
    <arm_group_label>Health Fair, Pedometer, Social Network Support</arm_group_label>
    <arm_group_label>Health Fair, Pedometer, Text Msg, Social Network Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Over 21 years of age&#xD;
&#xD;
          -  Planning on remaining in NYC for at least 7 months&#xD;
&#xD;
          -  Licensed taxi driver for at least three months&#xD;
&#xD;
          -  Speaks English, Bengali, Hindi, Spanish or French&#xD;
&#xD;
          -  Currently owns a cell phone, uses text messaging services and is willing to accept&#xD;
             text messages for this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Part-time driver (fewer than 5 shifts/week, totaling less than 35 hours per week)&#xD;
&#xD;
          -  History of any CVD or any other medical conditions (e.g. severe osteoarthritis) that&#xD;
             will prevent him from walking&#xD;
&#xD;
               -  Please note: All inclusion/exclusion criteria are based upon self reported&#xD;
                  information captured during study screening procedures.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesca Gany, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pedometer</keyword>
  <keyword>walking</keyword>
  <keyword>taxi driver</keyword>
  <keyword>16-1659</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03010163/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03010163
org study id: 16-1659
nct id: NCT03010163
lead sponsor: 
This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC taxi
      garage bases and airport taxi holding lots and pedometers. Group 2 includes Health Fairs,
      pedometers and text messaging to facilitate walking and living a healthier lifestyle. Group 3
      includes Health Fairs, pedometers and social network support. Group 4 includes Health Fairs,
      pedometers, text messaging and social network support.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Increase average daily step counts
time frame: 6 months post randomization
description: Increase average step counts per day
arm group label: Health Fair + Pedometer
arm group type: Active Comparator
description: Participants will get free weight, height, waist, and blood pressure testing at health fairs stationed at NYC taxi garage bases and airport taxi holding lots. Health fair staff will follow up with participants who need to see a doctor due to a high blood pressure reading or other unusual result that needs a physician follow-up. All participants will be given a pedometer with instructions on how to use it to track their daily step counts. Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.
arm group label: Health Fair, Pedometer + Text Messaging
arm group type: Experimental
description: In addition to the health fair services with general follow-up, and giving each driver a pedometer with instructions on how to use the devise to track daily step counts, all participants in this group will receive daily healthy living advice and encouraging messages about walking through text messages sent by study staff to participants' cellular phone. Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.
arm group label: Health Fair, Pedometer, Social Network Support
arm group type: Experimental
description: Each participant in this group will receive the health fair services with general follow-up along with a pedometer with instructions on how to use the device to track daily step counts. Additionally, participants in this group will be asked to provide the names of family or friends who will form a social support network team. This team will provide encouragement and remind participants to maintain a healthy lifestyle and increase daily walking activities. Participants will be given a social network guide to train their family and/or friends on how to best motivate the participants . Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.
arm group label: Health Fair, Pedometer, Text Msg, Social Network Support
arm group type: Experimental
description: Participants in this group will receive the health fair service with general follow-up, along with a pedometer with instructions on how to use the device to track daily step counts. Participants will also receive daily healthy living advice through encouraging text messages about walking through text messages sent by our staff to participants' cellular phones. Participants will also be asked to provide the names of family or friends who will form a social support network team. This team will provide encouragement and remind participants to maintain a healthy lifestyle and increase daily walking activities. Participants will be given tools to train their family and/or friends on how to best motivate the drivers. Participants will be randomized by envelope provided by Memorial Sloan Kettering's Department of Epidemiology and Biostatistics during an in person meeting after the completion of the 1 month run-in or by phone in case we are unable to meet them in person.
intervention type: Other
intervention name: Health Fair
description: Testing includes weight, height, waist and blood pressure testing. In the event that the participants are unable to meet in person for health measurements, the staff will accept self-reported measurements over the phone.
arm group label: Health Fair + Pedometer
arm group label: Health Fair, Pedometer + Text Messaging
arm group label: Health Fair, Pedometer, Social Network Support
arm group label: Health Fair, Pedometer, Text Msg, Social Network Support
intervention type: Other
intervention name: Pedometer
description: The Fitbit One/Alta/Inspire wireless tracking pedometers measures steps taken, calories burned, distance traveled and sleep pattern. The Fitbit Alta/Inspire also sends reminders to move, which are notifications that remind the wearer to walk at least 250 steps each hour. If the wearer has not walked 250 steps within the hour, the device will vibrate and send an on-screen reminder 10 minutes before the hour. The reminders to move will be turned off during baseline and will be turned on at randomization for all participants.
arm group label: Health Fair + Pedometer
arm group label: Health Fair, Pedometer + Text Messaging
arm group label: Health Fair, Pedometer, Social Network Support
arm group label: Health Fair, Pedometer, Text Msg, Social Network Support
intervention type: Other
intervention name: Text Messaging
description: Daily healthy living advice and encouraging messages about walking through text messages
arm group label: Health Fair, Pedometer + Text Messaging
arm group label: Health Fair, Pedometer, Text Msg, Social Network Support
intervention type: Other
intervention name: Social Network Support
description: Family or friends will provide encouragement and remind participants to maintain in a healthy lifestyle and increase daily walking activities
arm group label: Health Fair, Pedometer, Social Network Support
arm group label: Health Fair, Pedometer, Text Msg, Social Network Support
criteria: 
gender: Male
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Francesca Gany, MD, MS
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
provided document: 