<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/NCT02188875</url>
  </required_header>
  <id_info>
    <org_study_id>130024</org_study_id>
    <nct_id>NCT02188875</nct_id>
  </id_info>
  <brief_title>Fitbit One and Text Messaging Prompts to Promote Physical Activity in Overweight/Obese Adults</brief_title>
  <acronym>TXT2BFIT</acronym>
  <official_title>Wearable Sensor/Device With Website (Fitbit One) and SMS Text Messaging Prompts to Increase Physical Activity in Overweight/Obese Adults: A Randomized Controlled Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carol Vassiliadis Family</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies suggest self-regulatory techniques including self-monitoring, and SMS&#xD;
      text-messaging as an intervention modality, can modify health behaviors including physical&#xD;
      activity (PA). The primary purpose of this study was to examine change in objectively&#xD;
      measured PA in a randomized controlled pilot trial that tested a wearable sensor/device&#xD;
      (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in&#xD;
      overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One&#xD;
      and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided&#xD;
      to facilitate self-monitoring with a wearable tracker for instant feedback and website of&#xD;
      daily PA summaries. Outcome measures were number of steps and minutes of PA by&#xD;
      intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week&#xD;
      follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that&#xD;
      text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA&#xD;
      compared to only the Fitbit One at 6-week follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>steps per day (Actigraph GT3X+)</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minutes per week of physical activity by intensity level (Actigraph GT3X+)</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Moderate-to-vigorous intensity physical activity (MVPA) (min/wk) and total PA (min/wk) were assessed using Actigraph GT3X+ at baseline week and 6-week follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical activity levels (Fitbit One)</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Physical activity by intensity level (i.e., fairly and very active minutes and total active minutes) were assessed using the Fitbit One throughout the entire duration of the study</description>
  </other_outcome>
  <other_outcome>
    <measure>Steps per a day (Fitbit One)</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Steps per day were assessed using the Fitbit One throughout the entire duration of the study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Health Behavior</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>SMS Text Messages &amp; Fitbit One</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All study participants were provided a Fitbit One to facilitate self-monitoring of PA. Those who were randomly assigned to the intervention group were asked to indicate 3 preferred times of the day to receive text message prompts to do PA throughout the 6-week study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fitbit One Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS Text Messages &amp; Fitbit One</intervention_name>
    <description>The primary aim was to test text-messaging in its basic form to prompt physical activity. A secondary aim was to examine the effects of the Fitbit One.</description>
    <arm_group_label>SMS Text Messages &amp; Fitbit One</arm_group_label>
    <other_name>Fitbit One</other_name>
    <other_name>SMS text-messaging</other_name>
    <other_name>SMS text-messages</other_name>
    <other_name>wearable sensor</other_name>
    <other_name>wearable device</other_name>
    <other_name>text message reminders</other_name>
    <other_name>text message prompts</other_name>
    <other_name>Actigraph GT3X+</other_name>
    <other_name>self-monitoring</other_name>
    <other_name>self-regulation</other_name>
    <other_name>physical activity</other_name>
    <other_name>website</other_name>
    <other_name>tracker</other_name>
    <other_name>mobile application</other_name>
    <other_name>mobile app</other_name>
    <other_name>MVPA</other_name>
    <other_name>fairly active minutes</other_name>
    <other_name>very active minutes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fitbit One Only</intervention_name>
    <description>Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)</description>
    <arm_group_label>Fitbit One Only</arm_group_label>
    <other_name>Fitbit One</other_name>
    <other_name>wearable sensor</other_name>
    <other_name>wearable device</other_name>
    <other_name>text message reminders</other_name>
    <other_name>text message prompts</other_name>
    <other_name>Actigraph GT3X+</other_name>
    <other_name>self-monitoring</other_name>
    <other_name>self-regulation</other_name>
    <other_name>physical activity</other_name>
    <other_name>website</other_name>
    <other_name>tracker</other_name>
    <other_name>mobile application</other_name>
    <other_name>mobile app</other_name>
    <other_name>MVPA</other_name>
    <other_name>fairly active minutes</other_name>
    <other_name>very active minutes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-69 years of age&#xD;
&#xD;
          -  overweight or obese (otherwise healthy)&#xD;
&#xD;
          -  does not meet recommended levels of PA (&gt;150 min/wk of MVPA)&#xD;
&#xD;
          -  owns a personal mobile phone and able to use SMS text-messaging&#xD;
&#xD;
          -  owns a personal computer, has access to Internet, able to operate the Fitbit One&#xD;
&#xD;
          -  fluent in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie Wang, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Pierce, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://online.liebertpub.com/doi/abs/10.1089/tmj.2014.0176</url>
    <description>published manuscript of primary study results</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fitbit One</keyword>
  <keyword>wearable sensor</keyword>
  <keyword>wearable device</keyword>
  <keyword>web-based intervention</keyword>
  <keyword>SMS text messages</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>physical activity</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>text message prompts</keyword>
  <keyword>text messaging</keyword>
  <keyword>technology</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02188875
org study id: 130024
nct id: NCT02188875
lead sponsor: 
collaborator: 
has dmc: No
Previous studies suggest self-regulatory techniques including self-monitoring, and SMS
      text-messaging as an intervention modality, can modify health behaviors including physical
      activity (PA). The primary purpose of this study was to examine change in objectively
      measured PA in a randomized controlled pilot trial that tested a wearable sensor/device
      (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in
      overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One
      and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided
      to facilitate self-monitoring with a wearable tracker for instant feedback and website of
      daily PA summaries. Outcome measures were number of steps and minutes of PA by
      intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week
      follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that
      text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA
      compared to only the Fitbit One at 6-week follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: steps per day (Actigraph GT3X+)
time frame: up to 6 weeks
description: Number of steps per day was measured using Actigraph GT3X+ at baseline and 6-week follow-up
measure: Minutes per week of physical activity by intensity level (Actigraph GT3X+)
time frame: up to 6 weeks
description: Moderate-to-vigorous intensity physical activity (MVPA) (min/wk) and total PA (min/wk) were assessed using Actigraph GT3X+ at baseline week and 6-week follow-up
measure: Physical activity levels (Fitbit One)
time frame: up to 6 weeks
description: Physical activity by intensity level (i.e., fairly and very active minutes and total active minutes) were assessed using the Fitbit One throughout the entire duration of the study
measure: Steps per a day (Fitbit One)
time frame: up to 6 weeks
description: Steps per day were assessed using the Fitbit One throughout the entire duration of the study
arm group label: SMS Text Messages & Fitbit One
arm group type: Experimental
description: All study participants were provided a Fitbit One to facilitate self-monitoring of PA. Those who were randomly assigned to the intervention group were asked to indicate 3 preferred times of the day to receive text message prompts to do PA throughout the 6-week study period.
arm group label: Fitbit One Only
arm group type: Active Comparator
description: An active control group was also provided the Fitbit One to facilitate self-monitoring of PA throughout the 6-week study period.
intervention type: Behavioral
intervention name: SMS Text Messages & Fitbit One
description: The primary aim was to test text-messaging in its basic form to prompt physical activity. A secondary aim was to examine the effects of the Fitbit One.
arm group label: SMS Text Messages & Fitbit One
other name: Fitbit One
other name: SMS text-messaging
other name: SMS text-messages
other name: wearable sensor
other name: wearable device
other name: text message reminders
other name: text message prompts
other name: Actigraph GT3X+
other name: self-monitoring
other name: self-regulation
other name: physical activity
other name: website
other name: tracker
other name: mobile application
other name: mobile app
other name: MVPA
other name: fairly active minutes
other name: very active minutes
intervention type: Behavioral
intervention name: Fitbit One Only
description: Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)
arm group label: Fitbit One Only
other name: Fitbit One
other name: wearable sensor
other name: wearable device
other name: text message reminders
other name: text message prompts
other name: Actigraph GT3X+
other name: self-monitoring
other name: self-regulation
other name: physical activity
other name: website
other name: tracker
other name: mobile application
other name: mobile app
other name: MVPA
other name: fairly active minutes
other name: very active minutes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julie Wang, PhD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
last name: John Pierce, PhD
role: Study Chair
affiliation: University of California, San Diego
facility: 
country: United States
url: http://online.liebertpub.com/doi/abs/10.1089/tmj.2014.0176
description: published manuscript of primary study results
responsible party type: Sponsor
mesh term: Overweight