<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/NCT02265432</url>
  </required_header>
  <id_info>
    <org_study_id>R -608-000-071-112</org_study_id>
    <nct_id>NCT02265432</nct_id>
  </id_info>
  <brief_title>Using Mobile Technology to Promote Physical Activity</brief_title>
  <official_title>iFit-Study: Using Mobile Technology to Promote Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Falk Mueller-Riemenschneider</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Singapore</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to test an intervention which uses a personalized&#xD;
      mobile-technology based approach that aims to promote physical activity and reduce sedentary&#xD;
      behaviour in inactive working Singaporean adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Considering the increasing burden in type 2 diabetes mellitus and other chronic diseases, the&#xD;
      promotion of physical activity and reduction of sedentary behavior have an important role to&#xD;
      improve population health.&#xD;
&#xD;
      Primarily, potential participants will be identified and recruited among participants from&#xD;
      the Singapore Health Study (SHS) 2014 based on pre-specified selection criteria . SHS is a&#xD;
      cross-sectional study of adults between 18 and 79 years which is conducted annually to&#xD;
      monitor health, health behavior and health determinants among the Singapore general&#xD;
      population.&#xD;
&#xD;
      All eligible participants will be randomized with a 1:1 ratio to intervention and control&#xD;
      group.&#xD;
&#xD;
      Intervention group participants will receive a personalized mobile-technology based&#xD;
      intervention to promote physical activity. It consists of four components:&#xD;
&#xD;
        1. General physical activity educational materials&#xD;
&#xD;
        2. Wearable activity tracking devices to enable the intervention participants to&#xD;
           self-monitor their physical activity behavior and receive real-time feedback&#xD;
&#xD;
        3. Access to an online map of Singapore providing location based information about leisure&#xD;
           time physical activity opportunities&#xD;
&#xD;
        4. Personalized text messages which include, educational information, tailored theory-based&#xD;
           motivational messages, as well as compliance enhancing reminders&#xD;
&#xD;
      Control group participants will receive general physical activity educational materials,&#xD;
      identical in content to that of the general educational materials of intervention group&#xD;
      participants.&#xD;
&#xD;
      All participants will be assessed at baseline, 6 months and 12 months after the intervention&#xD;
      by accelerometry and self-reported questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</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>average daily step counts</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>time spent in minutes per week on moderate- to vigorous- intensity physical activity measured by accelerometer</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time spent in sedentary activities per day</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of physical activity(measured by accelerometer and self-report) determined in MET minutes per week</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time spent in vigorous-, moderate- and light- intensity activities will be determined.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>proportion of participants being physical active according to current recommendations (at least 150 minutes of moderate intensity activity or an appropriate equivalent of vigorous activity)</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Recall, use and perceived usefulness of intervention and intervention components</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Knowledge, attitudes and perceived barriers to physical activity</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Mobile technology intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>General physical activity educational materials&#xD;
Wearable activity tracking devices to enable the intervention participants to self-monitor their physical activity behavior and receive real-time feedback&#xD;
Access to an online map of Singapore providing location based information about leisure time physical activity opportunities&#xD;
Personalized text messages which include, educational information, tailored theory-based motivational messages, as well as compliance enhancing reminders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>1.General physical activity educational materials</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General physical activity educational materials</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Mobile technology intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wearable activity tracking devices (fitbit)</intervention_name>
    <arm_group_label>Mobile technology intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>online map</intervention_name>
    <arm_group_label>Mobile technology intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized text messages</intervention_name>
    <arm_group_label>Mobile technology intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women 25 to 65 years of age&#xD;
&#xD;
          -  Physically inactive&#xD;
&#xD;
          -  Working full-time for at least one more year after inclusion&#xD;
&#xD;
          -  Signed written informed consent for the intervention study&#xD;
&#xD;
          -  Willing to wear the activity tracker, fitbit all the time every day for 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe medical conditions prohibiting participation in physical activity&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  insufficient English language skills&#xD;
&#xD;
          -  Participants who have already activity tracker device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Falk Mueller-Riemenschneider Falk &lt;falk.mueller-riemenschneider, MSc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saw Swee Hock School of Public Health, National University of Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Falk Mueller-Riemenschneider Falk &lt;falk.mueller-riemenschneider, MBBS,MSc,MD</last_name>
    <phone>+65 66013122</phone>
    <email>falk.mueller-riemenschneider@nuhs.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Univeristy of Singapore</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2014</study_first_posted>
  <last_update_submitted>November 12, 2015</last_update_submitted>
  <last_update_submitted_qc>November 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>Dr Falk Mueller-Riemenschneider</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Sedentary behavior</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/NCT02265432
org study id: R -608-000-071-112
nct id: NCT02265432
lead sponsor: 
The purpose of this study is to test an intervention which uses a personalized
      mobile-technology based approach that aims to promote physical activity and reduce sedentary
      behaviour in inactive working Singaporean adults.
Considering the increasing burden in type 2 diabetes mellitus and other chronic diseases, the
      promotion of physical activity and reduction of sedentary behavior have an important role to
      improve population health.

      Primarily, potential participants will be identified and recruited among participants from
      the Singapore Health Study (SHS) 2014 based on pre-specified selection criteria . SHS is a
      cross-sectional study of adults between 18 and 79 years which is conducted annually to
      monitor health, health behavior and health determinants among the Singapore general
      population.

      All eligible participants will be randomized with a 1:1 ratio to intervention and control
      group.

      Intervention group participants will receive a personalized mobile-technology based
      intervention to promote physical activity. It consists of four components:

        1. General physical activity educational materials

        2. Wearable activity tracking devices to enable the intervention participants to
           self-monitor their physical activity behavior and receive real-time feedback

        3. Access to an online map of Singapore providing location based information about leisure
           time physical activity opportunities

        4. Personalized text messages which include, educational information, tailored theory-based
           motivational messages, as well as compliance enhancing reminders

      Control group participants will receive general physical activity educational materials,
      identical in content to that of the general educational materials of intervention group
      participants.

      All participants will be assessed at baseline, 6 months and 12 months after the intervention
      by accelerometry and self-reported questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: average daily step counts
time frame: 6 months
measure: time spent in minutes per week on moderate- to vigorous- intensity physical activity measured by accelerometer
time frame: 6 months
measure: time spent in sedentary activities per day
time frame: 6 months
measure: level of physical activity(measured by accelerometer and self-report) determined in MET minutes per week
time frame: 6 months
measure: time spent in vigorous-, moderate- and light- intensity activities will be determined.
time frame: 6 months
measure: proportion of participants being physical active according to current recommendations (at least 150 minutes of moderate intensity activity or an appropriate equivalent of vigorous activity)
time frame: 6 months
measure: Recall, use and perceived usefulness of intervention and intervention components
time frame: 6 months
measure: Knowledge, attitudes and perceived barriers to physical activity
time frame: 6 months
measure: Quality of life
time frame: 6 months
arm group label: Mobile technology intervention
arm group type: Experimental
description: General physical activity educational materials
Wearable activity tracking devices to enable the intervention participants to self-monitor their physical activity behavior and receive real-time feedback
Access to an online map of Singapore providing location based information about leisure time physical activity opportunities
Personalized text messages which include, educational information, tailored theory-based motivational messages, as well as compliance enhancing reminders
arm group label: Control
arm group type: Other
description: 1.General physical activity educational materials
intervention type: Behavioral
intervention name: General physical activity educational materials
arm group label: Control
arm group label: Mobile technology intervention
intervention type: Device
intervention name: Wearable activity tracking devices (fitbit)
arm group label: Mobile technology intervention
intervention type: Other
intervention name: online map
arm group label: Mobile technology intervention
intervention type: Other
intervention name: Personalized text messages
arm group label: Mobile technology intervention
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Falk Mueller-Riemenschneider Falk <falk.mueller-riemenschneider, MSc, MD
role: Principal Investigator
affiliation: Saw Swee Hock School of Public Health, National University of Singapore
last name: Falk Mueller-Riemenschneider Falk <falk.mueller-riemenschneider, MBBS,MSc,MD
phone: +65 66013122
email: falk.mueller-riemenschneider@nuhs.edu.sg
facility: 
status: Recruiting
country: Singapore
responsible party type: Sponsor-Investigator
investigator affiliation: National University of Singapore
investigator full name: Dr Falk Mueller-Riemenschneider
investigator title: Assistant Professor