<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/NCT01688804</url>
  </required_header>
  <id_info>
    <org_study_id>1R03DK095740-01</org_study_id>
    <nct_id>NCT01688804</nct_id>
  </id_info>
  <brief_title>Reducing Sedentary Time in Obese Adults</brief_title>
  <official_title>A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Greater time spent in sedentary behaviors, independent of physical activity level, can&#xD;
      increase risk of morbidity and mortality. Objective assessments indicate that bariatric&#xD;
      surgery patients spend large amounts of time in sedentary behaviors. The present study is the&#xD;
      first to test whether a mobile health (mHealth) approach that employs widely adopted&#xD;
      smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible&#xD;
      and acceptable method of reducing sedentary time in these patients and other obese&#xD;
      populations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average daily sedentary minutes</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average daily adherence to prompts to reduce sedentary time delivered via mobile smartphone</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Sedentary Behavior</condition>
  <arm_group>
    <arm_group_label>Behavioral intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral intervention to reduce sedentary time delivered via mobile smartphone</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral intervention to reduce sedentary time delivered via mobile smartphone</intervention_name>
    <description>The overall goals of the intervention are to decrease overall sedentary time and to increase the number of breaks in sedentary time. The intervention approach combines an advanced smartphone device with an on-board accelerometer and a sophisticated smartphone application to: 1) monitor participants sedentary behavior in real time in their natural environment; and 2) use monitored data to deliver immediate, individually-tailored, goal-driven prompts and feedback to encourage substitute of sedentary behaviors with physical activity.</description>
    <arm_group_label>Behavioral intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bariatric surgery patients and other obese individuals will be considered&#xD;
&#xD;
          -  Body mass index &gt;= 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Report being unable to engage in daily activities and walk continuously for &gt;= 10&#xD;
             minutes without assistance&#xD;
&#xD;
          -  Are currently involved in a physical activity intervention.&#xD;
&#xD;
          -  Are unable to read or understand the study materials&#xD;
&#xD;
          -  Are currently taking medications that cause dizziness and/or feeling faint when&#xD;
             sitting or standing.&#xD;
&#xD;
          -  Report any condition that in the opinion of investigators would preclude adherence to&#xD;
             the intervention protocol including plans to relocate, history of substance abuse or&#xD;
             other significant psychiatric problems, or terminal illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dale S Bond, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital/Brown Alpert Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Weight Control and Diabetes Research Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://projectreporter.nih.gov/project_info_details.cfm?aid=8339603</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.weightresearch.org/fundedgrants.html</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>March 19, 2015</last_update_submitted>
  <last_update_submitted_qc>March 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sedentary behavior</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Obesity</keyword>
  <keyword>Mobile health</keyword>
  <keyword>Smartphone</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/NCT01688804
org study id: 1R03DK095740-01
nct id: NCT01688804
lead sponsor: 
collaborator: 
has dmc: No
Greater time spent in sedentary behaviors, independent of physical activity level, can
      increase risk of morbidity and mortality. Objective assessments indicate that bariatric
      surgery patients spend large amounts of time in sedentary behaviors. The present study is the
      first to test whether a mobile health (mHealth) approach that employs widely adopted
      smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible
      and acceptable method of reducing sedentary time in these patients and other obese
      populations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average daily sedentary minutes
time frame: 4 weeks
measure: Average daily adherence to prompts to reduce sedentary time delivered via mobile smartphone
time frame: 4 weeks
arm group label: Behavioral intervention
arm group type: Experimental
description: Behavioral intervention to reduce sedentary time delivered via mobile smartphone
intervention type: Behavioral
intervention name: Behavioral intervention to reduce sedentary time delivered via mobile smartphone
description: The overall goals of the intervention are to decrease overall sedentary time and to increase the number of breaks in sedentary time. The intervention approach combines an advanced smartphone device with an on-board accelerometer and a sophisticated smartphone application to: 1) monitor participants sedentary behavior in real time in their natural environment; and 2) use monitored data to deliver immediate, individually-tailored, goal-driven prompts and feedback to encourage substitute of sedentary behaviors with physical activity.
arm group label: Behavioral intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dale S Bond, Ph.D.
role: Principal Investigator
affiliation: The Miriam Hospital/Brown Alpert Medical School
facility: 
country: United States
url: http://projectreporter.nih.gov/project_info_details.cfm?aid=8339603
description: Related Info
url: http://www.weightresearch.org/fundedgrants.html
description: Related Info
responsible party type: Sponsor