<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/NCT03264248</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16110460</org_study_id>
    <nct_id>NCT03264248</nct_id>
  </id_info>
  <brief_title>Daily Weight Feedback for Wheelchair Users to Promote Weight Loss</brief_title>
  <official_title>Daily Self-weighing Feedback for Wheelchair Users to Promote Weight Loss Through Use of the E-scale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonathan Pearlman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Paralyzed Veterans of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of the proposed study are to test the usability, feasibility and preliminary&#xD;
      efficacy of the E-Scale with wheelchair users. The E-scale was developed as a weight&#xD;
      monitoring technology for wheelchair users. Up to fifteen overweight or obese wheelchair&#xD;
      users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT)&#xD;
      for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g.,&#xD;
      goal setting, self-monitoring) to support lifestyle changes specifically for people with&#xD;
      mobility impairments. The subjects will also be provided the E-scale to track their weight&#xD;
      daily. The outcome measure include usefulness (subjective feedback from a survey about the&#xD;
      program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and&#xD;
      efficacy (improvements in weight and other measures of health) of the weight loss program&#xD;
      coupled with the E-scale at the end of 13 weeks. The primary hypothesis is that the E-scale&#xD;
      coupled with the weight loss intervention will result in significant improvements in weight,&#xD;
      abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression&#xD;
      Scale (CES-D).The results may inform the refinement of this technology to increase its&#xD;
      applicability for wheelchair users to independently monitor their weight in their own homes&#xD;
      while attempting to lose weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wheelchair users have about twice the prevalence of obesity than the general population.&#xD;
      There is also very little or no technology to which they have access to measure their weight&#xD;
      frequently in their homes. Research however, has shown that monitoring your body weight&#xD;
      frequently (i.e. daily) yields significantly better weight loss and weight maintenance&#xD;
      results. This research has never included wheelchair users because they have not had access&#xD;
      to technology to be able to measure their weight daily. The E-scale was developed as a weight&#xD;
      monitoring technology for wheelchair users and has been tested for precision and accuracy in&#xD;
      the laboratory. The goal of this study is to determine the usefulness, feasibility and&#xD;
      efficacy of the E-scale system coupled with a standardized behavioral treatment weight-loss&#xD;
      intervention for overweight or obese wheelchair users.&#xD;
&#xD;
      Up to fifteen overweight or obese wheelchair users will be enrolled in a 13 week study that&#xD;
      includes standard behavioral treatment (SBT) for weight loss, which focuses on diet, physical&#xD;
      activity, and behavioral strategies (e.g., goal setting, self-monitoring) to support&#xD;
      lifestyle changes specifically for people with mobility impairments. The subjects will also&#xD;
      be provided the E-scale to track their weight daily. The outcome measure include usefulness&#xD;
      (subjective feedback from a survey about the program/E-scale), feasibility (accuracy and&#xD;
      repeatable measurements from the E-scale) and efficacy (improvements in weight and other&#xD;
      measures of health) of the weight loss program coupled with the E-scale at the end of 13&#xD;
      weeks.&#xD;
&#xD;
      Study hypotheses are:&#xD;
&#xD;
      Hypothesis 1: The E-scale will be useful based on self-reported feedback from wheelchair&#xD;
      users by more than 50% stating that the E-scale is easy to use, their preferred weight&#xD;
      monitoring system, them feeling that they would use the E-scale if it was available for them&#xD;
      to purchase.&#xD;
&#xD;
      Hypothesis 2: The E-scale will be feasible by providing accurate (+/- 2 lbs. from a&#xD;
      calibrated scale measurement) and repeatable (&lt;3lbs difference from day-to-day) weight&#xD;
      measurements and by the wheelchair users continuing to use the scale more than 70% of the&#xD;
      days of the study.&#xD;
&#xD;
      Hypothesis 3: The E-scale coupled with the weight loss intervention will demonstrate efficacy&#xD;
      by wheelchair users having significant improvements in weight, abdominal girth, body fat&#xD;
      percentage, and the Center for Epidemiologic Studies Depression Scale (CES-D).&#xD;
&#xD;
      This research will determine whether wheelchair users find the E-scale to be useful and&#xD;
      feasible as a way to monitor their weight in their homes. It will also show whether&#xD;
      wheelchair users, like the general population, have better weight loss outcomes when they&#xD;
      monitor their weight daily. This could lead to refinement of the E-scale and a push for more&#xD;
      available technology for wheelchair users to monitor their weight at home which could in turn&#xD;
      lead to a decrease in the prevalence of obesity among wheelchair users.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">February 9, 2018</completion_date>
  <primary_completion_date type="Actual">February 5, 2018</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>Weight Change</measure>
    <time_frame>baseline and 13 weeks</time_frame>
    <description>Change in body weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abdominal Girth Change</measure>
    <time_frame>baseline and 13 weeks</time_frame>
    <description>Change in abdominal girth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body-fat Percentage Change</measure>
    <time_frame>13 weeks</time_frame>
    <description>Change in body fat percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Score at Baseline</measure>
    <time_frame>Baseline only</time_frame>
    <description>Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>E-Scale</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>E-Scale</intervention_name>
    <description>Daily bodyweight system used under legs of bed</description>
    <arm_group_label>E-Scale</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Use Wheelchair as primary means of mobility&#xD;
&#xD;
          -  Uses a bed with 4 legs&#xD;
&#xD;
          -  Body mass index (BMI) ≥27 and ≤40.0&#xD;
&#xD;
          -  Has daily access to Internet&#xD;
&#xD;
          -  Currently owns or willing to use an android device&#xD;
&#xD;
          -  Provides physician clearance to participate in a weight loss intervention&#xD;
&#xD;
          -  Speaks English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an unstable condition requiring physician-supervised diet and exercise&#xD;
             (e.g., diabetes, recent myocardial infarction)&#xD;
&#xD;
          -  Presence of condition precluding engagement in exercise at moderate intensity (e.g.,&#xD;
             asthma, congestive heart failure, etc.)&#xD;
&#xD;
          -  Pregnancy or intention to become pregnant during study&#xD;
&#xD;
          -  Currently being treated for any psychological issues or problems, taking any&#xD;
             psychotropic medications, or receiving treatment with psychotropic medications within&#xD;
             the previous 6 months&#xD;
&#xD;
          -  Reported alcohol intake &gt; 4 drinks/day&#xD;
&#xD;
          -  Reported participation in a formal weight loss program, loss of ≥5% weight in the past&#xD;
             6 months, or current use of weight loss medication.&#xD;
&#xD;
          -  History of bariatric surgery (lap-band, gastric bypass, etc.)&#xD;
&#xD;
          -  Planned extended vacations, absences, or relocation during study&#xD;
&#xD;
          -  A score ≥20 on the Center for Epidemiologic Studies Depression Scale (CES-D)&#xD;
&#xD;
          -  A classification of Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder on the&#xD;
             Eating Disorder Diagnosis Scale (EDDS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon Pearlman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>March 3, 2019</results_first_submitted>
  <results_first_submitted_qc>May 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 21, 2019</results_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Jonathan Pearlman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>overweight</keyword>
  <keyword>wheelchair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Portions of the data may be made available upon request</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03264248/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <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>June 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03264248/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>E-Scale</title>
          <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>E-Scale</title>
          <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.8" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial Weight</title>
          <units>lbs.</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="196.0" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.6" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial Abdominal Girth</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.1" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial Body Fat Percentage</title>
          <units>percentage fat</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.3" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Center for Epidemiologic Studies Scale</title>
          <description>Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Rated Abilities for Health Practices Scale</title>
          <description>Items are rated from 0 to 4. Total scores range from 0-112. Higher scores indicate greater self-efficacy for health practices</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90.6" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Weight Change</title>
        <description>Change in body weight</description>
        <time_frame>baseline and 13 weeks</time_frame>
        <population>Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.</population>
        <group_list>
          <group group_id="O1">
            <title>E-Scale</title>
            <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change</title>
          <description>Change in body weight</description>
          <population>Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.0" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192.8" spread="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Abdominal Girth Change</title>
        <description>Change in abdominal girth</description>
        <time_frame>baseline and 13 weeks</time_frame>
        <population>Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.</population>
        <group_list>
          <group group_id="O1">
            <title>E-Scale</title>
            <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
          </group>
        </group_list>
        <measure>
          <title>Abdominal Girth Change</title>
          <description>Change in abdominal girth</description>
          <population>Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.</population>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.1" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body-fat Percentage Change</title>
        <description>Change in body fat percentage</description>
        <time_frame>13 weeks</time_frame>
        <population>Subject #7 only used the scale twice during the study therefore change in body fat percentage was not able to be calculated. Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.</population>
        <group_list>
          <group group_id="O1">
            <title>E-Scale</title>
            <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
          </group>
        </group_list>
        <measure>
          <title>Body-fat Percentage Change</title>
          <description>Change in body fat percentage</description>
          <population>Subject #7 only used the scale twice during the study therefore change in body fat percentage was not able to be calculated. Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.</population>
          <units>percentage of pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Score at Baseline</title>
        <description>Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology</description>
        <time_frame>Baseline only</time_frame>
        <population>Outcome was only measured during baseline as a screening measurement, subjects were not eligible with a CES-D of &gt; 20. Since there is only one group, this outcome variables was calculated using the CES-D scoring chart.</population>
        <group_list>
          <group group_id="O1">
            <title>E-Scale</title>
            <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Score at Baseline</title>
          <description>Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology</description>
          <population>Outcome was only measured during baseline as a screening measurement, subjects were not eligible with a CES-D of &gt; 20. Since there is only one group, this outcome variables was calculated using the CES-D scoring chart.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not collected for this study</time_frame>
      <desc>Not collected for this study</desc>
      <group_list>
        <group group_id="E1">
          <title>E-Scale</title>
          <description>E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users&#xD;
E-Scale: Daily bodyweight system used under legs of bed</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jonathan Pearlman</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-822-3685</phone>
      <email>jlp46@pitt.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03264248
org study id: PRO16110460
nct id: NCT03264248
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The goals of the proposed study are to test the usability, feasibility and preliminary
      efficacy of the E-Scale with wheelchair users. The E-scale was developed as a weight
      monitoring technology for wheelchair users. Up to fifteen overweight or obese wheelchair
      users will be enrolled in a 13 week study that includes standard behavioral treatment (SBT)
      for weight loss, which focuses on diet, physical activity, and behavioral strategies (e.g.,
      goal setting, self-monitoring) to support lifestyle changes specifically for people with
      mobility impairments. The subjects will also be provided the E-scale to track their weight
      daily. The outcome measure include usefulness (subjective feedback from a survey about the
      program/E-scale), feasibility (accuracy and repeatable measurements from the E-scale) and
      efficacy (improvements in weight and other measures of health) of the weight loss program
      coupled with the E-scale at the end of 13 weeks. The primary hypothesis is that the E-scale
      coupled with the weight loss intervention will result in significant improvements in weight,
      abdominal girth, body fat percentage, and the Center for Epidemiologic Studies Depression
      Scale (CES-D).The results may inform the refinement of this technology to increase its
      applicability for wheelchair users to independently monitor their weight in their own homes
      while attempting to lose weight.
Wheelchair users have about twice the prevalence of obesity than the general population.
      There is also very little or no technology to which they have access to measure their weight
      frequently in their homes. Research however, has shown that monitoring your body weight
      frequently (i.e. daily) yields significantly better weight loss and weight maintenance
      results. This research has never included wheelchair users because they have not had access
      to technology to be able to measure their weight daily. The E-scale was developed as a weight
      monitoring technology for wheelchair users and has been tested for precision and accuracy in
      the laboratory. The goal of this study is to determine the usefulness, feasibility and
      efficacy of the E-scale system coupled with a standardized behavioral treatment weight-loss
      intervention for overweight or obese wheelchair users.

      Up to fifteen overweight or obese wheelchair users will be enrolled in a 13 week study that
      includes standard behavioral treatment (SBT) for weight loss, which focuses on diet, physical
      activity, and behavioral strategies (e.g., goal setting, self-monitoring) to support
      lifestyle changes specifically for people with mobility impairments. The subjects will also
      be provided the E-scale to track their weight daily. The outcome measure include usefulness
      (subjective feedback from a survey about the program/E-scale), feasibility (accuracy and
      repeatable measurements from the E-scale) and efficacy (improvements in weight and other
      measures of health) of the weight loss program coupled with the E-scale at the end of 13
      weeks.

      Study hypotheses are:

      Hypothesis 1: The E-scale will be useful based on self-reported feedback from wheelchair
      users by more than 50% stating that the E-scale is easy to use, their preferred weight
      monitoring system, them feeling that they would use the E-scale if it was available for them
      to purchase.

      Hypothesis 2: The E-scale will be feasible by providing accurate (+/- 2 lbs. from a
      calibrated scale measurement) and repeatable (<3lbs difference from day-to-day) weight
      measurements and by the wheelchair users continuing to use the scale more than 70% of the
      days of the study.

      Hypothesis 3: The E-scale coupled with the weight loss intervention will demonstrate efficacy
      by wheelchair users having significant improvements in weight, abdominal girth, body fat
      percentage, and the Center for Epidemiologic Studies Depression Scale (CES-D).

      This research will determine whether wheelchair users find the E-scale to be useful and
      feasible as a way to monitor their weight in their homes. It will also show whether
      wheelchair users, like the general population, have better weight loss outcomes when they
      monitor their weight daily. This could lead to refinement of the E-scale and a push for more
      available technology for wheelchair users to monitor their weight at home which could in turn
      lead to a decrease in the prevalence of obesity among wheelchair users.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Change
time frame: baseline and 13 weeks
description: Change in body weight
measure: Abdominal Girth Change
time frame: baseline and 13 weeks
description: Change in abdominal girth
measure: Body-fat Percentage Change
time frame: 13 weeks
description: Change in body fat percentage
measure: Depression Score at Baseline
time frame: Baseline only
description: Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology
arm group label: E-Scale
arm group type: Experimental
description: E-scale daily bodyweight system coupled with a standardized behavioral treatment weight-loss intervention for overweight or obese wheelchair users
intervention type: Device
intervention name: E-Scale
description: Daily bodyweight system used under legs of bed
arm group label: E-Scale
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jon Pearlman, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Jonathan Pearlman
investigator title: Associate Professor
mesh term: Overweight
mesh term: Weight Loss
sharing ipd: No
ipd description: Portions of the data may be made available upon request
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 