<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/NCT03839082</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00153750</org_study_id>
    <nct_id>NCT03839082</nct_id>
  </id_info>
  <brief_title>Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease</brief_title>
  <official_title>A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Association for the Study of Liver Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at physical activity and nutrition in patients with non-alcoholic fatty&#xD;
      liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if&#xD;
      providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as&#xD;
      an addition to their usual clinical care helps them to lose weight and improve liver-related&#xD;
      parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">February 26, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score</measure>
    <time_frame>Baseline, 6 months,</time_frame>
    <description>CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat).&#xD;
Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP&#xD;
12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Body Weight</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500.&#xD;
Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active.&#xD;
Insufficient paired results existed to provide percent change measurements. Medians overall are provided.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <condition>Non-alcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Usual Care then FitBit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is the waitlist control arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FitBit then Usual Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention includes education, physical activity, and a nutrition assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care then FitBit</intervention_name>
    <description>Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).</description>
    <arm_group_label>FitBit then Usual Care</arm_group_label>
    <arm_group_label>Usual Care then FitBit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FitBit then Usual Care</intervention_name>
    <description>Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
    <arm_group_label>FitBit then Usual Care</arm_group_label>
    <arm_group_label>Usual Care then FitBit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic&#xD;
             steatohepatitis (NASH)&#xD;
&#xD;
          -  Access to mobile phone/tablet/ or computer compatible with FitBit application and&#xD;
             ability to use said device and application&#xD;
&#xD;
          -  Ability to participate in physical activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other form of liver disease( Alcohol related liver disease; viral hepatitis,&#xD;
             autoimmune liver disease, hereditary forms of liver disease, etc.)&#xD;
&#xD;
          -  History of decompensated cirrhosis&#xD;
&#xD;
          -  Plans for invasive procedures or other regimented lifestyle programs for weight&#xD;
             reduction&#xD;
&#xD;
          -  Cardiovascular event in the previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Konerman</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>February 25, 2022</results_first_submitted>
  <results_first_submitted_qc>April 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2022</results_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Monica Tincopa</investigator_full_name>
    <investigator_title>Clinical Lecturer in Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Mobile Technology</keyword>
  <keyword>Weight</keyword>
  <keyword>Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>November 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03839082/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Five people withdrew prior to receiving fitbits or first surveys.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FitBit Then Usual Care</title>
          <description>Intervention includes education, physical activity, and a nutrition assessment.&#xD;
Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).&#xD;
FitBit then Usual Care: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care Then FitBit</title>
          <description>This is the waitlist control arm.&#xD;
Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).&#xD;
Once they start FitBit,, Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Initial Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Crossover to Other Arm</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FitBit Then Usual Care</title>
          <description>Intervention includes education, physical activity, and a nutrition assessment.&#xD;
FitBit then Usual Care: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.&#xD;
Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).</description>
        </group>
        <group group_id="B2">
          <title>Usual Care Then FitBit</title>
          <description>This is the waitlist control arm.&#xD;
Usual Care then FitBit: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).&#xD;
Once they start FitBit, intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" lower_limit="44" upper_limit="65"/>
                    <measurement group_id="B2" value="50" lower_limit="41" upper_limit="61"/>
                    <measurement group_id="B3" value="52.5" lower_limit="43" upper_limit="63"/>
                  </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="21"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African-American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </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="33"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="204.78" spread="58.62"/>
                    <measurement group_id="B2" value="204.40" spread="57.54"/>
                    <measurement group_id="B3" value="204.49" spread="57.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.4" lower_limit="28.2" upper_limit="38.6"/>
                    <measurement group_id="B2" value="32.02" lower_limit="28.1" upper_limit="36.5"/>
                    <measurement group_id="B3" value="32.2" lower_limit="28.2" upper_limit="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score</title>
        <description>CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat).&#xD;
Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP&#xD;
12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.</description>
        <time_frame>Baseline, 6 months,</time_frame>
        <population>Due to the disruption caused by the COVID epidemic, follow up was dramatically lower than planned, and values were missing for some individuals in both arms.</population>
        <group_list>
          <group group_id="O1">
            <title>FitBit</title>
            <description>Intervention includes education, physical activity, and a nutrition assessment.&#xD;
FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>This is the waitlist control arm.&#xD;
Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score</title>
          <description>CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat).&#xD;
Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP&#xD;
12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.</description>
          <population>Due to the disruption caused by the COVID epidemic, follow up was dramatically lower than planned, and values were missing for some individuals in both arms.</population>
          <units>percent change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.0"/>
                    <measurement group_id="O2" value="8.7" lower_limit="-3.3" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Body Weight</title>
        <description>Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>Weight data is only available for one individual at both times.</population>
        <group_list>
          <group group_id="O1">
            <title>FitBit</title>
            <description>Intervention includes education, physical activity, and a nutrition assessment.&#xD;
FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>This is the waitlist control arm.&#xD;
Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Body Weight</title>
          <description>Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline</description>
          <population>Weight data is only available for one individual at both times.</population>
          <units>percent change in weight</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Since weight data is only available for 1 individual at both times, it is not represented to honor privacy.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)</title>
        <description>The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500.&#xD;
Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active.&#xD;
Insufficient paired results existed to provide percent change measurements. Medians overall are provided.</description>
        <time_frame>Baseline, 6 months</time_frame>
        <population>Due to COVID 19's impact on participation, data for all participants is not available.</population>
        <group_list>
          <group group_id="O1">
            <title>FitBit</title>
            <description>Intervention includes education, physical activity, and a nutrition assessment.&#xD;
FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>This is the waitlist control arm.&#xD;
Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)</title>
          <description>The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500.&#xD;
Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active.&#xD;
Insufficient paired results existed to provide percent change measurements. Medians overall are provided.</description>
          <population>Due to COVID 19's impact on participation, data for all participants is not available.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" lower_limit="20" upper_limit="60"/>
                    <measurement group_id="O2" value="42.5" lower_limit="30" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" lower_limit="30" upper_limit="60"/>
                    <measurement group_id="O2" value="30" lower_limit="10" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>While in study - up to 1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FitBit</title>
          <description>Intervention includes education, physical activity, and a nutrition assessment.&#xD;
FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).</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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT 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>Monica Tincopa</name_or_title>
      <organization>University of California Los Angeles</organization>
      <phone>310 825-2631</phone>
      <email>mtincopa@mednet.ucla.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/NCT03839082
org study id: HUM00153750
nct id: NCT03839082
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will look at physical activity and nutrition in patients with non-alcoholic fatty
      liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if
      providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as
      an addition to their usual clinical care helps them to lose weight and improve liver-related
      parameters.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
time frame: Baseline, 6 months,
description: CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat).
Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP
12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.
measure: Percent Change in Body Weight
time frame: Baseline, 6 months
description: Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline
measure: Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
time frame: Baseline, 6 months
description: The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500.
Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active.
Insufficient paired results existed to provide percent change measurements. Medians overall are provided.
arm group label: Usual Care then FitBit
arm group type: Active Comparator
description: This is the waitlist control arm.
arm group label: FitBit then Usual Care
arm group type: Experimental
description: Intervention includes education, physical activity, and a nutrition assessment.
intervention type: Other
intervention name: Usual Care then FitBit
description: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
arm group label: FitBit then Usual Care
arm group label: Usual Care then FitBit
intervention type: Other
intervention name: FitBit then Usual Care
description: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
arm group label: FitBit then Usual Care
arm group label: Usual Care then FitBit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Monica Konerman
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Monica Tincopa
investigator title: Clinical Lecturer in Internal Medicine
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 