<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/NCT04486235</url>
  </required_header>
  <id_info>
    <org_study_id>1812006829</org_study_id>
    <nct_id>NCT04486235</nct_id>
  </id_info>
  <brief_title>A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care</brief_title>
  <official_title>A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drexel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drexel University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests the feasibility, acceptability, and preliminary efficacy of using a brief&#xD;
      pamphlet in the primary care waiting room focused on promoting patient-initiated&#xD;
      weight-related discussions in primary care appointments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a chronic and complex disease that many national and professional organizations&#xD;
      recommend be discussed frequently in primary care. However, rates of weight-related&#xD;
      communication in primary care are suboptimal. When patients and physicians communicate about&#xD;
      weight (defined as usage of any the 5As-ask, assess, advise, agree, and/or assist-in a&#xD;
      weight-related conversation), patients are more likely to improve dietary habits, demonstrate&#xD;
      more motivation for health behavior change, attempt weight loss treatment, and lose more&#xD;
      weight as compared to patients who do not engage in weight-related communication with their&#xD;
      physicians. Interventions have attempted to increase the rates of weight-related&#xD;
      communication in primary care. However, they have focused solely on physicians and have only&#xD;
      yielded modest efficacy. Intervention with patients on proposed patient-related barriers may&#xD;
      be key to improving the rate of weight-related communication in primary care. The waiting&#xD;
      room prior to appointments is an underutilized intervention setting. Prior waiting room&#xD;
      interventions have shown promising results for increasing health communication between&#xD;
      patients and physicians. However, no prior study has focused on weight-related communication.&#xD;
      Thus, this study aims to test the feasibility, acceptability, and preliminary efficacy of an&#xD;
      experiential pamphlet delivered in the waiting room targeting patient-related barriers to&#xD;
      weight communication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2019</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>
    <intervention_model_description>Randomization is stratified. On the screening form, participants indicate whether or not they plan to speak with their physician about their weight in their appointment. Randomization is stratified by if if the participant indicates that they plan to speak about weight or not.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The condition of the participant is revealed after the participant completes the consent form and screening questionnaire and is deemed eligible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Acceptability Questionnaire</measure>
    <time_frame>Immediately after appointment (Same day as intervention delivery)</time_frame>
    <description>Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery</measure>
    <time_frame>When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months</time_frame>
    <description>Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark &gt;70%), 2) percentage of eligible participants after screening (benchmark &gt;50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark &lt;20%), 4)percentage of participants who complete the experiential pamphlet (benchmark &gt;80%).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>If Weight Was Spoken About in the Appointment</measure>
    <time_frame>Immediately after appointment (Same day as intervention delivery)</time_frame>
    <description>Participants respond to Yes/No questions about content of their appointment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Obesity</condition>
  <condition>Primary Care</condition>
  <condition>Health Communication</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive experiential pamphlet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No materials, usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief waiting room pamphlet</intervention_name>
    <description>An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Present for an appointment at the Family Medicine Office&#xD;
&#xD;
          -  Indicate that they can speak and read English&#xD;
&#xD;
          -  Indicate that their Shape is &gt; or = 5 on measure (Stunkard, Sørensen, &amp; Schulsinger,&#xD;
             1983)&#xD;
&#xD;
          -  Indicate that they are 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Indicate that they are Pregnant&#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>Jocelyn Remmert, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drexel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Drexel University Family Medicine Office</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>April 25, 2019</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <results_first_submitted>February 25, 2021</results_first_submitted>
  <results_first_submitted_qc>April 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2021</results_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <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>April 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT04486235/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Receive experiential pamphlet&#xD;
Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>No materials, usual care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Analysis</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Receive experiential pamphlet&#xD;
Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>No materials, usual care</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </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="43.1" spread="15.4"/>
                    <measurement group_id="B2" value="38.2" spread="16.02"/>
                    <measurement group_id="B3" value="40.6" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transgender</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment Acceptability Questionnaire</title>
        <description>Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42.</description>
        <time_frame>Immediately after appointment (Same day as intervention delivery)</time_frame>
        <population>Only intervention participants saw the pamphlet and provided acceptability feedback</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Receive experiential pamphlet&#xD;
Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No materials, usual care</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Acceptability Questionnaire</title>
          <description>Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42.</description>
          <population>Only intervention participants saw the pamphlet and provided acceptability feedback</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="30"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery</title>
        <description>Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark &gt;70%), 2) percentage of eligible participants after screening (benchmark &gt;50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark &lt;20%), 4)percentage of participants who complete the experiential pamphlet (benchmark &gt;80%).</description>
        <time_frame>When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months</time_frame>
        <population>Tracked by participant flow, 295 participants invited to participate by research staff, eventually resulting 135 assessed for eligibility, and ultimately 62 randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Feasibility, Tracked by Participant Flow</title>
            <description>Feasibility was measured by tracking flow and calculating: 1) Percentage of patients who indicate verbal consent for screening, 2) percentage of eligible participants after screening, 2) percentage of participants who refuse to participate because of focus on weight, 3)percentage of participants who complete the experiential pamphlet. Study flow will be tracked by study staff and compared to pre-determined benchmarks</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery</title>
          <description>Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark &gt;70%), 2) percentage of eligible participants after screening (benchmark &gt;50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark &lt;20%), 4)percentage of participants who complete the experiential pamphlet (benchmark &gt;80%).</description>
          <population>Tracked by participant flow, 295 participants invited to participate by research staff, eventually resulting 135 assessed for eligibility, and ultimately 62 randomized</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of participants indicated verbal consent for screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of eligible participants after screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of screened participants who refuse to participate because of focus on weight</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants who complete the experiential pamphlet</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>If Weight Was Spoken About in the Appointment</title>
        <description>Participants respond to Yes/No questions about content of their appointment</description>
        <time_frame>Immediately after appointment (Same day as intervention delivery)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Receive experiential pamphlet&#xD;
Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No materials, usual care</description>
          </group>
        </group_list>
        <measure>
          <title>If Weight Was Spoken About in the Appointment</title>
          <description>Participants respond to Yes/No questions about content of their appointment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patient-initiated weight discussion occured</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient- or physician-initiated weight discussion occurred</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Collected data from participants during primary care appointment (approx. 15-90 min), data collection occurred over a period of 6 months</time_frame>
      <desc>This was a brief, low risk study of providing a pamphlet about health and weight to patients in the waiting room before a primary care appointment</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Receive experiential pamphlet&#xD;
Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>No materials, usual care</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>
    <limitations_and_caveats>Small sample size, location for study was primarily staffed by Family Medicine residents which may limit generalizability</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jocelyn Remmert, PhD</name_or_title>
      <organization>Corporal Michael J. Crescenz VA Medical Center</organization>
      <phone>215-823-5800</phone>
      <email>jocelyn.remmert@va.gov</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/NCT04486235
org study id: 1812006829
nct id: NCT04486235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study tests the feasibility, acceptability, and preliminary efficacy of using a brief
      pamphlet in the primary care waiting room focused on promoting patient-initiated
      weight-related discussions in primary care appointments.
Obesity is a chronic and complex disease that many national and professional organizations
      recommend be discussed frequently in primary care. However, rates of weight-related
      communication in primary care are suboptimal. When patients and physicians communicate about
      weight (defined as usage of any the 5As-ask, assess, advise, agree, and/or assist-in a
      weight-related conversation), patients are more likely to improve dietary habits, demonstrate
      more motivation for health behavior change, attempt weight loss treatment, and lose more
      weight as compared to patients who do not engage in weight-related communication with their
      physicians. Interventions have attempted to increase the rates of weight-related
      communication in primary care. However, they have focused solely on physicians and have only
      yielded modest efficacy. Intervention with patients on proposed patient-related barriers may
      be key to improving the rate of weight-related communication in primary care. The waiting
      room prior to appointments is an underutilized intervention setting. Prior waiting room
      interventions have shown promising results for increasing health communication between
      patients and physicians. However, no prior study has focused on weight-related communication.
      Thus, this study aims to test the feasibility, acceptability, and preliminary efficacy of an
      experiential pamphlet delivered in the waiting room targeting patient-related barriers to
      weight communication.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization is stratified. On the screening form, participants indicate whether or not they plan to speak with their physician about their weight in their appointment. Randomization is stratified by if if the participant indicates that they plan to speak about weight or not.
primary purpose: Other
masking: None (Open Label)
masking description: The condition of the participant is revealed after the participant completes the consent form and screening questionnaire and is deemed eligible.
measure: Treatment Acceptability Questionnaire
time frame: Immediately after appointment (Same day as intervention delivery)
description: Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42.
measure: Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
time frame: When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months
description: Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark >70%), 2) percentage of eligible participants after screening (benchmark >50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark <20%), 4)percentage of participants who complete the experiential pamphlet (benchmark >80%).
measure: If Weight Was Spoken About in the Appointment
time frame: Immediately after appointment (Same day as intervention delivery)
description: Participants respond to Yes/No questions about content of their appointment
arm group label: Intervention
arm group type: Experimental
description: Receive experiential pamphlet
arm group label: Control
arm group type: No Intervention
description: No materials, usual care
intervention type: Behavioral
intervention name: Brief waiting room pamphlet
description: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jocelyn Remmert, MS
role: Principal Investigator
affiliation: Drexel University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Gain
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size, location for study was primarily staffed by Family Medicine residents which may limit generalizability
point of contact: 