<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/NCT03006328</url>
  </required_header>
  <id_info>
    <org_study_id>16-01445</org_study_id>
    <nct_id>NCT03006328</nct_id>
  </id_info>
  <brief_title>The GEM (Goals for Eating and Moving) Study</brief_title>
  <acronym>GEM</acronym>
  <official_title>Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
      The GEM intervention leverages the patient-centered medical home model by using the GEM tool&#xD;
      to provide individually tailored, patient-centered care, promote standardized weight&#xD;
      management counseling by health coaches and primary team members, coordinate care between&#xD;
      teams and other weight management service providers/programs (e.g., dietitians, health&#xD;
      educators, DPP), and provide feedback to the provider and primary care team about patients'&#xD;
      weight management-related goals, progress, and care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To establish the efficacy of the GEM intervention, investigators will conduct a cluster&#xD;
      randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare&#xD;
      systems with Medical Home models of care to compare the GEM intervention (intervention arm)&#xD;
      with Enhanced Usual Care (educational materials; control arm).&#xD;
&#xD;
      The specific aims of this study are:&#xD;
&#xD;
        -  Test the impact of the GEM intervention on weight change, and clinical and behavioral&#xD;
           outcomes.&#xD;
&#xD;
        -  Identify predictors of weight loss in the GEM intervention arm related to: a)&#xD;
           goal-setting processes and b) intervention components&#xD;
&#xD;
        -  Determine the impact of the GEM intervention on obesity-related counseling practices and&#xD;
           attitudes in primary care providers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Actual">February 22, 2022</completion_date>
  <primary_completion_date type="Actual">May 20, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Weight From Baseline</measure>
    <time_frame>Baseline, Month 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Waist Circumference From Baseline</measure>
    <time_frame>Baseline, Month 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Systolic Blood Pressure (SBP) From Baseline</measure>
    <time_frame>Baseline, Month 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Diastolic Blood Pressure (DBP) From Baseline</measure>
    <time_frame>Baseline, Month 12</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">489</enrollment>
  <condition>Weight Gain</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Participants with Obesity + GEM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants with Obesity + Enhanced Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>GEM</intervention_name>
    <description>Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
    <arm_group_label>Participants with Obesity + GEM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Usual Care</intervention_name>
    <description>Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
    <arm_group_label>Participants with Obesity + Enhanced Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18-69 years of age,&#xD;
&#xD;
          -  Body mass index of ≥30kg/m2 OR&#xD;
&#xD;
          -  Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  High Cholesterol&#xD;
&#xD;
          -  Sleep Apnea&#xD;
&#xD;
          -  Osteoarthritis&#xD;
&#xD;
          -  Metabolic Syndrome&#xD;
&#xD;
          -  Prediabetes&#xD;
&#xD;
          -  Under primary care team care with at least one prior visit with their provider in the&#xD;
             past 24 months&#xD;
&#xD;
          -  Access to a telephone, and ability to travel for in-person evaluations at baseline, 6,&#xD;
             12, and 24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not speak English or Spanish,&#xD;
&#xD;
          -  Have active psychosis or other cognitive issues,&#xD;
&#xD;
          -  Psychoactive substance use&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Taking prescription weight-loss medication&#xD;
&#xD;
          -  Health condition that may prohibit the patient from walking or physical activity such&#xD;
             as chest tightness, a heart condition, or severe arthritis&#xD;
&#xD;
          -  Participated in MOVE!, DPP, or another intensive weight management program (&gt;3&#xD;
             sessions) in the past year,&#xD;
&#xD;
          -  Have a history of bariatric surgery,&#xD;
&#xD;
          -  Are pregnant, or become pregnant during the intervention period,&#xD;
&#xD;
          -  Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment,&#xD;
&#xD;
          -  Have a provider who states they should not participate,&#xD;
&#xD;
          -  Patients who do not want to lose weight&#xD;
&#xD;
          -  Have self-reported inability to read at 5th grade level.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melanie Jay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University Medical Center Institutional Review Boards</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <results_first_submitted>February 24, 2023</results_first_submitted>
  <results_first_submitted_qc>April 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2023</results_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>weight gain</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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>December 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03006328/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Participants With Obesity + GEM</title>
          <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Participants With Obesity + Enhanced Usual Care</title>
          <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="220"/>
                <participants group_id="P2" count="269"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="220"/>
                <participants group_id="P2" count="269"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Participants With Obesity + GEM</title>
          <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
        </group>
        <group group_id="B2">
          <title>Participants With Obesity + Enhanced Usual Care</title>
          <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</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="220"/>
            <count group_id="B2" value="269"/>
            <count group_id="B3" value="489"/>
          </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="49.2" spread="12.1"/>
                    <measurement group_id="B2" value="50.2" spread="11.6"/>
                    <measurement group_id="B3" value="49.8" spread="12.1"/>
                  </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="116"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="273"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="216"/>
                  </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="99"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="282"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="238"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="152"/>
                  </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="220"/>
                    <measurement group_id="B2" value="269"/>
                    <measurement group_id="B3" value="489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Weight From Baseline</title>
        <time_frame>Baseline, Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants With Obesity + GEM</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Participants With Obesity + Enhanced Usual Care</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Weight From Baseline</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
                <count group_id="O2" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="0.8"/>
                    <measurement group_id="O2" value="-0.8" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Waist Circumference From Baseline</title>
        <time_frame>Baseline, Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants With Obesity + GEM</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Participants With Obesity + Enhanced Usual Care</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Waist Circumference From Baseline</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
                <count group_id="O2" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="0.5"/>
                    <measurement group_id="O2" value="-0.6" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Systolic Blood Pressure (SBP) From Baseline</title>
        <time_frame>Baseline, Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants With Obesity + GEM</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Participants With Obesity + Enhanced Usual Care</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure (SBP) From Baseline</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
                <count group_id="O2" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.7"/>
                    <measurement group_id="O2" value="3.2" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Diastolic Blood Pressure (DBP) From Baseline</title>
        <time_frame>Baseline, Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants With Obesity + GEM</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Participants With Obesity + Enhanced Usual Care</title>
            <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diastolic Blood Pressure (DBP) From Baseline</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
                <count group_id="O2" value="269"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.4"/>
                    <measurement group_id="O2" value="3.2" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Participants With Obesity + GEM</title>
          <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.&#xD;
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.</description>
        </group>
        <group group_id="E2">
          <title>Participants With Obesity + Enhanced Usual Care</title>
          <description>Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.&#xD;
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="81" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood Transfusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac heart catheterization</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Heart and blood vessel issues</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Heart Attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Cardiac Arrythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retina Surgery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Gallbladder Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Autoimmune Disorder on Eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>COVID-19 infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Leg fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Motor vehicle accident</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Wound requiring stitches</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Severe muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Arm paralysis secondary to botox injection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Metal in eye, work injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Wrist/hand injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Broken ribs</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Work accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Severe pain in feet</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Joint pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Knee pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Lumbar scoliosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Biopsy resulted in needing catheterization</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Breast Cancer Surgery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Complications after biopsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Prostate Cancer Operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Skin cancer removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Small tumor found on kidney</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraines</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Loss of consciousness/fainting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Scrotal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Possible Panic Attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney pain/stones</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Contact Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abdominal Surgery</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Appendix Removed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Knee surgery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Spinal operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Surgery for parathyroid removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Urology surgery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pains</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headaches from sinus issues</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Sinus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Staphylococcus aureus infection in leg</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Motor vehicle accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Victim of assault</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Wrist/hand injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Ankle pain due to injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Injury requiring physical therapy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Foot sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute muscle spasm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Plantar faciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Knee Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Diffuse muscle pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Shoulder pain/injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cyst in arm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Endoscopy and colonoscopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Lipoma in left abdomen</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Lightheaded, dizzy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Migraines</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney pain/stones</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Enlarged Prostate</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Abcess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Contact Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Catheter Adjusted Due to Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Catheter Removed</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Tonsil Removal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="269"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="269"/>
              </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 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>Sandra Wittleder, PhD</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>212-263-4149</phone>
      <email>sandra.wittleder@nyulangone.org</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/NCT03006328
org study id: 16-01445
nct id: NCT03006328
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The GEM intervention leverages the patient-centered medical home model by using the GEM tool
      to provide individually tailored, patient-centered care, promote standardized weight
      management counseling by health coaches and primary team members, coordinate care between
      teams and other weight management service providers/programs (e.g., dietitians, health
      educators, DPP), and provide feedback to the provider and primary care team about patients'
      weight management-related goals, progress, and care.
To establish the efficacy of the GEM intervention, investigators will conduct a cluster
      randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare
      systems with Medical Home models of care to compare the GEM intervention (intervention arm)
      with Enhanced Usual Care (educational materials; control arm).

      The specific aims of this study are:

        -  Test the impact of the GEM intervention on weight change, and clinical and behavioral
           outcomes.

        -  Identify predictors of weight loss in the GEM intervention arm related to: a)
           goal-setting processes and b) intervention components

        -  Determine the impact of the GEM intervention on obesity-related counseling practices and
           attitudes in primary care providers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Change in Weight From Baseline
time frame: Baseline, Month 12
measure: Change in Waist Circumference From Baseline
time frame: Baseline, Month 12
measure: Change in Systolic Blood Pressure (SBP) From Baseline
time frame: Baseline, Month 12
measure: Change in Diastolic Blood Pressure (DBP) From Baseline
time frame: Baseline, Month 12
arm group label: Participants with Obesity + GEM
arm group type: Experimental
description: Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
arm group label: Participants with Obesity + Enhanced Usual Care
arm group type: Active Comparator
description: Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
intervention type: Behavioral
intervention name: GEM
description: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
arm group label: Participants with Obesity + GEM
intervention type: Behavioral
intervention name: Enhanced Usual Care
description: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
arm group label: Participants with Obesity + Enhanced Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Melanie Jay, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Gain
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 