<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/NCT03246672</url>
  </required_header>
  <id_info>
    <org_study_id>PPO 16-331</org_study_id>
    <nct_id>NCT03246672</nct_id>
  </id_info>
  <brief_title>Development of a Weight Maintenance Intervention for Bariatric Surgery Patients</brief_title>
  <acronym>MAINTAIN-B</acronym>
  <official_title>Development of a Weight Maintenance Intervention for Bariatric Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although bariatric surgery is highly effective for inducing significant weight loss and&#xD;
      resolution of comorbidities, weight regain following surgery is a common problem. This pilot&#xD;
      study will test the feasibility and acceptability of an intervention designed to help&#xD;
      bariatric surgery patients maintain weight loss. Findings from this pilot will provide the&#xD;
      foundation for a randomized controlled trial to evaluate the efficacy of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first intervention telephone call will occur one week following the baseline assessment.&#xD;
      Calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during&#xD;
      months 2-4 (weeks 6, 8, 10, 12, 14). The goal of this intervention is to increase adherence&#xD;
      to recommendations that patients are already receiving from their bariatric team as part of&#xD;
      standard of care. Thus, each call will address maintenance skill building and anticipatory&#xD;
      problem solving based on the processes outlined in the investigators' conceptual model and&#xD;
      operationalized in the investigators' previous weight loss maintenance protocol. Relapse&#xD;
      prevention planning will help patients identify situations in which overeating is common in&#xD;
      the bariatric population (e.g., loss of control eating related to emotions, disinhibition).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants receive the intervention</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment Rate</measure>
    <time_frame>week 0</time_frame>
    <description>Percentage of contacted patients who consent to be in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention Rate</measure>
    <time_frame>16-week outcome assessment</time_frame>
    <description>Percentage of patients with baseline data who complete 16-week outcome assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>16 weeks</time_frame>
    <description>Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>maintenance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>behavioral intervention to increase adherence to lifestyle recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>maintenance intervention</intervention_name>
    <description>Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</description>
    <arm_group_label>maintenance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bariatric surgery at a participating VA site&#xD;
&#xD;
          -  Laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic vertical sleeve&#xD;
             gastrectomy (SG) six to 18 months prior to the time of data pull&#xD;
&#xD;
          -  English as preferred language&#xD;
&#xD;
          -  Regular access to a telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of procedure to prevent gastric cancer&#xD;
&#xD;
          -  Revisional bariatric surgery&#xD;
&#xD;
          -  Hearing impairment&#xD;
&#xD;
          -  Cancer not in remission&#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>Corrine I. Voils, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William S. Middleton Memorial Veterans Hospital, Madison, WI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William S. Middleton Memorial Veterans Hospital, Madison, WI</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Adamek KE, Ramadurai D, Gunzburger E, Plomondon ME, Ho PM, Raghavan S. Association of Diabetes Mellitus Status and Glycemic Control With Secondary Prevention Medication Adherence After Acute Myocardial Infarction. J Am Heart Assoc. 2019 Feb 5;8(3):e011448. doi: 10.1161/JAHA.118.011448.</citation>
    <PMID>30712488</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <results_first_submitted>April 17, 2019</results_first_submitted>
  <results_first_submitted_qc>July 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 19, 2019</results_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity, morbid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03246672/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from January to March 2018. These participants were identified using electronic medical record data indicating that they had bariatric surgery for weight loss at one of four VA hospitals: West Roxbury, MA; Long Beach, CA; Palo Alto, CA; and Ann Arbor, MI.</recruitment_details>
      <pre_assignment_details>33 participants provided verbal consent. Of those, 3 were unable to be reached and 30 were reached by telephone to complete baseline measures and were scheduled for their first intervention phone call. Of those 30, 29 participants were reached for the first intervention phone call, and 1 participant unable to be reached for further participation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Maintenance</title>
          <description>behavioral intervention to increase adherence to lifestyle recommendations&#xD;
maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed First Phone Call</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>30 participants completed baseline measures.</population>
      <group_list>
        <group group_id="B1">
          <title>Maintenance</title>
          <description>behavioral intervention to increase adherence to lifestyle recommendations&#xD;
maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </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="56.9" spread="10.0"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recruitment Rate</title>
        <description>Percentage of contacted patients who consent to be in the study</description>
        <time_frame>week 0</time_frame>
        <population># of patients for whom phone screening was attempted</population>
        <group_list>
          <group group_id="O1">
            <title>Maintenance</title>
            <description>behavioral intervention to increase adherence to lifestyle recommendations&#xD;
maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</description>
          </group>
        </group_list>
        <measure>
          <title>Recruitment Rate</title>
          <description>Percentage of contacted patients who consent to be in the study</description>
          <population># of patients for whom phone screening was attempted</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Retention Rate</title>
        <description>Percentage of patients with baseline data who complete 16-week outcome assessments</description>
        <time_frame>16-week outcome assessment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Maintenance</title>
            <description>behavioral intervention to increase adherence to lifestyle recommendations&#xD;
maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention Rate</title>
          <description>Percentage of patients with baseline data who complete 16-week outcome assessments</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date</description>
        <time_frame>16 weeks</time_frame>
        <population>The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles</population>
        <group_list>
          <group group_id="O1">
            <title>Maintenance</title>
            <description>behavioral intervention to increase adherence to lifestyle recommendations&#xD;
maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date</description>
          <population>The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213.7" spread="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <desc>Adverse events were volunteered by participants during intervention or assessment phone calls; they were not systematically queried in this minimal-risk intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>Maintenance</title>
          <description>behavioral intervention to increase adherence to lifestyle recommendations&#xD;
maintenance intervention: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" 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="30"/>
              </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>Dr. Corrine Voils</name_or_title>
      <organization>William S Middleton Memorial Veterans Hospital</organization>
      <phone>608-262-9636</phone>
      <email>corrine.voils@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/NCT03246672
org study id: PPO 16-331
nct id: NCT03246672
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Although bariatric surgery is highly effective for inducing significant weight loss and
      resolution of comorbidities, weight regain following surgery is a common problem. This pilot
      study will test the feasibility and acceptability of an intervention designed to help
      bariatric surgery patients maintain weight loss. Findings from this pilot will provide the
      foundation for a randomized controlled trial to evaluate the efficacy of the intervention.
The first intervention telephone call will occur one week following the baseline assessment.
      Calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during
      months 2-4 (weeks 6, 8, 10, 12, 14). The goal of this intervention is to increase adherence
      to recommendations that patients are already receiving from their bariatric team as part of
      standard of care. Thus, each call will address maintenance skill building and anticipatory
      problem solving based on the processes outlined in the investigators' conceptual model and
      operationalized in the investigators' previous weight loss maintenance protocol. Relapse
      prevention planning will help patients identify situations in which overeating is common in
      the bariatric population (e.g., loss of control eating related to emotions, disinhibition).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants receive the intervention
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment Rate
time frame: week 0
description: Percentage of contacted patients who consent to be in the study
measure: Retention Rate
time frame: 16-week outcome assessment
description: Percentage of patients with baseline data who complete 16-week outcome assessments
measure: Weight
time frame: 16 weeks
description: Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date
arm group label: maintenance
arm group type: Experimental
description: behavioral intervention to increase adherence to lifestyle recommendations
intervention type: Behavioral
intervention name: maintenance intervention
description: Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.
arm group label: maintenance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Corrine I. Voils, PhD
role: Principal Investigator
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
facility: 
country: United States
citation: Adamek KE, Ramadurai D, Gunzburger E, Plomondon ME, Ho PM, Raghavan S. Association of Diabetes Mellitus Status and Glycemic Control With Secondary Prevention Medication Adherence After Acute Myocardial Infarction. J Am Heart Assoc. 2019 Feb 5;8(3):e011448. doi: 10.1161/JAHA.118.011448.
PMID: 30712488
responsible party type: Sponsor
mesh term: Obesity, Morbid
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 