xml: <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/NCT06033690</url>
    </required_header>
    <id_info>
      <org_study_id>UP5815/20</org_study_id>
      <nct_id>NCT06033690</nct_id>
    </id_info>
    <brief_title>Intervention in the Surgical Treatment of Obesity</brief_title>
    <official_title>Intervention Beyond Multidisciplinarity in the Surgical Treatment of Obesity Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto de Cardiologia do Rio Grande do Sul</source>
    <oversight_info>
      <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>
        The worldwide prevalence of obesity reaching epidemic levels, and directly associated with&#xD;
        several non-communicable chronic diseases, being considered the sixth leading cause of death&#xD;
        in the world. In Brazil, estimated that one third of the population is overweight. Currently,&#xD;
        bariatric surgery the fastest and most effective method to control the disease. However, most&#xD;
        patients do not follow the postoperative follow-up protocol, causing weight regain.&#xD;
        Intervention in the literature that goes beyond multidisciplinary and can prevent weight&#xD;
        relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the&#xD;
        Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight&#xD;
        relapse patients and bariatric surgery&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this randomized clinical study is to compare the eating behavior of obese&#xD;
        participants who underwent the dietary guide after bariatric surgery treatment. The main&#xD;
        questions are:&#xD;
  &#xD;
          -  Can an interdisciplinary intervention through a dietary guide promote a change in eating&#xD;
             behavior in participants undergoing surgical treatment for obesity?&#xD;
  &#xD;
          -  Participants will participate in consultations and receive a food guidance guide and&#xD;
             lectures with guidance.&#xD;
  &#xD;
          -  Researchers will compare intervention and control groups to see if there will be changes&#xD;
             in eating behavior&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 8, 2021</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">December 12, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>the two groups were randomized by online program, into intervention group and control group</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>behavior</measure>
      <time_frame>40 minutes</time_frame>
      <description>participants' scores in a pre- and post-intervention food assessment questionnaire</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">18</enrollment>
    <condition>Obesity, Morbid</condition>
    <arm_group>
      <arm_group_label>multidisciplinary guide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Consultation and multidisciplinary guide with guidance on physical activity and healthy eating.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Consultations with a multidisciplinary team</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>multidisciplinary guide</intervention_name>
      <description>use of the food guide for education, clarification of doubts</description>
      <arm_group_label>multidisciplinary guide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
          Referred for bariatric surgery Having or not comorbidity associated with obesity.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          not signing the informed consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Izabele Vian</last_name>
      <role>Study Director</role>
      <affiliation>Cardiology Institute</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Izabele Vian</name>
        <address>
          <city>Porto Alegre</city>
          <state>Rio Grande Do Sul</state>
          <zip>91000000</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>obesity</keyword>
    <keyword>bariatric surgery</keyword>
    <keyword>food guide</keyword>
    <keyword>interdisciplinarity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Obesity, Morbid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033690
  org study id: UP5815/20
  nct id: NCT06033690
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The worldwide prevalence of obesity reaching epidemic levels, and directly associated with
        several non-communicable chronic diseases, being considered the sixth leading cause of death
        in the world. In Brazil, estimated that one third of the population is overweight. Currently,
        bariatric surgery the fastest and most effective method to control the disease. However, most
        patients do not follow the postoperative follow-up protocol, causing weight regain.
        Intervention in the literature that goes beyond multidisciplinary and can prevent weight
        relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the
        Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight
        relapse patients and bariatric surgery
  The objective of this randomized clinical study is to compare the eating behavior of obese
        participants who underwent the dietary guide after bariatric surgery treatment. The main
        questions are:
  
          -  Can an interdisciplinary intervention through a dietary guide promote a change in eating
             behavior in participants undergoing surgical treatment for obesity?
  
          -  Participants will participate in consultations and receive a food guidance guide and
             lectures with guidance.
  
          -  Researchers will compare intervention and control groups to see if there will be changes
             in eating behavior
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: the two groups were randomized by online program, into intervention group and control group
  measure: behavior
  time frame: 40 minutes
  description: participants' scores in a pre- and post-intervention food assessment questionnaire
  arm group label: multidisciplinary guide
  arm group type: Experimental
  description: Consultation and multidisciplinary guide with guidance on physical activity and healthy eating.
  arm group label: Control
  arm group type: No Intervention
  description: Consultations with a multidisciplinary team
  intervention type: Behavioral
  intervention name: multidisciplinary guide
  description: use of the food guide for education, clarification of doubts
  arm group label: multidisciplinary guide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Izabele Vian
  role: Study Director
  affiliation: Cardiology Institute
  facility: 
  country: Brazil
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Obesity, Morbid
  sharing ipd: No