<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/NCT03792412</url>
  </required_header>
  <id_info>
    <org_study_id>2079/2017</org_study_id>
    <nct_id>NCT03792412</nct_id>
  </id_info>
  <brief_title>BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management</brief_title>
  <official_title>BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management Evaluation of a Post-operative Nutrition and Lifestyle Management for Lifelong Care of Post-bariatric Patients in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      There is a growing number of patients undergoing bariatric surgery requiring lifelong&#xD;
      follow-up. BagEL (Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle&#xD;
      Management) is a survey to evaluate a newly developed structured disease management program&#xD;
      including nutrition and lifestyle management in primary care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During last decades the prevalence of obesity is growing. Therefore, the number of bariatric&#xD;
      procedures are also increasing. Frequent complications after surgery are nutritional&#xD;
      deficiencies (e.g. vitamins, minerals, protein) which require mandatory long-term follow-up.&#xD;
      So far adequate follow-up programs are only provided in specialized bariatric centers like in&#xD;
      the outpatient clinic for obesity at the General Hospital of Vienna. These programs are&#xD;
      focusing on prevention and premature identification of deficiencies.&#xD;
&#xD;
      Rising numbers of bariatric-surgical procedures pose a challenge for bariatric centres&#xD;
      because of the accumulating numbers of bariatric patients requesting follow-up at least once&#xD;
      a year.&#xD;
&#xD;
      To provide full coverage an appropriate possibility would be to transfer follow up to&#xD;
      non-specialised facilities including general practitioners and family doctors using a so&#xD;
      called &quot;pass&quot; providing practical treatment recommendations (necessary follow-up&#xD;
      appointments, laboratory blood tests, questions regarding nutrition and lifestyle behavior).&#xD;
&#xD;
      To our best knowledge such a structured post-bariatric care management program in primary&#xD;
      care does not exist by now. The aim of this study is therefore the evaluation of such a pass.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 22, 2018</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomised cohort study with control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>pseudonymity</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Usability questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Usability of the follow-up passes (intervention and control) will be evaluated in primary care. In a pilot study the usability questionnaire was evaluated.&#xD;
The patient hands over the follow-up pass together with the questionnaire at each appointment (twice) at the family doctor. A stamped envelope to return the questionnaire is included. Family doctors will be asked to complete a series of actions regarding the content of the follow-up passes. Each action will be rated in a 5 point likert scale. An average score will be calculated for each question.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in fat free mass</measure>
    <time_frame>6 months</time_frame>
    <description>A Bioelectric impedance analysis will be used to calculate change in fat free mass. Measurements will be conducted by a device sending weak electric signals through the patients body. The method is non-invasive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in body weight</measure>
    <time_frame>6 months</time_frame>
    <description>Patients will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using a digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of adherence after 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients returning to the outpatient clinic after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcium Blood Value</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Calcium levels (mg/dL) after 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron Blood Value</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Ferritin levels (ng/mL) after 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin B12 Blood Value</measure>
    <time_frame>6 months</time_frame>
    <description>Change in B12 levels (pmol/L) after 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D Blood Value</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Folic Acid Blood Value</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Folic Acid levels (nmol/L) after 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c Blood Value</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Hemoglobin A1c (%) after 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Intervention: Usability Questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients hand over the usability questionnaire to evaluate the self developed structured follow-up program in form of a so-called pass to their family doctor twice in six months. Family doctors examine the postbariatric patient using the pass and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Usability Questionnaire</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients hand over the usability questionnaire to evaluate the state of the art guideline for postbariatric follow up appointments in form of a folder &quot;Metabolische Chirurgie und die perioperative Betreuung&quot; to their family doctor twice in six months. Family doctors examine the postbariatric patient using the guideline and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usability Questionnaire</intervention_name>
    <description>Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits. Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients. Family doctors fill out the questionnaire and returns it to the investigator.</description>
    <arm_group_label>Control: Usability Questionnaire</arm_group_label>
    <arm_group_label>Intervention: Usability Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  older than 18 years and each sex,&#xD;
&#xD;
          -  bariatric-surgical treatment - in particular omega loop gastric bypass,&#xD;
             Roux-en-Y-gastric bypass - and sleeve gastrectomy at the department of surgery General&#xD;
             Hospital Vienna,&#xD;
&#xD;
          -  Operation date maximum 21 months before study beginning,&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Pregnancy (a possible existing pregnancy is excluded by questioning)&#xD;
&#xD;
          -  Nursing mothers&#xD;
&#xD;
          -  Not German speaking patients&#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_contact>
    <last_name>Tamara Ranzenberger-Haider, MSc</last_name>
    <phone>00436765202648</phone>
    <email>tamara.ranzenberger-haider@muv.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Krebs, Prof.Dr.</last_name>
    <phone>+43 (0)1 40400-72570</phone>
    <email>michael.krebs@muv.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <state>Please Select</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tamara Ranzenberger-Haider, MSc</last_name>
      <phone>00436765202648</phone>
      <email>tamara.ranzenberger-haider@muv.ac.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Michael Krebs</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>bariatric surgery</keyword>
  <keyword>lifelong follow-up</keyword>
  <keyword>primary care</keyword>
  <keyword>obesity</keyword>
  <keyword>health care study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03792412
org study id: 2079/2017
nct id: NCT03792412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a growing number of patients undergoing bariatric surgery requiring lifelong
      follow-up. BagEL (Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle
      Management) is a survey to evaluate a newly developed structured disease management program
      including nutrition and lifestyle management in primary care.
During last decades the prevalence of obesity is growing. Therefore, the number of bariatric
      procedures are also increasing. Frequent complications after surgery are nutritional
      deficiencies (e.g. vitamins, minerals, protein) which require mandatory long-term follow-up.
      So far adequate follow-up programs are only provided in specialized bariatric centers like in
      the outpatient clinic for obesity at the General Hospital of Vienna. These programs are
      focusing on prevention and premature identification of deficiencies.

      Rising numbers of bariatric-surgical procedures pose a challenge for bariatric centres
      because of the accumulating numbers of bariatric patients requesting follow-up at least once
      a year.

      To provide full coverage an appropriate possibility would be to transfer follow up to
      non-specialised facilities including general practitioners and family doctors using a so
      called "pass" providing practical treatment recommendations (necessary follow-up
      appointments, laboratory blood tests, questions regarding nutrition and lifestyle behavior).

      To our best knowledge such a structured post-bariatric care management program in primary
      care does not exist by now. The aim of this study is therefore the evaluation of such a pass.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomised cohort study with control group
primary purpose: Treatment
masking: Single (Participant)
masking description: pseudonymity
measure: Usability questionnaire
time frame: 6 months
description: Usability of the follow-up passes (intervention and control) will be evaluated in primary care. In a pilot study the usability questionnaire was evaluated.
The patient hands over the follow-up pass together with the questionnaire at each appointment (twice) at the family doctor. A stamped envelope to return the questionnaire is included. Family doctors will be asked to complete a series of actions regarding the content of the follow-up passes. Each action will be rated in a 5 point likert scale. An average score will be calculated for each question.
measure: change in fat free mass
time frame: 6 months
description: A Bioelectric impedance analysis will be used to calculate change in fat free mass. Measurements will be conducted by a device sending weak electric signals through the patients body. The method is non-invasive.
measure: change in body weight
time frame: 6 months
description: Patients will be asked to remove shoes, socks, heavy clothing and jewelry for measurement of body weight to the nearest 100 g using a digital scale.
measure: Measures of adherence after 6 months
time frame: 6 months
description: Number of patients returning to the outpatient clinic after the intervention.
measure: Calcium Blood Value
time frame: 6 months
description: Change in Calcium levels (mg/dL) after 6 months
measure: Iron Blood Value
time frame: 6 months
description: Change in Ferritin levels (ng/mL) after 6 months
measure: Vitamin B12 Blood Value
time frame: 6 months
description: Change in B12 levels (pmol/L) after 6 months
measure: Vitamin D Blood Value
time frame: 6 months
description: Change in Vitamin D, 25-Hydroxy levels (nmol/L) after 6 months
measure: Folic Acid Blood Value
time frame: 6 months
description: Change in Folic Acid levels (nmol/L) after 6 months
measure: HbA1c Blood Value
time frame: 6 months
description: Change in Hemoglobin A1c (%) after 6 months
arm group label: Intervention: Usability Questionnaire
arm group type: Experimental
description: Patients hand over the usability questionnaire to evaluate the self developed structured follow-up program in form of a so-called pass to their family doctor twice in six months. Family doctors examine the postbariatric patient using the pass and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.
arm group label: Control: Usability Questionnaire
arm group type: Other
description: Patients hand over the usability questionnaire to evaluate the state of the art guideline for postbariatric follow up appointments in form of a folder "Metabolische Chirurgie und die perioperative Betreuung" to their family doctor twice in six months. Family doctors examine the postbariatric patient using the guideline and evaluate the usability by filling out the questionnaire and return the usability questionnaire to the investigator.
intervention type: Other
intervention name: Usability Questionnaire
description: Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits. Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients. Family doctors fill out the questionnaire and returns it to the investigator.
arm group label: Control: Usability Questionnaire
arm group label: Intervention: Usability Questionnaire
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tamara Ranzenberger-Haider, MSc
phone: 00436765202648
email: tamara.ranzenberger-haider@muv.ac.at
last name: Michael Krebs, Prof.Dr.
phone: +43 (0)1 40400-72570
email: michael.krebs@muv.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Prof. Dr. Michael Krebs
investigator title: Clinical Professor
mesh term: Malnutrition