<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/NCT04451499</url>
  </required_header>
  <id_info>
    <org_study_id>0018-20-ASMC</org_study_id>
    <nct_id>NCT04451499</nct_id>
  </id_info>
  <brief_title>The Effect of Adding Smartphone-based Platform to the Bariatric Surgery Preparation Process</brief_title>
  <official_title>The Effect of Adding Smartphone-based Platform to the Bariatric Surgery Preparation Process</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assuta Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ariel University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assuta Medical Center</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>
      A randomized controlled trial on 40 bariatric surgery candidates who will be randomized into&#xD;
      two arms (app vs. control). All the participants will receive the standard care of 3-6&#xD;
      preparation to bariatric surgery meetings with a dietitian, and only those participants who&#xD;
      will assigned to the experimental group will get access to our study's smartphone app site&#xD;
      during this period.&#xD;
&#xD;
      Evaluations will be performed at baseline, at the end of the intervention phase (after 3-6&#xD;
      meetings as needed) and at 1 and 2 years post-surgery (data will be collected at 1 and 2&#xD;
      years post-surgery by phone calls).&#xD;
&#xD;
      Data which will be collected for this study include:demographics and medical data,&#xD;
      anthropometrics including body composition analysis, handgrip Strength, physical activity,&#xD;
      hydration state, bariatric surgery knowledge questionnaire, quality of life by visual&#xD;
      analogue scale, compliance to dietary and lifestyle BS recommendations, readiness for&#xD;
      surgery, the subject's experience regarding the smartphone app, surgical data and adherence&#xD;
      to post-surgical follow-up by the bariatric team.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial on 40 bariatric surgery candidates who will be recruited while&#xD;
      attending to the bariatric clinics and by advertisement about the study. Patients will be&#xD;
      randomized into two arms (app vs. control) using an online software. All the participants&#xD;
      will receive the standard care of 3-6 preparation to bariatric surgery meetings with a&#xD;
      dietitian, and only those participants who will be assigned to the experimental group will&#xD;
      get access to our study's smartphone app site during this period. The study specific&#xD;
      smartphone app site will be based on current literature plus investigators experience and&#xD;
      will include a wide knowledge on types of surgeries, dietary guidelines pre- and&#xD;
      post-surgery, fluids type and amount, knowledge on supplementation use pre and post-surgery,&#xD;
      general dietary knowledge, psychological information, physical activity, recommendation and&#xD;
      tips for long-term surgery success, emphasis will be made on long-term follow-up meetings&#xD;
      with the bariatric team and practical information on the preparation to the hospitalization&#xD;
      process. The smartphone app site will contain video-based modules and encouraging messages.&#xD;
      In addition, patients will be encouraged to use the platform to ask questions and receive&#xD;
      answers regarding any aspect of the surgery.&#xD;
&#xD;
      Evaluations will be performed at baseline, at the end of the intervention phase (after 3-6&#xD;
      meetings as needed) and at 1 and 2 years post-surgery (data will be collected at 1 and 2&#xD;
      years post-surgery by phone calls).&#xD;
&#xD;
      Data which will be collected for this study include:demographics and medical data,&#xD;
      anthropometrics including body composition analysis, handgrip Strength, physical activity,&#xD;
      hydration state, bariatric surgery knowledge questionnaire, quality of life by visual&#xD;
      analogue scale, compliance to dietary and lifestyle BS recommendations, readiness for&#xD;
      surgery, the subject's experience regarding the smartphone app, surgical data and adherence&#xD;
      to post-surgical follow-up by the bariatric team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in bariatric surgery nutrition-knowledge score</measure>
    <time_frame>Baseline and up to 3 months (end of the intervention phase)</time_frame>
    <description>Bariatric surgery nutrition-knowledge score will be measured by a validated questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in weight</measure>
    <time_frame>Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery</time_frame>
    <description>Weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>Baseline and up to 3 months (end of the intervention phase)</time_frame>
    <description>Body composition will be measured using multi-frequency bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functionality</measure>
    <time_frame>Baseline and up to 3 months (end of the intervention phase)</time_frame>
    <description>Handgrip muscle strength-test will be measured by a digital hand dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hydration state</measure>
    <time_frame>Baseline and up to 3 months (end of the intervention phase)</time_frame>
    <description>Patients will be asked to match the color that best describes their urine color according to a standardized urine color scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in step count</measure>
    <time_frame>Baseline and up to 3 months (end of the intervention phase)</time_frame>
    <description>Physical activity will be measured by pedometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in compliance to dietary and lifestyle bariatric surgery recommendations</measure>
    <time_frame>Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery</time_frame>
    <description>Patients will be asked if they kept the recommended behaviors by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life: VAS scale</measure>
    <time_frame>Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery</time_frame>
    <description>Patients will be asked to rate their overall state of health from 0-100 using a VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readiness for surgery</measure>
    <time_frame>Up to 3 months (end of the intervention phase)</time_frame>
    <description>Patients will be asked to rate their subjectively overall readiness to the surgery from 0-100 using a VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The subject's experience regarding the smartphone app</measure>
    <time_frame>Up to 3 months (end of the intervention phase)</time_frame>
    <description>Patients in the intervention arm will be ask about the ease of use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical time</measure>
    <time_frame>During surgery</time_frame>
    <description>Surgery time in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to post-surgical follow-up by the bariatric team</measure>
    <time_frame>1 and 2 years post-surgery</time_frame>
    <description>Patients will be ask how many meetings they had with the bariatric team since the surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Nutritional and Metabolic Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention group -smartphone app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.&#xD;
All the participants will get access to our study's smartphone app site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Smartphone app</intervention_name>
    <description>The study specific smartphone app site will be based on current literature plus investigators experience and will include a wide knowledge on types of surgeries, dietary guidelines pre- and post-surgery, fluids type and amount, knowledge on supplementation use pre and post-surgery, general dietary knowledge, psychological information, physical activity, recommendation and tips for long-term surgery success, emphasis will be made on long-term follow-up meetings with the bariatric team and practical information on the preparation to the hospitalization process. The smartphone app site will contain video-based modules and encouraging messages. Patients will be encouraged to use the platform to ask questions and receive answers regarding any aspect of the surgery.</description>
    <arm_group_label>Intervention group -smartphone app</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-surgery: 18 years old or older, BMI ≥ 40 kg/m² or BMI≥35 kg/m² with comorbidities.&#xD;
&#xD;
          -  Planned surgery types: LSG, RYGB and OAGB&#xD;
&#xD;
          -  Reading and speaking Hebrew.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous bariatric surgery.&#xD;
&#xD;
          -  Planned surgery types: LAGB or BPD-DS.&#xD;
&#xD;
          -  Patients who underwent more than 1 preparation to bariatric surgery meeting with a&#xD;
             dietitian.&#xD;
&#xD;
          -  Patients with an active psychiatric disorder (uncontrolled) or have other&#xD;
             contraindications to bariatric surgery such as addiction to alcohol or drugs.&#xD;
&#xD;
          -  Diabetic patients taking Insulin.&#xD;
&#xD;
          -  Patients who do not own a smartphone.&#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>Yafit Kessler, MSc</last_name>
    <phone>0097250691645</phone>
    <email>yafitke@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assuta Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiri Sherf-Dagan, PhD</last_name>
      <phone>+972-525122203</phone>
      <email>shirishe@assuta.co.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assuta Medical Center</investigator_affiliation>
    <investigator_full_name>Shiri Sherf Dagan</investigator_full_name>
    <investigator_title>Dietitian and Epidemiologist</investigator_title>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Smartphone-based education platform</keyword>
  <keyword>Pre-surgery preparation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04451499
org study id: 0018-20-ASMC
nct id: NCT04451499
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled trial on 40 bariatric surgery candidates who will be randomized into
      two arms (app vs. control). All the participants will receive the standard care of 3-6
      preparation to bariatric surgery meetings with a dietitian, and only those participants who
      will assigned to the experimental group will get access to our study's smartphone app site
      during this period.

      Evaluations will be performed at baseline, at the end of the intervention phase (after 3-6
      meetings as needed) and at 1 and 2 years post-surgery (data will be collected at 1 and 2
      years post-surgery by phone calls).

      Data which will be collected for this study include:demographics and medical data,
      anthropometrics including body composition analysis, handgrip Strength, physical activity,
      hydration state, bariatric surgery knowledge questionnaire, quality of life by visual
      analogue scale, compliance to dietary and lifestyle BS recommendations, readiness for
      surgery, the subject's experience regarding the smartphone app, surgical data and adherence
      to post-surgical follow-up by the bariatric team.
A randomized controlled trial on 40 bariatric surgery candidates who will be recruited while
      attending to the bariatric clinics and by advertisement about the study. Patients will be
      randomized into two arms (app vs. control) using an online software. All the participants
      will receive the standard care of 3-6 preparation to bariatric surgery meetings with a
      dietitian, and only those participants who will be assigned to the experimental group will
      get access to our study's smartphone app site during this period. The study specific
      smartphone app site will be based on current literature plus investigators experience and
      will include a wide knowledge on types of surgeries, dietary guidelines pre- and
      post-surgery, fluids type and amount, knowledge on supplementation use pre and post-surgery,
      general dietary knowledge, psychological information, physical activity, recommendation and
      tips for long-term surgery success, emphasis will be made on long-term follow-up meetings
      with the bariatric team and practical information on the preparation to the hospitalization
      process. The smartphone app site will contain video-based modules and encouraging messages.
      In addition, patients will be encouraged to use the platform to ask questions and receive
      answers regarding any aspect of the surgery.

      Evaluations will be performed at baseline, at the end of the intervention phase (after 3-6
      meetings as needed) and at 1 and 2 years post-surgery (data will be collected at 1 and 2
      years post-surgery by phone calls).

      Data which will be collected for this study include:demographics and medical data,
      anthropometrics including body composition analysis, handgrip Strength, physical activity,
      hydration state, bariatric surgery knowledge questionnaire, quality of life by visual
      analogue scale, compliance to dietary and lifestyle BS recommendations, readiness for
      surgery, the subject's experience regarding the smartphone app, surgical data and adherence
      to post-surgical follow-up by the bariatric team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in bariatric surgery nutrition-knowledge score
time frame: Baseline and up to 3 months (end of the intervention phase)
description: Bariatric surgery nutrition-knowledge score will be measured by a validated questionnaire
measure: Changes in weight
time frame: Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
description: Weight loss
measure: Changes in body composition
time frame: Baseline and up to 3 months (end of the intervention phase)
description: Body composition will be measured using multi-frequency bioelectrical impedance analysis
measure: Changes in functionality
time frame: Baseline and up to 3 months (end of the intervention phase)
description: Handgrip muscle strength-test will be measured by a digital hand dynamometer
measure: Changes in hydration state
time frame: Baseline and up to 3 months (end of the intervention phase)
description: Patients will be asked to match the color that best describes their urine color according to a standardized urine color scale
measure: Changes in step count
time frame: Baseline and up to 3 months (end of the intervention phase)
description: Physical activity will be measured by pedometers
measure: Changes in compliance to dietary and lifestyle bariatric surgery recommendations
time frame: Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
description: Patients will be asked if they kept the recommended behaviors by a questionnaire
measure: Changes in quality of life: VAS scale
time frame: Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
description: Patients will be asked to rate their overall state of health from 0-100 using a VAS scale
measure: Readiness for surgery
time frame: Up to 3 months (end of the intervention phase)
description: Patients will be asked to rate their subjectively overall readiness to the surgery from 0-100 using a VAS scale
measure: The subject's experience regarding the smartphone app
time frame: Up to 3 months (end of the intervention phase)
description: Patients in the intervention arm will be ask about the ease of use
measure: Surgical time
time frame: During surgery
description: Surgery time in minutes
measure: Adherence to post-surgical follow-up by the bariatric team
time frame: 1 and 2 years post-surgery
description: Patients will be ask how many meetings they had with the bariatric team since the surgery
arm group label: Intervention group -smartphone app
arm group type: Experimental
description: All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.
All the participants will get access to our study's smartphone app site.
arm group label: Control group
arm group type: No Intervention
description: All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.
intervention type: Other
intervention name: Smartphone app
description: The study specific smartphone app site will be based on current literature plus investigators experience and will include a wide knowledge on types of surgeries, dietary guidelines pre- and post-surgery, fluids type and amount, knowledge on supplementation use pre and post-surgery, general dietary knowledge, psychological information, physical activity, recommendation and tips for long-term surgery success, emphasis will be made on long-term follow-up meetings with the bariatric team and practical information on the preparation to the hospitalization process. The smartphone app site will contain video-based modules and encouraging messages. Patients will be encouraged to use the platform to ask questions and receive answers regarding any aspect of the surgery.
arm group label: Intervention group -smartphone app
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yafit Kessler, MSc
phone: 0097250691645
email: yafitke@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Assuta Medical Center
investigator full name: Shiri Sherf Dagan
investigator title: Dietitian and Epidemiologist
mesh term: Metabolic Diseases
sharing ipd: No