<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/NCT01708135</url>
  </required_header>
  <id_info>
    <org_study_id>12-005535</org_study_id>
    <nct_id>NCT01708135</nct_id>
  </id_info>
  <brief_title>Feasibility of Use of BariCare App in Pre-bariatric Surgery.</brief_title>
  <official_title>Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This current study aims to evaluate the efficacy of engagement modules in preparing patients&#xD;
      for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app&#xD;
      (Android and Apple compatible) has been created that will assist in both educating and&#xD;
      engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to&#xD;
      create a cost-effective, smartphone-based platform that serves to not only efficiently&#xD;
      educate but to also verify competence and keep our patients engaged during the lengthy&#xD;
      pre-bariatric surgery process.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smart phone app feasibility</measure>
    <time_frame>3 months</time_frame>
    <description>All subjects will complete a Bariatric Surgery Questionnaire consisting of 30 questions that assess their knowldege in areas of nutrition, physical activity, and bariatric surgery. They will also be given a questionnaire on physical activity (International physical activity questionnaire or IPAQ). The primary objective is to assess improvement on both of these questionnaires with use of app.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of use of app</measure>
    <time_frame>3 months</time_frame>
    <description>Through a questionnaire provided at the end of study, we will be gathering input from participants regarding ease of use of app, things they would like added or removed, as well as if they found modules helpful.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Smartphone Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in preparing for bariatric surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of smartphone app</intervention_name>
    <arm_group_label>Smartphone Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients, who upon completion of an evaluation by Endocrinology, are considered&#xD;
             appropriate to pursue a primary, laparoscopic bariatric surgery.&#xD;
&#xD;
          2. Patients who are 18 years of age or greater.&#xD;
&#xD;
          3. Patients who own a smartphone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of a prior bariatric surgery.&#xD;
&#xD;
          2. Patients with active psychiatric disorder(s).&#xD;
&#xD;
          3. Patients with active tobacco use.&#xD;
&#xD;
          4. Patients with active substance use (alcohol, illicit drugs, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manpreet Mundi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Manpreet S. Mundi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01708135
org study id: 12-005535
nct id: NCT01708135
lead sponsor: 
has dmc: No
This current study aims to evaluate the efficacy of engagement modules in preparing patients
      for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app
      (Android and Apple compatible) has been created that will assist in both educating and
      engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to
      create a cost-effective, smartphone-based platform that serves to not only efficiently
      educate but to also verify competence and keep our patients engaged during the lengthy
      pre-bariatric surgery process.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Smart phone app feasibility
time frame: 3 months
description: All subjects will complete a Bariatric Surgery Questionnaire consisting of 30 questions that assess their knowldege in areas of nutrition, physical activity, and bariatric surgery. They will also be given a questionnaire on physical activity (International physical activity questionnaire or IPAQ). The primary objective is to assess improvement on both of these questionnaires with use of app.
measure: Ease of use of app
time frame: 3 months
description: Through a questionnaire provided at the end of study, we will be gathering input from participants regarding ease of use of app, things they would like added or removed, as well as if they found modules helpful.
arm group label: Smartphone Arm
arm group type: Other
description: This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in preparing for bariatric surgery.
intervention type: Behavioral
intervention name: Use of smartphone app
arm group label: Smartphone Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manpreet Mundi, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Manpreet S. Mundi
investigator title: Assistant Professor