<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/NCT02986243</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-1593</org_study_id>
    <nct_id>NCT02986243</nct_id>
  </id_info>
  <brief_title>Preparing for Kidney Transplant by Attaining a Healthy Weight</brief_title>
  <acronym>FFC</acronym>
  <official_title>Preparing for Kidney Transplant by Attaining a Healthy Weight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if an assigned physical fitness program will result&#xD;
      in weight loss to prepare patients for kidney transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to prepare subjects for kidney transplant. Patients who are in need&#xD;
      of a kidney transplant but are unable to be place on the wait list due to weight will be&#xD;
      enrolled in a six month workout program. The workout program will consist of counseling from&#xD;
      a registered dietician, personal training from certified trainers and constant health&#xD;
      monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>6 months</time_frame>
    <description>The difference in starting weight and ending weight six months after beginning exercise program will be measured.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Kidney Transplant</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive a diet plan and exercise regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>6 months worth of exercise regimen</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Diet Plan</intervention_name>
    <description>Each subject will receive a personalized diet plan from nutritionist.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over 18 years of age and older but less than 65&#xD;
&#xD;
          -  All patients who are currently listed as &quot;inactive&quot; on the University of Chicago&#xD;
             kidney transplant wait list&#xD;
&#xD;
          -  Those with a body mass index of 40-44&#xD;
&#xD;
          -  Those with access to the Internet&#xD;
&#xD;
          -  Have transportation to the fitness center (Formula Fitness Center at Union Station&#xD;
             location)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those patients who are listed &quot;inactive&quot; on the wait-list due to co-morbid conditions&#xD;
             other than obesity&#xD;
&#xD;
          -  Those who are unwilling to attend fitness center appointments&#xD;
&#xD;
          -  Those who do not have adequate transportation to the fitness center&#xD;
&#xD;
          -  Those who do not have access to the Internet&#xD;
&#xD;
          -  Those who are not comfortable navigating and using the Internet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02986243
org study id: IRB15-1593
nct id: NCT02986243
lead sponsor: 
has dmc: No
The purpose of this study is to determine if an assigned physical fitness program will result
      in weight loss to prepare patients for kidney transplant.
The goal of this study is to prepare subjects for kidney transplant. Patients who are in need
      of a kidney transplant but are unable to be place on the wait list due to weight will be
      enrolled in a six month workout program. The workout program will consist of counseling from
      a registered dietician, personal training from certified trainers and constant health
      monitoring.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Loss
time frame: 6 months
description: The difference in starting weight and ending weight six months after beginning exercise program will be measured.
arm group label: Treatment
arm group type: Experimental
description: Subjects receive a diet plan and exercise regimen.
intervention type: Other
intervention name: Exercise
description: 6 months worth of exercise regimen
arm group label: Treatment
intervention type: Dietary Supplement
intervention name: Diet Plan
description: Each subject will receive a personalized diet plan from nutritionist.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No