<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/NCT02252484</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001274</org_study_id>
    <nct_id>NCT02252484</nct_id>
  </id_info>
  <brief_title>Energy Balance for Prostate Cancer Survivorship</brief_title>
  <official_title>Energy Balance for Prostate Cancer Survivorship</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jill Hamilton-Reeves, PhD RD LD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of a weight management program for&#xD;
      men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight&#xD;
      gain, and reduces risk of cancer recurrence in the participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The weight management program is designed to help participants lose weight before their&#xD;
      prostatectomy and to help them maintain that weight loss after surgery. There are four main&#xD;
      components to the weight management program. The four components of the program are:&#xD;
&#xD;
        1. Diet&#xD;
&#xD;
        2. Physical activity&#xD;
&#xD;
        3. Coaching&#xD;
&#xD;
        4. Diet and exercise monitoring tool&#xD;
&#xD;
      The program will be tailored to each individual participant. All participants will be ask to&#xD;
      monitor their program using a tool provided by the study team. Participants will be actively&#xD;
      participating in the study activities for about 5 months. After that, the study team will&#xD;
      review medical records for up to 10 years after enrollment to monitor weight changes and&#xD;
      cancer status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight during the post-surgical period</measure>
    <time_frame>Change from Surgery to Week 20</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight during the pre-surgical weight-loss intervention</measure>
    <time_frame>Change from Baseline to Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diet quality during the pre-surgical weight-loss intervention</measure>
    <time_frame>Change from Baseline to Week 8</time_frame>
    <description>Changes will be measured by analyzing results from alternative healthy eating index scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate cancer status</measure>
    <time_frame>Week 20</time_frame>
    <description>Evidence of recurrence of cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular biomarkers</measure>
    <time_frame>Change from Baseline to Week 20</time_frame>
    <description>Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Weight loss intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weight Loss Program</intervention_name>
    <description>Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.</description>
    <arm_group_label>Weight loss intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care for this patient population.</description>
    <arm_group_label>Comparison Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1&#xD;
             or T2)&#xD;
&#xD;
          -  Body Mass Index (BMI) 25-45 kg/m2&#xD;
&#xD;
          -  Have internet access&#xD;
&#xD;
          -  Have an iPad/iPhone/iDevice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of 5 alpha reductase inhibitors prior 3 months&#xD;
&#xD;
          -  History of radiation therapy&#xD;
&#xD;
          -  Taking active cancer treatment&#xD;
&#xD;
          -  Undergoing salvage therapy&#xD;
&#xD;
          -  Castration-resistant prostate cancer&#xD;
&#xD;
          -  Evidence of metastasis&#xD;
&#xD;
          -  Evidence of biochemical recurrence&#xD;
&#xD;
          -  High risk medical condition (e.g. gout or kidney disease)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill Hamilton-Reeves, PhD, RD, LD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Jill Hamilton-Reeves, PhD RD LD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>prostatectomy</keyword>
  <keyword>weight loss</keyword>
  <keyword>prevent weight gain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT02252484
org study id: STUDY00001274
nct id: NCT02252484
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effectiveness of a weight management program for
      men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight
      gain, and reduces risk of cancer recurrence in the participants.
The weight management program is designed to help participants lose weight before their
      prostatectomy and to help them maintain that weight loss after surgery. There are four main
      components to the weight management program. The four components of the program are:

        1. Diet

        2. Physical activity

        3. Coaching

        4. Diet and exercise monitoring tool

      The program will be tailored to each individual participant. All participants will be ask to
      monitor their program using a tool provided by the study team. Participants will be actively
      participating in the study activities for about 5 months. After that, the study team will
      review medical records for up to 10 years after enrollment to monitor weight changes and
      cancer status.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in body weight during the post-surgical period
time frame: Change from Surgery to Week 20
measure: Changes in body weight during the pre-surgical weight-loss intervention
time frame: Change from Baseline to Week 8
measure: Changes in diet quality during the pre-surgical weight-loss intervention
time frame: Change from Baseline to Week 8
description: Changes will be measured by analyzing results from alternative healthy eating index scores.
measure: Prostate cancer status
time frame: Week 20
description: Evidence of recurrence of cancer
measure: Change in cardiovascular biomarkers
time frame: Change from Baseline to Week 20
description: Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.
arm group label: Weight loss intervention Group
arm group type: Experimental
description: Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.
arm group label: Comparison Group
arm group type: Active Comparator
description: All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
intervention type: Other
intervention name: Weight Loss Program
description: Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.
arm group label: Weight loss intervention Group
intervention type: Other
intervention name: Standard of Care
description: Standard of Care for this patient population.
arm group label: Comparison Group
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 72 Years
healthy volunteers: No
last name: Jill Hamilton-Reeves, PhD, RD, LD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Jill Hamilton-Reeves, PhD RD LD
investigator title: Assistant Professor
mesh term: Prostatic Neoplasms