<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/NCT03286699</url>
  </required_header>
  <id_info>
    <org_study_id>CA212628</org_study_id>
    <secondary_id>R21CA212628</secondary_id>
    <nct_id>NCT03286699</nct_id>
  </id_info>
  <brief_title>Lifestyle Change for Better Health</brief_title>
  <acronym>LCBH</acronym>
  <official_title>Leukocyte Telomere Length: Diet and Exercise Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the research is to provide a first critical test of the novel scientific idea&#xD;
      that a combined diet and exercise intervention may ameliorate shortening of leukocyte&#xD;
      telomere length (LTL) in individuals with histories of successfully treated non-metastatic&#xD;
      bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)</measure>
    <time_frame>Blood samples will be collected as part of the 6 month assessment</time_frame>
    <description>LTL will be measured in blood samples from participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)</measure>
    <time_frame>Blood samples will be collected as part of the 3 month assessment</time_frame>
    <description>LTL will be measured in blood samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)</measure>
    <time_frame>Blood samples will be collected as part of the 12 month assessment (as feasible)</time_frame>
    <description>LTL will be measured in blood samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telomerase level at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Blood samples will be collected as part of the 3 month assessment</time_frame>
    <description>Telomerase will be measured in blood samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telomerase level at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Blood samples will be collected as part of the 6 month assessment</time_frame>
    <description>Telomerase will be measured in blood samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telomerase level at 12 months (controlling for appropriate covariates)</measure>
    <time_frame>Blood samples will be collected as part of the 12 month assessment (as feasible)</time_frame>
    <description>Telomerase will be measured in blood samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8-OHdG level at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 3 month assessment</time_frame>
    <description>8-OHdG will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8-OHdG level at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 6 month assessment</time_frame>
    <description>8-OHdG will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 3 month assessment</time_frame>
    <description>SOD1 will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 6 month assessment</time_frame>
    <description>SOD1 will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 3 month assessment</time_frame>
    <description>SOD2 will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 6 month assessment</time_frame>
    <description>SOD2 will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 3 month assessment</time_frame>
    <description>Gpx will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 6 month assessment</time_frame>
    <description>Gpx will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 3 month assessment</time_frame>
    <description>SIR will be measured in samples from participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Samples will be collected as part of the 6 month assessment</time_frame>
    <description>SIR will be measured in samples from participants</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 3 month assessment</time_frame>
    <description>BMI will be calculated from height and weight measurements</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 6 month assessment</time_frame>
    <description>BMI will be calculated from height and weight measurements</description>
  </other_outcome>
  <other_outcome>
    <measure>Body composition at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 3 month assessment</time_frame>
    <description>Body composition will be measured by dual-energy x-ray absorptiometry (DXA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Body composition at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 6 month assessment</time_frame>
    <description>Body composition will be measured by dual-energy x-ray absorptiometry (DXA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Regional adiposity (DXA) at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 3 month assessment</time_frame>
    <description>Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Regional adiposity (DXA) at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 6 month assessment</time_frame>
    <description>Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist-to-hip ratio at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 3 month assessment</time_frame>
    <description>Waist-to-hip ratio will be calculated from waist and hip measurements</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist-to-hip ratio at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 6 month assessment</time_frame>
    <description>Waist-to-hip ratio will be calculated from waist and hip measurements</description>
  </other_outcome>
  <other_outcome>
    <measure>Objective physical activity level at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment</time_frame>
    <description>Physical Activity will be objectively measured with SenseWear BodyMedia</description>
  </other_outcome>
  <other_outcome>
    <measure>Objective physical activity level at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment</time_frame>
    <description>Physical Activity will be objectively measured with SenseWear BodyMedia</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported physical activity level at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Self-reports will be obtained as part of the 3 month assessment</time_frame>
    <description>The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported physical activity level at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Self-reports will be obtained as part of the 6 month assessment</time_frame>
    <description>The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiorespiratory fitness at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 3 month assessment</time_frame>
    <description>Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiorespiratory fitness at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Measurements will be collected as part of the 6 month assessment</time_frame>
    <description>Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive symptoms at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 3 month assessment</time_frame>
    <description>The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive symptoms at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 6 month assessment</time_frame>
    <description>The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Symptoms of anxiety at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 3 month assessment</time_frame>
    <description>The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety</description>
  </other_outcome>
  <other_outcome>
    <measure>Symptoms of anxiety at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 6 month assessment</time_frame>
    <description>The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived stress at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 3 month assessment</time_frame>
    <description>The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived stress at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 6 month assessment</time_frame>
    <description>The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep quality at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 3 month assessment</time_frame>
    <description>The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep quality at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 6 month assessment</time_frame>
    <description>The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life at 3 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 3 month assessment</time_frame>
    <description>The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life at 6 months (controlling for appropriate covariates)</measure>
    <time_frame>Questionnaires will be completed as part of the 6 month assessment</time_frame>
    <description>The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Bladder Cancer</condition>
  <condition>Telomere Shortening</condition>
  <condition>Colorectal Adenoma</condition>
  <arm_group>
    <arm_group_label>DIET</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DIET-PA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.</description>
    <arm_group_label>DIET</arm_group_label>
    <arm_group_label>DIET-PA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity Intervention</intervention_name>
    <description>The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact.</description>
    <arm_group_label>DIET-PA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 25.0 to &lt;40 kg/m2 (allows for use of assessments such as DXA to be&#xD;
             included)&#xD;
&#xD;
          -  History of histologically confirmed bladder cancer (non-metastatic) or colorectal&#xD;
             adenoma&#xD;
&#xD;
          -  Under clinical surveillance with no evidence of disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WHO performance status 3-4 or deemed physically unable to participate by physician&#xD;
&#xD;
          -  Currently pregnant or breastfeeding, were pregnant in the previous 6 months or&#xD;
             breastfeeding in the previous 3 months, or planning pregnancy in the next year&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
&#xD;
          -  Medical condition that could affect body weight (e.g., diabetes mellitus,&#xD;
             hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic&#xD;
             liver disease, gastrointestinal disorders including ulcerative colitis)&#xD;
&#xD;
          -  Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the&#xD;
             previous 5 years&#xD;
&#xD;
          -  Current congestive heart failure, signs or symptoms indicative of an increased acute&#xD;
             risk for a cardiovascular event&#xD;
&#xD;
          -  History of myocardial infarction, coronary artery bypass or angioplasty, conditions&#xD;
             requiring chronic anticoagulation (recent or recurrent DVT)&#xD;
&#xD;
          -  Resting systolic blood pressure of &gt;160 mmHg or diastolic blood pressure &gt;100 mmHg&#xD;
&#xD;
          -  Eating disorder that would contraindicate weight loss or physical activity&#xD;
&#xD;
          -  Alcohol or substance abuse&#xD;
&#xD;
          -  Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or&#xD;
             taking daily or extended release psychotropic medications in the previous 12 months&#xD;
&#xD;
          -  Report exercising more than 100 minutes per week over the past 3 months (NOTE:&#xD;
             includes physical activity performed for sport, fitness, or recreational activity;&#xD;
             physical activity performed as part of occupation or household chores is not included)&#xD;
&#xD;
          -  Weight loss of greater than 5% or participating in a weight reduction diet in the past&#xD;
             3 months&#xD;
&#xD;
          -  Report plans to relocate to a location not accessible to the study site or having&#xD;
             employment, personal, or travel commitments that prohibit attendance to at least 80&#xD;
             percent of the scheduled intervention sessions and all of the scheduled assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana Bovbjerg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Jakicic, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Shadyside</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Dana Bovbjerg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT03286699
org study id: CA212628
secondary id: R21CA212628
nct id: NCT03286699
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The goal of the research is to provide a first critical test of the novel scientific idea
      that a combined diet and exercise intervention may ameliorate shortening of leukocyte
      telomere length (LTL) in individuals with histories of successfully treated non-metastatic
      bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
time frame: Blood samples will be collected as part of the 6 month assessment
description: LTL will be measured in blood samples from participants
measure: Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
time frame: Blood samples will be collected as part of the 3 month assessment
description: LTL will be measured in blood samples from participants
measure: Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)
time frame: Blood samples will be collected as part of the 12 month assessment (as feasible)
description: LTL will be measured in blood samples from participants
measure: Telomerase level at 3 months (controlling for appropriate covariates)
time frame: Blood samples will be collected as part of the 3 month assessment
description: Telomerase will be measured in blood samples from participants
measure: Telomerase level at 6 months (controlling for appropriate covariates)
time frame: Blood samples will be collected as part of the 6 month assessment
description: Telomerase will be measured in blood samples from participants
measure: Telomerase level at 12 months (controlling for appropriate covariates)
time frame: Blood samples will be collected as part of the 12 month assessment (as feasible)
description: Telomerase will be measured in blood samples from participants
measure: 8-OHdG level at 3 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 3 month assessment
description: 8-OHdG will be measured in samples from participants
measure: 8-OHdG level at 6 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 6 month assessment
description: 8-OHdG will be measured in samples from participants
measure: Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 3 month assessment
description: SOD1 will be measured in samples from participants
measure: Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 6 month assessment
description: SOD1 will be measured in samples from participants
measure: Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 3 month assessment
description: SOD2 will be measured in samples from participants
measure: Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 6 month assessment
description: SOD2 will be measured in samples from participants
measure: Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 3 month assessment
description: Gpx will be measured in samples from participants
measure: Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 6 month assessment
description: Gpx will be measured in samples from participants
measure: Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 3 month assessment
description: SIR will be measured in samples from participants
measure: Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)
time frame: Samples will be collected as part of the 6 month assessment
description: SIR will be measured in samples from participants
measure: Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 3 month assessment
description: BMI will be calculated from height and weight measurements
measure: Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 6 month assessment
description: BMI will be calculated from height and weight measurements
measure: Body composition at 3 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 3 month assessment
description: Body composition will be measured by dual-energy x-ray absorptiometry (DXA)
measure: Body composition at 6 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 6 month assessment
description: Body composition will be measured by dual-energy x-ray absorptiometry (DXA)
measure: Regional adiposity (DXA) at 3 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 3 month assessment
description: Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)
measure: Regional adiposity (DXA) at 6 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 6 month assessment
description: Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)
measure: Waist-to-hip ratio at 3 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 3 month assessment
description: Waist-to-hip ratio will be calculated from waist and hip measurements
measure: Waist-to-hip ratio at 6 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 6 month assessment
description: Waist-to-hip ratio will be calculated from waist and hip measurements
measure: Objective physical activity level at 3 months (controlling for appropriate covariates)
time frame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment
description: Physical Activity will be objectively measured with SenseWear BodyMedia
measure: Objective physical activity level at 6 months (controlling for appropriate covariates)
time frame: Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment
description: Physical Activity will be objectively measured with SenseWear BodyMedia
measure: Self-reported physical activity level at 3 months (controlling for appropriate covariates)
time frame: Self-reports will be obtained as part of the 3 month assessment
description: The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity
measure: Self-reported physical activity level at 6 months (controlling for appropriate covariates)
time frame: Self-reports will be obtained as part of the 6 month assessment
description: The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity
measure: Cardiorespiratory fitness at 3 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 3 month assessment
description: Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test
measure: Cardiorespiratory fitness at 6 months (controlling for appropriate covariates)
time frame: Measurements will be collected as part of the 6 month assessment
description: Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test
measure: Depressive symptoms at 3 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 3 month assessment
description: The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms
measure: Depressive symptoms at 6 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 6 month assessment
description: The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms
measure: Symptoms of anxiety at 3 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 3 month assessment
description: The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety
measure: Symptoms of anxiety at 6 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 6 month assessment
description: The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety
measure: Perceived stress at 3 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 3 month assessment
description: The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress
measure: Perceived stress at 6 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 6 month assessment
description: The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress
measure: Sleep quality at 3 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 3 month assessment
description: The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality
measure: Sleep quality at 6 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 6 month assessment
description: The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality
measure: Quality of life at 3 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 3 month assessment
description: The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life
measure: Quality of life at 6 months (controlling for appropriate covariates)
time frame: Questionnaires will be completed as part of the 6 month assessment
description: The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life
arm group label: DIET
arm group type: Active Comparator
description: This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant.
arm group label: DIET-PA
arm group type: Active Comparator
description: This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week.
intervention type: Behavioral
intervention name: Dietary Intervention
description: The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.
arm group label: DIET
arm group label: DIET-PA
intervention type: Behavioral
intervention name: Physical Activity Intervention
description: The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact.
arm group label: DIET-PA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: Dana Bovbjerg, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: John Jakicic, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Dana Bovbjerg
investigator title: Professor
mesh term: Adenoma