<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/NCT02239939</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00028928</org_study_id>
    <nct_id>NCT02239939</nct_id>
  </id_info>
  <brief_title>Arthritis Pilot for Preserving Muscle While Losing Weight</brief_title>
  <acronym>APPLE</acronym>
  <official_title>Weighted Vest Use to Preserve Muscle and Bone During Obesity Treatment for Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medifast, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
      The purpose of this research study is to see whether wearing a weighted vest during a period&#xD;
      of active weight loss can decrease the loss of muscle and bone that occurs during weight&#xD;
      loss. We will also determine if study participants who wear the weighted vest will have&#xD;
      greater improvements in physical function and self-reported disability, pain, stiffness,&#xD;
      fatigue and quality of life. This knowledge could impact weight loss programs designed for&#xD;
      older adults.&#xD;
&#xD;
      Hypothesis: Participants randomized to VEST will experience similar weight loss, but less&#xD;
      loss of lean mass and bone density, than participants randomized to Control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The loss of muscle mass and bone density during weight loss is partially attributed to the&#xD;
      decrease in mechanical stress on these tissues as weight is reduced. As a result, performing&#xD;
      exercises that enhance muscle and gravitational loading during the period of caloric&#xD;
      restriction usually diminishes the relative amount of muscle and bone loss for a given weight&#xD;
      loss, but these interventions do not fully prevent all muscle and bone loss.In addition,&#xD;
      conventional exercise training interventions often require expensive equipment, on-site&#xD;
      participation, and, ideally for older, obese adults, safety supervision by trained exercise&#xD;
      leaders. Moreover, the exercises performed may not fully translate into improvement in daily&#xD;
      tasks due to training specificity, and are not always tolerated or sustained, especially in&#xD;
      obese persons with OA. On the other hand, it is conceivable that treating the decrease in&#xD;
      mechanical load from weight loss by externally replacing lost weight via use of a weighted&#xD;
      vest may also be effective for reducing muscle and bone loss during caloric restriction. In&#xD;
      animal models, mechanisms regulating skeletal tissue structure and function respond in a&#xD;
      similar fashion to increases in actual or externally-added body mass. Also, research shows&#xD;
      that exercising while wearing weighted vests can improve bone density, muscle mass, and lower&#xD;
      extremity strength in older adults. However, no prior studies have examined the effects of&#xD;
      weighted vest use on muscle mass and bone density during a period of intentional weight loss.&#xD;
&#xD;
      The main objective of this pilot study is to assess feasibility (accrual, retention,&#xD;
      compliance) of daily use of a weighted vest during a diet intervention, to estimate the&#xD;
      variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A&#xD;
      controlled, randomized design will be used so we can obtain a realistic estimate of accrual&#xD;
      and an unbiased estimate of treatment efficacy.&#xD;
&#xD;
      A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with&#xD;
      x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10%&#xD;
      weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or&#xD;
      2) Progressive weighted vest use during normal daily activities (VEST).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Lean Mass Measured by DXA</measure>
    <time_frame>Baseline and 22 weeks</time_frame>
    <description>Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hip Bone Density</measure>
    <time_frame>Basleine and 22 weeks</time_frame>
    <description>Hip bone density as measured by DXA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)</measure>
    <time_frame>baseline and 22 weeks</time_frame>
    <description>Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where &quot;0' equals no fatigue at all, and &quot;5&quot; equals extreme fatigue.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline and 22 weeks</time_frame>
    <description>Body weight</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Lower Extremity Physical Function</measure>
    <time_frame>Baseline and 22 weeks</time_frame>
    <description>SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Obesity</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Vest + Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Vest + Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vest</intervention_name>
    <description>light weight, adjustable, vest to be worn underneath clothes that weight can be added to</description>
    <arm_group_label>Vest + Diet</arm_group_label>
    <other_name>Hyperwear Vest Pro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
    <arm_group_label>No Vest + Diet</arm_group_label>
    <arm_group_label>Vest + Diet</arm_group_label>
    <other_name>Medifast 4&amp;2&amp;1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI=30-40 kg/m2; Wt&lt;135 kg,&#xD;
&#xD;
          -  self- reported MD diagnosis of osteoarthritis&#xD;
&#xD;
          -  No evidence of clinical depression or other contraindications for participation in&#xD;
             voluntary weight loss,&#xD;
&#xD;
          -  Sedentary lifestyle (&lt;30 min, 3 d/wk of exercise),&#xD;
&#xD;
          -  Able to provide own transportation to study visits and intervention,&#xD;
&#xD;
          -  Not dependent on a cane or walker,&#xD;
&#xD;
          -  Willing and able to consume meal replacement products,&#xD;
&#xD;
          -  Not involved in other research study,&#xD;
&#xD;
          -  Approved for participation by Medical Director,&#xD;
&#xD;
          -  Willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight loss or gain (±5%) in past 6 mos,&#xD;
&#xD;
          -  Excessive alcohol use (&gt; 14 drinks/wk),&#xD;
&#xD;
          -  Smoker (&gt;1 cigarette/d or 4/wk within yr),&#xD;
&#xD;
          -  Evidence of cognitive impairment (MoCA score &lt;22) or difficulty with hearing or vision&#xD;
             that would interfere with study participation, Insulin-dependent or uncontrolled&#xD;
             diabetes (FBG &gt;125 mg/dl) or Hypertriglyceridemia (TG&gt;400 mg/dl),&#xD;
&#xD;
          -  Osteoporosis (T-score&lt; -2.5 on hip or spine); Hip fracture, joint replacement, or&#xD;
             spinal surgery in past 6 mos, or hyperkyphosis,&#xD;
&#xD;
          -  Uncontrolled hypertension (BP&gt;160/90 mmHg) or abnormal kidney or liver tests per&#xD;
             Medical Director discretion,&#xD;
&#xD;
          -  Self- reported hepatitis B or C,&#xD;
&#xD;
          -  Severe anemia (Hb&lt;10 g/100 ml),&#xD;
&#xD;
          -  Past or current uncontrolled endocrine/metabolic disease, neurological or&#xD;
             hematological disease, fibromyalgia, chronic pulmonary disease, hyperparathyroidism,&#xD;
             rheumatoid arthritis, unstable angina, MI, cardiac surgery within 3 months,&#xD;
&#xD;
          -  Cancer requiring treatment in past year except non-melanoma skin cancers,&#xD;
&#xD;
          -  Regular use of medications that may influence body weight, hormones, weight loss&#xD;
             medications, bone remodeling medication, prior use of medications that affect bone,&#xD;
             insulin-dependent,&#xD;
&#xD;
          -  Unable to tolerate vest run-in.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara J. Nicklas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Health Sticht Center on Aging</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>April 3, 2017</results_first_submitted>
  <results_first_submitted_qc>July 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2018</results_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>older adults, body composition, weight loss, muscle mass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vest + Diet</title>
          <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
        </group>
        <group group_id="P2">
          <title>No Vest + Diet</title>
          <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vest + Diet</title>
          <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
        </group>
        <group group_id="B2">
          <title>No Vest + Diet</title>
          <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.3" spread="3.4"/>
                    <measurement group_id="B2" value="69.9" spread="2.6"/>
                    <measurement group_id="B3" value="70.1" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Lean Mass Measured by DXA</title>
        <description>Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).</description>
        <time_frame>Baseline and 22 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diet+Vest</title>
            <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
          <group group_id="O2">
            <title>No Vest+Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lean Mass Measured by DXA</title>
          <description>Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).</description>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="1.6"/>
                    <measurement group_id="O2" value="-2.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hip Bone Density</title>
        <description>Hip bone density as measured by DXA.</description>
        <time_frame>Basleine and 22 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
          <group group_id="O2">
            <title>No Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hip Bone Density</title>
          <description>Hip bone density as measured by DXA.</description>
          <units>g/cm2</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.1" lower_limit="-15.7" upper_limit="3.5"/>
                    <measurement group_id="O2" value="-18.7" lower_limit="-29.3" upper_limit="-8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)</title>
        <description>Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where &quot;0' equals no fatigue at all, and &quot;5&quot; equals extreme fatigue.</description>
        <time_frame>baseline and 22 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
          <group group_id="O2">
            <title>No Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)</title>
          <description>Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where &quot;0' equals no fatigue at all, and &quot;5&quot; equals extreme fatigue.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="13.6"/>
                    <measurement group_id="O2" value="12.3" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Body Weight</title>
        <description>Body weight</description>
        <time_frame>Baseline and 22 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
          <group group_id="O2">
            <title>No Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>Body weight</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-110.6" spread="5.7"/>
                    <measurement group_id="O2" value="-10.9" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Lower Extremity Physical Function</title>
        <description>SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.</description>
        <time_frame>Baseline and 22 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
          <group group_id="O2">
            <title>No Vest + Diet</title>
            <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Lower Extremity Physical Function</title>
          <description>SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.34"/>
                    <measurement group_id="O2" value="0.15" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>26 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vest + Diet</title>
          <description>All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for &gt;10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.&#xD;
Vest: light weight, adjustable, vest to be worn underneath clothes that weight can be added to&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
        </group>
        <group group_id="E2">
          <title>No Vest + Diet</title>
          <description>All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.&#xD;
Diet: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>chest pain</sub_title>
                <description>participant had chest pain. Went to hospital and ended up having a blockage that required a stent</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diverticulitis</sub_title>
                <description>participant had history of diverticulitis since 1980s until 11/2013 which was cleared by antibiotics. With this episode, participant when to doctor as soon as symptoms started.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>dehydration</sub_title>
                <description>Participant became dehydrated after another illness. participant felt it was due to medications- sudafed and mucinex. Participant was hospitalized overnight.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>bronchitis</sub_title>
                <description>Was seen in the Emergency room for bronchitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>dizzy while standing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>lesion removed from under eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhea/nausea/stomach virus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>oxygen level drops at night</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>drug reaction to sulfamethaxayole</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>lower lip swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>back spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>pulled back muscle/ back pain/ neck pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tripped and fell</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>compression fracture in spine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>twisted knee</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>injured by fallen debri</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>fracture in ankle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>knee pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>pulled muscle in shoulder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>tingling/numbness in back/arm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>spinal column pressing on nerves</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>pinch in back</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>bronchitis/pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>sinus infection/cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>gout flare up</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>vericous vein swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Barbara Nicklas</name_or_title>
      <organization>WFSM</organization>
      <phone>3367138569</phone>
      <email>bnicklas@wakehealth.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02239939
org study id: IRB00028928
nct id: NCT02239939
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to see whether wearing a weighted vest during a period
      of active weight loss can decrease the loss of muscle and bone that occurs during weight
      loss. We will also determine if study participants who wear the weighted vest will have
      greater improvements in physical function and self-reported disability, pain, stiffness,
      fatigue and quality of life. This knowledge could impact weight loss programs designed for
      older adults.

      Hypothesis: Participants randomized to VEST will experience similar weight loss, but less
      loss of lean mass and bone density, than participants randomized to Control.
The loss of muscle mass and bone density during weight loss is partially attributed to the
      decrease in mechanical stress on these tissues as weight is reduced. As a result, performing
      exercises that enhance muscle and gravitational loading during the period of caloric
      restriction usually diminishes the relative amount of muscle and bone loss for a given weight
      loss, but these interventions do not fully prevent all muscle and bone loss.In addition,
      conventional exercise training interventions often require expensive equipment, on-site
      participation, and, ideally for older, obese adults, safety supervision by trained exercise
      leaders. Moreover, the exercises performed may not fully translate into improvement in daily
      tasks due to training specificity, and are not always tolerated or sustained, especially in
      obese persons with OA. On the other hand, it is conceivable that treating the decrease in
      mechanical load from weight loss by externally replacing lost weight via use of a weighted
      vest may also be effective for reducing muscle and bone loss during caloric restriction. In
      animal models, mechanisms regulating skeletal tissue structure and function respond in a
      similar fashion to increases in actual or externally-added body mass. Also, research shows
      that exercising while wearing weighted vests can improve bone density, muscle mass, and lower
      extremity strength in older adults. However, no prior studies have examined the effects of
      weighted vest use on muscle mass and bone density during a period of intentional weight loss.

      The main objective of this pilot study is to assess feasibility (accrual, retention,
      compliance) of daily use of a weighted vest during a diet intervention, to estimate the
      variability of outcome measures, and to obtain preliminary estimates of treatment efficacy. A
      controlled, randomized design will be used so we can obtain a realistic estimate of accrual
      and an unbiased estimate of treatment efficacy.

      A total of 36 older (age=65-79 yrs), obese (BMI=30-40 kg/m2), sedentary men and women with
      x-ray evidence of knee OA will undergo a 22 week weight loss intervention (targeting 10%
      weight loss) with randomization to one of two groups (n=18/grp): 1) No vest use (Control); or
      2) Progressive weighted vest use during normal daily activities (VEST).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Lean Mass Measured by DXA
time frame: Baseline and 22 weeks
description: Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).
measure: Change in Hip Bone Density
time frame: Basleine and 22 weeks
description: Hip bone density as measured by DXA.
measure: Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)
time frame: baseline and 22 weeks
description: Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where "0' equals no fatigue at all, and "5" equals extreme fatigue.
measure: Change in Body Weight
time frame: Baseline and 22 weeks
description: Body weight
measure: Changes in Lower Extremity Physical Function
time frame: Baseline and 22 weeks
description: SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
arm group label: Vest + Diet
arm group type: Experimental
description: All participants will undergo a 22 week dietary weight loss. In addition, participants will be asked to wear a weighted vest for >10 hours a day. Weight in the vest is adjusted to match weight lost during the intervention.
arm group label: No Vest + Diet
arm group type: Active Comparator
description: All participants will undergo a 22 week dietary weight loss intervention. Participants in this group will be asked not to change their daily habits other than adherence to the diet protocol.
intervention type: Behavioral
intervention name: Vest
description: light weight, adjustable, vest to be worn underneath clothes that weight can be added to
arm group label: Vest + Diet
other name: Hyperwear Vest Pro
intervention type: Behavioral
intervention name: Diet
description: Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
arm group label: No Vest + Diet
arm group label: Vest + Diet
other name: Medifast 4&2&1
criteria: 
gender: All
minimum age: 65 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara J. Nicklas, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Obesity
sharing ipd: Yes
ipd description: All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 