xml: <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/NCT05986617</url>
    </required_header>
    <id_info>
      <org_study_id>202207288</org_study_id>
      <nct_id>NCT05986617</nct_id>
    </id_info>
    <brief_title>Wearable Bioimpedance Analyzer for Tracking Body Composition Changes</brief_title>
    <official_title>Wearable Bioimpedance Analyzer for Tracking Body Composition Changes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Iowa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Iowa</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>
        Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a&#xD;
        risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in&#xD;
        this population frequently present for and are turned away from surgical intervention.&#xD;
        Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have&#xD;
        been suggested as ineffective and counterproductive. Furthermore, simple weight loss may&#xD;
        include muscle mass loss, which is an additional risk factor for surgery. At the University&#xD;
        of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage&#xD;
        muscle mass gain and body fat loss over simple weight loss where progress has been tracked&#xD;
        through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available&#xD;
        technology offered to industry and consumers, and BIA has recently been incorporated into&#xD;
        wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically&#xD;
        serving the osteoarthritic-class III obese population for controlled and monitored weight&#xD;
        loss through BIA.&#xD;
  &#xD;
        This study, a randomized controlled trial, aims to recruit adult patients with class III&#xD;
        obesity presenting to the arthroplasty-obesity clinic. While all patients will receive&#xD;
        individual body composition coaching to increase muscle mass and decrease body fat mass, they&#xD;
        will be randomized to one of two cohorts: the study group will receive a wearable BIA&#xD;
        wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching,&#xD;
        and the control group will only receive the standard coaching.&#xD;
  &#xD;
        This study aims to identify if the use of a wearable BIA wristband aids in the desired body&#xD;
        composition changes. In addition, this study aims to quantify the body composition changes&#xD;
        exhibited by each cohort. Finally, this study aims to track surgical outcomes for those&#xD;
        patients that are indicated for total joint arthroplasty.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 14, 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2025</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>Other</primary_purpose>
      <masking>Double (Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of body composition changes</measure>
      <time_frame>Maximum 12 months prior to TJA</time_frame>
      <description>To identify if the use of a wearable BIA wristband has any effect on the rate of desired body composition changes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgical Outcomes</measure>
      <time_frame>24 months postoperatively</time_frame>
      <description>Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition changes quantified</measure>
      <time_frame>Maximum 12 months prior to TJA</time_frame>
      <description>Body mass change, fat mass change, skeletal muscle mass change</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Obesity</condition>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Wearable Device Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>InBody Band 2</intervention_name>
      <description>Wearable bioimpediance monitor similar to a fitness watch.</description>
      <arm_group_label>Wearable Device Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt;/= 18 years&#xD;
  &#xD;
            -  BMI &gt; 40kg/m2&#xD;
  &#xD;
            -  Presenting to arthroplasty-obesity clinic with desire for total joint arthroplasty&#xD;
               procedure&#xD;
  &#xD;
            -  Owns a smartphone capable of handling iOS or Google Play apps.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a pacemaker or other electronic pacemaker placement&#xD;
  &#xD;
            -  Inability to complete study protocols&#xD;
  &#xD;
            -  Inability to stand unsupported for 60-90 seconds&#xD;
  &#xD;
            -  Does not own a smart phone&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Iowa Hospitals &amp; Clinics</name>
        <address>
          <city>Iowa City</city>
          <state>Iowa</state>
          <zip>52242</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.</citation>
      <PMID>11234459</PMID>
    </reference>
    <reference>
      <citation>Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty. 2013 May;28(5):714-21. doi: 10.1016/j.arth.2013.02.011. Epub 2013 Mar 19.</citation>
      <PMID>23518425</PMID>
    </reference>
    <reference>
      <citation>Andrew JG, Palan J, Kurup HV, Gibson P, Murray DW, Beard DJ. Obesity in total hip replacement. J Bone Joint Surg Br. 2008 Apr;90(4):424-9. doi: 10.1302/0301-620X.90B4.20522.</citation>
      <PMID>18378913</PMID>
    </reference>
    <reference>
      <citation>DeMik DE, Bedard NA, Dowdle SB, Elkins JM, Brown TS, Gao Y, Callaghan JJ. Complications and Obesity in Arthroplasty-A Hip is Not a Knee. J Arthroplasty. 2018 Oct;33(10):3281-3287. doi: 10.1016/j.arth.2018.02.073. Epub 2018 Feb 26.</citation>
      <PMID>29631859</PMID>
    </reference>
    <reference>
      <citation>Foreman CW, Callaghan JJ, Brown TS, Elkins JM, Otero JE. Total Joint Arthroplasty in the Morbidly Obese: How Body Mass Index &gt;/=40 Influences Patient Retention, Treatment Decisions, and Treatment Outcomes. J Arthroplasty. 2020 Jan;35(1):39-44. doi: 10.1016/j.arth.2019.08.019. Epub 2019 Aug 17.</citation>
      <PMID>31530460</PMID>
    </reference>
    <reference>
      <citation>Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The impact of pre-operative weight loss on incidence of surgical site infection and readmission rates after total joint arthroplasty. J Arthroplasty. 2014 Mar;29(3):458-64.e1. doi: 10.1016/j.arth.2013.07.030. Epub 2013 Sep 7.</citation>
      <PMID>24018161</PMID>
    </reference>
    <reference>
      <citation>Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The risk of surgical site infection and re-admission in obese patients undergoing total joint replacement who lose weight before surgery and keep it off post-operatively. Bone Joint J. 2014 May;96-B(5):629-35. doi: 10.1302/0301-620X.96B5.33136.</citation>
      <PMID>24788497</PMID>
    </reference>
    <reference>
      <citation>Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.</citation>
      <PMID>23670675</PMID>
    </reference>
    <reference>
      <citation>Ward LC, Dyer JM, Byrne NM, Sharpe KK, Hills AP. Validation of a three-frequency bioimpedance spectroscopic method for body composition analysis. Nutrition. 2007 Sep;23(9):657-64. doi: 10.1016/j.nut.2007.06.009.</citation>
      <PMID>17679047</PMID>
    </reference>
    <reference>
      <citation>Milone MT, Shenoy K, Pham H, Jazrawi LM, Strauss EJ. MRI analysis of peripheral soft tissue composition, not body mass index, correlates with outcomes following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2018 Dec;26(12):3711-3716. doi: 10.1007/s00167-018-4966-7. Epub 2018 May 3.</citation>
      <PMID>29725746</PMID>
    </reference>
    <reference>
      <citation>Muller M, Tohtz S, Winkler T, Dewey M, Springer I, Perka C. MRI findings of gluteus minimus muscle damage in primary total hip arthroplasty and the influence on clinical outcome. Arch Orthop Trauma Surg. 2010 Jul;130(7):927-35. doi: 10.1007/s00402-010-1085-4. Epub 2010 Mar 11.</citation>
      <PMID>20221834</PMID>
    </reference>
    <reference>
      <citation>Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.</citation>
      <PMID>23188719</PMID>
    </reference>
    <reference>
      <citation>Qin ES, Bowen MJ, James SL, Chen WF. Multi-segment bioimpedance can assess patients with bilateral lymphedema. J Plast Reconstr Aesthet Surg. 2020 Feb;73(2):328-336. doi: 10.1016/j.bjps.2019.06.041. Epub 2019 Aug 7.</citation>
      <PMID>31515193</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Iowa</investigator_affiliation>
      <investigator_full_name>Jacob M. Elkins</investigator_full_name>
      <investigator_title>Assistant Professor of Orthopedics and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>total knee replacement</keyword>
    <keyword>obesity</keyword>
    <keyword>total joint replacement</keyword>
    <keyword>bioimpedance</keyword>
    <keyword>orthopedics</keyword>
    <keyword>body composition</keyword>
    <keyword>fitness tracker</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986617
  org study id: 202207288
  nct id: NCT05986617
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a
        risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in
        this population frequently present for and are turned away from surgical intervention.
        Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have
        been suggested as ineffective and counterproductive. Furthermore, simple weight loss may
        include muscle mass loss, which is an additional risk factor for surgery. At the University
        of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage
        muscle mass gain and body fat loss over simple weight loss where progress has been tracked
        through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available
        technology offered to industry and consumers, and BIA has recently been incorporated into
        wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically
        serving the osteoarthritic-class III obese population for controlled and monitored weight
        loss through BIA.
  
        This study, a randomized controlled trial, aims to recruit adult patients with class III
        obesity presenting to the arthroplasty-obesity clinic. While all patients will receive
        individual body composition coaching to increase muscle mass and decrease body fat mass, they
        will be randomized to one of two cohorts: the study group will receive a wearable BIA
        wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching,
        and the control group will only receive the standard coaching.
  
        This study aims to identify if the use of a wearable BIA wristband aids in the desired body
        composition changes. In addition, this study aims to quantify the body composition changes
        exhibited by each cohort. Finally, this study aims to track surgical outcomes for those
        patients that are indicated for total joint arthroplasty.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Care Provider, Investigator)
  measure: Rate of body composition changes
  time frame: Maximum 12 months prior to TJA
  description: To identify if the use of a wearable BIA wristband has any effect on the rate of desired body composition changes.
  measure: Surgical Outcomes
  time frame: 24 months postoperatively
  description: Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication.
  measure: Body composition changes quantified
  time frame: Maximum 12 months prior to TJA
  description: Body mass change, fat mass change, skeletal muscle mass change
  arm group label: Wearable Device Group
  arm group type: Experimental
  description: Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
  arm group label: Control Group
  arm group type: No Intervention
  description: Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
  intervention type: Device
  intervention name: InBody Band 2
  description: Wearable bioimpediance monitor similar to a fitness watch.
  arm group label: Wearable Device Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  facility: 
  country: United States
  citation: Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
  PMID: 11234459
  citation: Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty. 2013 May;28(5):714-21. doi: 10.1016/j.arth.2013.02.011. Epub 2013 Mar 19.
  PMID: 23518425
  citation: Andrew JG, Palan J, Kurup HV, Gibson P, Murray DW, Beard DJ. Obesity in total hip replacement. J Bone Joint Surg Br. 2008 Apr;90(4):424-9. doi: 10.1302/0301-620X.90B4.20522.
  PMID: 18378913
  citation: DeMik DE, Bedard NA, Dowdle SB, Elkins JM, Brown TS, Gao Y, Callaghan JJ. Complications and Obesity in Arthroplasty-A Hip is Not a Knee. J Arthroplasty. 2018 Oct;33(10):3281-3287. doi: 10.1016/j.arth.2018.02.073. Epub 2018 Feb 26.
  PMID: 29631859
  citation: Foreman CW, Callaghan JJ, Brown TS, Elkins JM, Otero JE. Total Joint Arthroplasty in the Morbidly Obese: How Body Mass Index >/=40 Influences Patient Retention, Treatment Decisions, and Treatment Outcomes. J Arthroplasty. 2020 Jan;35(1):39-44. doi: 10.1016/j.arth.2019.08.019. Epub 2019 Aug 17.
  PMID: 31530460
  citation: Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The impact of pre-operative weight loss on incidence of surgical site infection and readmission rates after total joint arthroplasty. J Arthroplasty. 2014 Mar;29(3):458-64.e1. doi: 10.1016/j.arth.2013.07.030. Epub 2013 Sep 7.
  PMID: 24018161
  citation: Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The risk of surgical site infection and re-admission in obese patients undergoing total joint replacement who lose weight before surgery and keep it off post-operatively. Bone Joint J. 2014 May;96-B(5):629-35. doi: 10.1302/0301-620X.96B5.33136.
  PMID: 24788497
  citation: Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.
  PMID: 23670675
  citation: Ward LC, Dyer JM, Byrne NM, Sharpe KK, Hills AP. Validation of a three-frequency bioimpedance spectroscopic method for body composition analysis. Nutrition. 2007 Sep;23(9):657-64. doi: 10.1016/j.nut.2007.06.009.
  PMID: 17679047
  citation: Milone MT, Shenoy K, Pham H, Jazrawi LM, Strauss EJ. MRI analysis of peripheral soft tissue composition, not body mass index, correlates with outcomes following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2018 Dec;26(12):3711-3716. doi: 10.1007/s00167-018-4966-7. Epub 2018 May 3.
  PMID: 29725746
  citation: Muller M, Tohtz S, Winkler T, Dewey M, Springer I, Perka C. MRI findings of gluteus minimus muscle damage in primary total hip arthroplasty and the influence on clinical outcome. Arch Orthop Trauma Surg. 2010 Jul;130(7):927-35. doi: 10.1007/s00402-010-1085-4. Epub 2010 Mar 11.
  PMID: 20221834
  citation: Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.
  PMID: 23188719
  citation: Qin ES, Bowen MJ, James SL, Chen WF. Multi-segment bioimpedance can assess patients with bilateral lymphedema. J Plast Reconstr Aesthet Surg. 2020 Feb;73(2):328-336. doi: 10.1016/j.bjps.2019.06.041. Epub 2019 Aug 7.
  PMID: 31515193
  responsible party type: Principal Investigator
  investigator affiliation: University of Iowa
  investigator full name: Jacob M. Elkins
  investigator title: Assistant Professor of Orthopedics and Rehabilitation
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee