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/NCT05993169</url>
    </required_header>
    <id_info>
      <org_study_id>202306474</org_study_id>
      <nct_id>NCT05993169</nct_id>
    </id_info>
    <brief_title>Body Composition Optimization Intervention RCT</brief_title>
    <official_title>Body Composition Optimization Intervention to Increase Conversion to Surgical Candidacy: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jacob M. Elkins</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Iowa</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study aims to identify if the addition of structured nutrition/weight loss counseling to&#xD;
        patients at the bariatric clinic can increase the conversion from bariatric clinic to&#xD;
        surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA&#xD;
        measurements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obesity, at a BMI exceeding 40kg/m2 (class III) obesity, is a major risk factor for&#xD;
        osteoarthritis (OA). In arthroplasty (joint replacement), patients in this population are&#xD;
        routinely turned away due to surgeons refusing surgical treatment in patients above arbitrary&#xD;
        BMI thresholds (typically 35 or 40 kg/m2). Due to this, patients often turn to simple weight&#xD;
        loss to fall below these thresholds. Simple weight loss, which can include loss of muscle&#xD;
        mass, has been proven ineffective, counterproductive, and to be an additional risk factor for&#xD;
        surgery. To combat this, efforts in our dedicated bariatric clinic have been made to&#xD;
        encourage muscle mass gain and body fat loss over simple weight loss methods where progress&#xD;
        has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a&#xD;
        readily available technology offered to industry and consumers. Our department is a novel&#xD;
        clinic aimed at holistically serving the osteoarthritic-class III obese population for&#xD;
        controlled and monitored weight loss through BIA.&#xD;
  &#xD;
        This study is a randomized controlled trial which aims to recruit adult patients with class&#xD;
        III obesity who present to the bariatric arthroplasty clinic. While all patients will receive&#xD;
        individual body composition coaching to increase muscle mass and decrease body fat mass (as&#xD;
        standard of care in this clinic), study participants will be randomly assigned to one of two&#xD;
        cohorts: the study group who will receive nutritional and exercise consultation/intervention,&#xD;
        or the control group who will only receive the individual body composition coaching that is&#xD;
        standard practice at the bariatric clinic.&#xD;
  &#xD;
        This study aims to identify if the addition of structured nutrition/weight loss counseling to&#xD;
        patients at the bariatric clinic can increase the conversion from bariatric clinic to&#xD;
        surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA&#xD;
        measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">July 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 18, 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>Treatment</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>Primary care provider will be blind to subject arm,</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Weight (in kg)</measure>
      <time_frame>1 year</time_frame>
      <description>Patient weight will be recorded at each visit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Height (in cm)</measure>
      <time_frame>1 year</time_frame>
      <description>Patient height will be recorded at each visit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body mass index</measure>
      <time_frame>1 year</time_frame>
      <description>Patient BMI will be calculated by (weight in kg/height in meters squared)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hand grip strength (measured in kg)</measure>
      <time_frame>1 year</time_frame>
      <description>Hand grip strength will be obtained at each visit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body fat mass</measure>
      <time_frame>1 year</time_frame>
      <description>Body fat mass will be obtained by an InBody machine at each visit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skeletal muscle mass</measure>
      <time_frame>1 year</time_frame>
      <description>Skeletal Muscle mass will be obtained by an InBody machine at each visit</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Obesity, Morbid</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Normal Care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nutritional consultation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Body Composition optimization visits</intervention_name>
      <description>Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.</description>
      <arm_group_label>Nutritional consultation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Adults, at or above 18 years of age&#xD;
  &#xD;
            -  BMI over 40kg/m2&#xD;
  &#xD;
            -  Presenting to arthroplasty-obesity clinic with desire for a total joint arthroplasty&#xD;
               procedure&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Has a pacemaker or other electronic pacemaker placement&#xD;
  &#xD;
            -  Inability to stand unsupported for 60-90 seconds&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jacob Elkins, MD, PHD</last_name>
      <phone>+1 319 335 7529</phone>
      <email>jacob-elkins@uiowa.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Iowa Hospitals and Clinics</name>
        <address>
          <city>Iowa City</city>
          <state>Iowa</state>
          <zip>52242</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacob Elkins, MD, PhD</last_name>
        <email>jacob-elkins@uiowa.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Iowa</investigator_affiliation>
      <investigator_full_name>Jacob M. Elkins</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Morbid</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/NCT05993169
  org study id: 202306474
  nct id: NCT05993169
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to identify if the addition of structured nutrition/weight loss counseling to
        patients at the bariatric clinic can increase the conversion from bariatric clinic to
        surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA
        measurements.
  Obesity, at a BMI exceeding 40kg/m2 (class III) obesity, is a major risk factor for
        osteoarthritis (OA). In arthroplasty (joint replacement), patients in this population are
        routinely turned away due to surgeons refusing surgical treatment in patients above arbitrary
        BMI thresholds (typically 35 or 40 kg/m2). Due to this, patients often turn to simple weight
        loss to fall below these thresholds. Simple weight loss, which can include loss of muscle
        mass, has been proven ineffective, counterproductive, and to be an additional risk factor for
        surgery. To combat this, efforts in our dedicated bariatric clinic have been made to
        encourage muscle mass gain and body fat loss over simple weight loss methods where progress
        has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a
        readily available technology offered to industry and consumers. Our department is a novel
        clinic aimed at holistically serving the osteoarthritic-class III obese population for
        controlled and monitored weight loss through BIA.
  
        This study is a randomized controlled trial which aims to recruit adult patients with class
        III obesity who present to the bariatric arthroplasty clinic. While all patients will receive
        individual body composition coaching to increase muscle mass and decrease body fat mass (as
        standard of care in this clinic), study participants will be randomly assigned to one of two
        cohorts: the study group who will receive nutritional and exercise consultation/intervention,
        or the control group who will only receive the individual body composition coaching that is
        standard practice at the bariatric clinic.
  
        This study aims to identify if the addition of structured nutrition/weight loss counseling to
        patients at the bariatric clinic can increase the conversion from bariatric clinic to
        surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA
        measurements.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  masking description: Primary care provider will be blind to subject arm,
  measure: Weight (in kg)
  time frame: 1 year
  description: Patient weight will be recorded at each visit
  measure: Height (in cm)
  time frame: 1 year
  description: Patient height will be recorded at each visit
  measure: Body mass index
  time frame: 1 year
  description: Patient BMI will be calculated by (weight in kg/height in meters squared)
  measure: Hand grip strength (measured in kg)
  time frame: 1 year
  description: Hand grip strength will be obtained at each visit
  measure: Body fat mass
  time frame: 1 year
  description: Body fat mass will be obtained by an InBody machine at each visit
  measure: Skeletal muscle mass
  time frame: 1 year
  description: Skeletal Muscle mass will be obtained by an InBody machine at each visit
  arm group label: Control
  arm group type: No Intervention
  description: Normal Care
  arm group label: Nutritional consultation
  arm group type: Experimental
  description: Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.
  intervention type: Other
  intervention name: Body Composition optimization visits
  description: Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.
  arm group label: Nutritional consultation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Jacob Elkins, MD, PHD
  phone: +1 319 335 7529
  email: jacob-elkins@uiowa.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Iowa
  investigator full name: Jacob M. Elkins
  investigator title: Assistant Professor
  mesh term: Obesity, Morbid