<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/NCT03816150</url>
  </required_header>
  <id_info>
    <org_study_id>25912</org_study_id>
    <nct_id>NCT03816150</nct_id>
  </id_info>
  <brief_title>Reduce Sedentary Behavior at Work</brief_title>
  <official_title>Interventions to Reduce Sedentary Behavior at Work: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</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>
      Prior research suggests that sedentary behavior is detrimental to health, independent of&#xD;
      exercise activity. Sedentary behavior is defined as behaviors that involve low levels of&#xD;
      energy expenditure ≤1.5 metabolic equivalents (including sitting, watching TV, reading, and&#xD;
      driving). Due to the high burden of sedentary behaviors in modern-day societies, this has&#xD;
      potential implications for novel intervention strategies to reduce sitting (outside of&#xD;
      regular exercise activity) and improve health. In addition, the modern workplace fosters&#xD;
      sedentary behavior, and sedentary jobs now make up more than 80% of the workforce. The goal&#xD;
      of this project is to implement interventions to reduce sedentary behavior at work and&#xD;
      evaluate their impact on physiologic parameters and markers of disease. Specifically, the&#xD;
      investigators/study team will use direct measurement of vascular endothelial function as one&#xD;
      of our outcomes. This is important since conduit artery endothelial function, assessed by&#xD;
      arterial flow-mediated dilation (FMD), is a powerful indicator of vascular inflammation and&#xD;
      predictor of future cardiovascular events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis is that obese subjects with sedentary jobs at the Medical College of&#xD;
      Wisconsin, when assigned use of a standing desk to encourage movement, will reduce their&#xD;
      daily sedentary time and demonstrate improvement in physiologic parameters and disease&#xD;
      markers from baseline through the end of the intervention.&#xD;
&#xD;
      Prior intervention studies are limited and not randomized, but have shown a reduction in&#xD;
      waist circumference and improvements in cholesterol when overall sitting time is reduced over&#xD;
      a 3-6 month interval (with a standing or treadmill desk). None of these intervention studies&#xD;
      have directly measured vascular endothelial function, as assessed by arterial flow-mediated&#xD;
      dilation (FMD), an early indicator of cardiovascular disease, and a powerful predictor of&#xD;
      future cardiovascular events and vascular inflammation. Improvements in arterial FMD (or&#xD;
      endothelial function) are known to reduce the future risk of cardiovascular events.&#xD;
&#xD;
      Due to differences in the energy requirement of lying down, sitting, and standing, there has&#xD;
      been increased research interest in activity type classification based on posture. In the&#xD;
      science of sedentary behaviors, this is an important distinction to consider when evaluating&#xD;
      health outcomes, such as in the present study. Accelerometers (physical activity monitors)&#xD;
      utilize piezoelectric crystal sensor technology to provide a measure of accelerations of the&#xD;
      body during movement and have the advantage of capturing frequency, duration, and intensity&#xD;
      of physical movement minute by minute. Accelerometer technology will be used to analyze the&#xD;
      primary outcome of interest (sedentary time). The study team will collect information on&#xD;
      standing time, sedentary bouts, daily steps, cadence (walking speed in steps/minute), and&#xD;
      exercise activity. The study team will employ a compact and re-usable physical activity&#xD;
      monitor that adheres to the subject's thigh. This will provide objective assessments of&#xD;
      activity levels at baseline and during the intervention. This data can be translated into&#xD;
      energy expenditure or activity intensity categories (METs) and even position (sitting verses&#xD;
      standing). The monitor output is Excel-compatible and is ideal for comparing each subject's&#xD;
      activity and physiological parameters from baseline to intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2016</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The feasibility of implementing workplace interventions to reduce sedentary time, specifically using a sit-stand desk. We will survey the subjects regarding the feasibility and likability of the sit-stand workstation</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Ten Questions using a Likert Scale. Each question has the same 5 options: strongly agree, agree, neutral, disagree, strongly disagree.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The feasibility of implementing workplace interventions to reduce sedentary time, specifically using a sit-stand desk. We will survey the subjects regarding the feasibility and likability of the sit-stand workstation</measure>
    <time_frame>Change from baseline sedentary behaviors after 6 months</time_frame>
    <description>Objectively quantify sitting, standing and walking times (sedentary vs. non-sedentary) using an accelerometer device that adheres to the subjects thigh</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Impact of reducing sedentary time on physiological outcomes</measure>
    <time_frame>Change from baseline after use of a standing desk, through study completion, an average of 6 months</time_frame>
    <description>Measure Flow Mediated Dilation (FMD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Impact of reducing sedentary time on physiological outcomes</measure>
    <time_frame>Change from baseline after use of a standing desk, through study completion, an average of 6 months</time_frame>
    <description>Measure Near-infrared spectroscopy is a spectroscopic (NIRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Impact of reducing sedentary time on physiological outcomes</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>anthropometrics: Change from baseline body mass index after use of a standing desk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Impact of reducing sedentary time on physiological outcomes</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>measure cardiac hemodynamics: Change from baseline systolic and diastolic blood pressure after use of a standing desk,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Impact of reducing sedentary time on physiological outcomes</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>measure cardiac hemodynamics: Change from heart rate after use of a standing desk,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Impact of reducing sedentary time on physiological outcomes</measure>
    <time_frame>At baseline after use of a standing desk, through study completion, an average of 6 months</time_frame>
    <description>Measure blood lab results: Change from baseline fasting lipids, insulin resistance, hemoglobin A1c and C-reactive protein (CRP)</description>
  </secondary_outcome>
  <enrollment type="Actual">16</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <condition>Obesity</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood (10 ml) and urine (10cc)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sedentary office workers at the Medical College of Wisconsin who spend greater than 75% of&#xD;
        their (8 hours or longer) work-day sitting at a desk.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary office workers the Medical College of Wisconsin who spend greater than 75%&#xD;
             of their (8 hours or longer) work-day sitting at a desk. This includes at least 1&#xD;
             period of 2 hours or longer of uninterrupted sitting time per work day.&#xD;
&#xD;
          -  Body mass index of 26.0-44.9&#xD;
&#xD;
          -  Willing and able to sign Informed consent&#xD;
&#xD;
          -  Permission from the subject's supervisor to participate in the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of atherosclerotic cardiovascular disease, including myocardial&#xD;
             infarction, stroke, coronary stent, coronary artery bypass grafting, angina and&#xD;
             peripheral vascular disease&#xD;
&#xD;
          -  Diabetics on insulin or other diabetic medications (pre-diabetes would be acceptable,&#xD;
             defined as a HbgA1c of 5.7 to 6.4%, and not on medications)&#xD;
&#xD;
          -  Elevated blood pressure (SBP≥150 mm Hg or DBP ≥90 mm Hg) or on medication for&#xD;
             hypertension; or SBP &lt; 100 mm Hg.&#xD;
&#xD;
          -  On cholesterol-lowering medication or LDL-C cholesterol ≥190 mg/dL&#xD;
&#xD;
          -  Pregnancy, lactating or planning to get pregnant within the next 6 months&#xD;
&#xD;
          -  Current tobacco use within previous 12 months. Tobacco use included cigarettes,&#xD;
             cigars, and all forms of smokeless tobacco.&#xD;
&#xD;
          -  Current excessive alcohol use (defined as more than 14 drinks/week for women, more&#xD;
             than 28 drinks/week for men)&#xD;
&#xD;
          -  Current illicit drug use, defined as overuse of prescription medications, or of any&#xD;
             illegal mind altering substances.&#xD;
&#xD;
          -  Known thyroid disease&#xD;
&#xD;
          -  Taking diet pills, or supplements other than those contained in a multi-vitamin&#xD;
&#xD;
          -  History of musculoskeletal surgery/injury that would interfere with prolonged periods&#xD;
             of standing&#xD;
&#xD;
          -  History of use of PDE-5 inhibitors for any reason within the last 5 days of screening&#xD;
             visit, and the inability to hold use of PDE-5 inhibitors for 5 days prior to each of&#xD;
             the FMD evaluations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>September 24, 2021</last_update_submitted>
  <last_update_submitted_qc>September 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Jacquelyn Kulinski</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816150
org study id: 25912
nct id: NCT03816150
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prior research suggests that sedentary behavior is detrimental to health, independent of
      exercise activity. Sedentary behavior is defined as behaviors that involve low levels of
      energy expenditure ≤1.5 metabolic equivalents (including sitting, watching TV, reading, and
      driving). Due to the high burden of sedentary behaviors in modern-day societies, this has
      potential implications for novel intervention strategies to reduce sitting (outside of
      regular exercise activity) and improve health. In addition, the modern workplace fosters
      sedentary behavior, and sedentary jobs now make up more than 80% of the workforce. The goal
      of this project is to implement interventions to reduce sedentary behavior at work and
      evaluate their impact on physiologic parameters and markers of disease. Specifically, the
      investigators/study team will use direct measurement of vascular endothelial function as one
      of our outcomes. This is important since conduit artery endothelial function, assessed by
      arterial flow-mediated dilation (FMD), is a powerful indicator of vascular inflammation and
      predictor of future cardiovascular events.
The hypothesis is that obese subjects with sedentary jobs at the Medical College of
      Wisconsin, when assigned use of a standing desk to encourage movement, will reduce their
      daily sedentary time and demonstrate improvement in physiologic parameters and disease
      markers from baseline through the end of the intervention.

      Prior intervention studies are limited and not randomized, but have shown a reduction in
      waist circumference and improvements in cholesterol when overall sitting time is reduced over
      a 3-6 month interval (with a standing or treadmill desk). None of these intervention studies
      have directly measured vascular endothelial function, as assessed by arterial flow-mediated
      dilation (FMD), an early indicator of cardiovascular disease, and a powerful predictor of
      future cardiovascular events and vascular inflammation. Improvements in arterial FMD (or
      endothelial function) are known to reduce the future risk of cardiovascular events.

      Due to differences in the energy requirement of lying down, sitting, and standing, there has
      been increased research interest in activity type classification based on posture. In the
      science of sedentary behaviors, this is an important distinction to consider when evaluating
      health outcomes, such as in the present study. Accelerometers (physical activity monitors)
      utilize piezoelectric crystal sensor technology to provide a measure of accelerations of the
      body during movement and have the advantage of capturing frequency, duration, and intensity
      of physical movement minute by minute. Accelerometer technology will be used to analyze the
      primary outcome of interest (sedentary time). The study team will collect information on
      standing time, sedentary bouts, daily steps, cadence (walking speed in steps/minute), and
      exercise activity. The study team will employ a compact and re-usable physical activity
      monitor that adheres to the subject's thigh. This will provide objective assessments of
      activity levels at baseline and during the intervention. This data can be translated into
      energy expenditure or activity intensity categories (METs) and even position (sitting verses
      standing). The monitor output is Excel-compatible and is ideal for comparing each subject's
      activity and physiological parameters from baseline to intervention.
observational model: Case-Only
time perspective: Prospective
measure: The feasibility of implementing workplace interventions to reduce sedentary time, specifically using a sit-stand desk. We will survey the subjects regarding the feasibility and likability of the sit-stand workstation
time frame: through study completion, an average of 6 months
description: Ten Questions using a Likert Scale. Each question has the same 5 options: strongly agree, agree, neutral, disagree, strongly disagree.
measure: The feasibility of implementing workplace interventions to reduce sedentary time, specifically using a sit-stand desk. We will survey the subjects regarding the feasibility and likability of the sit-stand workstation
time frame: Change from baseline sedentary behaviors after 6 months
description: Objectively quantify sitting, standing and walking times (sedentary vs. non-sedentary) using an accelerometer device that adheres to the subjects thigh
measure: The Impact of reducing sedentary time on physiological outcomes
time frame: Change from baseline after use of a standing desk, through study completion, an average of 6 months
description: Measure Flow Mediated Dilation (FMD)
measure: The Impact of reducing sedentary time on physiological outcomes
time frame: Change from baseline after use of a standing desk, through study completion, an average of 6 months
description: Measure Near-infrared spectroscopy is a spectroscopic (NIRS)
measure: The Impact of reducing sedentary time on physiological outcomes
time frame: Through study completion, an average of 6 months
description: anthropometrics: Change from baseline body mass index after use of a standing desk
measure: The Impact of reducing sedentary time on physiological outcomes
time frame: Through study completion, an average of 6 months
description: measure cardiac hemodynamics: Change from baseline systolic and diastolic blood pressure after use of a standing desk,
measure: The Impact of reducing sedentary time on physiological outcomes
time frame: Through study completion, an average of 6 months
description: measure cardiac hemodynamics: Change from heart rate after use of a standing desk,
measure: The Impact of reducing sedentary time on physiological outcomes
time frame: At baseline after use of a standing desk, through study completion, an average of 6 months
description: Measure blood lab results: Change from baseline fasting lipids, insulin resistance, hemoglobin A1c and C-reactive protein (CRP)
blood (10 ml) and urine (10cc)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Jacquelyn Kulinski
investigator title: Associate Professor