<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/NCT02970123</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00093477</org_study_id>
    <secondary_id>1R21DK106574-01A1</secondary_id>
    <nct_id>NCT02970123</nct_id>
  </id_info>
  <brief_title>Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)</brief_title>
  <acronym>SLIMM</acronym>
  <official_title>Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Srinvasan Beddhu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sedentary behavior is engaging in activities in the seated or lying position that barely&#xD;
      raise the energy expenditure level and has emerged as an important risk factor for obesity,&#xD;
      diabetes, cardiovascular disease and mortality.&#xD;
&#xD;
      The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in&#xD;
      Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing&#xD;
      casual walking duration and thereby, increase physical activity energy expenditure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are an estimated 15.5 million adults with stage 3 chronic kidney disease (CKD) while&#xD;
      only about 600,000 patients have end-stage renal disease (ESRD) in the United States. This is&#xD;
      because most of the people with CKD die before they reach ESRD. In order to decrease the high&#xD;
      mortality in the CKD population, the &quot;non-renal&quot; issues that contribute to increased&#xD;
      morbidity and mortality in this population need to be addressed.&#xD;
&#xD;
      Relevance of sedentary behavior in CKD: Prolonged sitting time (as assessed by a&#xD;
      questionnaire or television viewing time) was associated with lower kidney function. Total&#xD;
      and light physical activities, measured objectively with an accelerometer were found to be&#xD;
      positively associated with kidney function in a study of community dwelling adults. In an&#xD;
      analysis of National Health and Nutrition Examination Survey (NHANES) data, it was noted that&#xD;
      participants with CKD spent more than two-thirds of the awake time in sedentary activities&#xD;
      and longer sedentary duration was associated with increased mortality. It was also noted in&#xD;
      another study that compared to those with CKD, those on maintenance hemodialysis had 3.4 fold&#xD;
      higher odds of being sedentary independent of demographics, co-morbidity, body size, serum&#xD;
      C-Reactive Protein (CRP) and albumin. Thus, sedentary behavior is very common in CKD, appears&#xD;
      to worsen with more advanced kidney failure and increases mortality risk in this population.&#xD;
&#xD;
      Feasibility of replacing sedentary activities with moderate/ vigorous physical activities:&#xD;
      Moderate/ vigorous physical activities are less likely to be an effective replacement for&#xD;
      sedentary activities as most Americans do not reach even the current goals and achieving the&#xD;
      currently recommended levels of 2.5 hrs/ week of moderate/ vigorous activities would account&#xD;
      only for 2% of the total awake time (112 hours/week). Therefore, decreasing sedentary&#xD;
      activities must involve an increase in activities that are less intensive than moderate/&#xD;
      vigorous activities.&#xD;
&#xD;
      The concept of Non- Exercise Activity Thermogenesis (NEAT) and biological relevance of light&#xD;
      intensity activity: In a overfeeding study, it was demonstrated that increase (average 336&#xD;
      kcal/day) in non- exercise activity thermogenesis accounted for 10-fold differences in fat&#xD;
      storage, directly predicted resistance to fat gain and explained most of the variations in&#xD;
      weight gain between participants. Obese persons have less non-exercise activity thermogenesis&#xD;
      and spend an average of 2 hrs/d more in a seated position compared to lean persons.&#xD;
      Objectively measured light activity was inversely associated with insulin resistance and&#xD;
      cardiometabolic risk factors. Daily lifestyle activities were negatively associated with&#xD;
      insulin resistance. Thus, replacing sedentary activities with non-exercise intensity&#xD;
      activities of daily living could increase energy expenditure and decrease adiposity.&#xD;
&#xD;
      Determining what kind of light activity would be most beneficial in replacing sedentary&#xD;
      activity: As standing (~ 1.5 Metabolic Equivalents of Task (METs)) is by definition&#xD;
      non-sedentary (i.e. not sitting or lying down), one might consider replacing sitting duration&#xD;
      with standing duration in order to decrease sedentary behavior. However, replacing sitting&#xD;
      duration with casual walking (2 to 2.9 METs) duration might be even more beneficial. This&#xD;
      notion is supported by the following theoretical calculations of energy expenditure. Assuming&#xD;
      16 hrs/day of awake time, it was calculated that the weekly energy expenditure for a person&#xD;
      weighing 80 kg for trade-off of 1 to 5 min/hr of sedentary activity at 1.2 METs with 1.5 METs&#xD;
      (standing intensity activities) or 2.5 METs (casual walking intensity activities). Additional&#xD;
      kcal/week was calculated as the difference in energy expenditure between sedentary activity&#xD;
      and 1.5 or 2.5 METs activity using the equation Kcal/ week = (METs/hr) x weight in kg X&#xD;
      weekly duration of the physical activity. Trade-off of 1-5 min/hr of sedentary duration with&#xD;
      standing intensity activities duration is expected to result in additional weekly expenditure&#xD;
      of 50-250 Kcal only. On the other hand, similar trade off of sedentary duration with casual&#xD;
      walking intensity activities duration is expected to result in ~ 200 to 1000 Kcal/ week of&#xD;
      additional energy expenditure. This is consistent with prior observation that increase in&#xD;
      non-exercise activities could lead to an additional 350 Kcal/d of energy expenditure in obese&#xD;
      individuals.&#xD;
&#xD;
      Indeed, in the NHANES analyses, it was noted that trade-off sedentary duration for light&#xD;
      intensity (2.0 to 2.9 METs) activities but not for very light intensity (1.5 to 1.9 METs)&#xD;
      duration was associated with significantly lower risk of mortality. Thus, replacing sedentary&#xD;
      duration with casual walking duration could increase energy expenditure and decrease&#xD;
      mortality in CKD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">September 12, 2019</completion_date>
  <primary_completion_date type="Actual">September 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sedentary Activity Duration</measure>
    <time_frame>Baseline and 24 Weeks</time_frame>
    <description>Change in sedentary activity duration (average sedentary minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Casual Walking Duration</measure>
    <time_frame>Baseline and 24 Weeks</time_frame>
    <description>Change in casual walking activity duration (average walking minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>Baseline and 24 Weeks</time_frame>
    <description>Change in waist circumference, measured in centimeters, from baseline to 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Non-Exercise Activity Thermogenesis</measure>
    <time_frame>Baseline and 24 Weeks</time_frame>
    <description>Change in non-exercise activity thermogenesis, measured in kilocalorie/kilogram/hour, from baseline to 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Function</measure>
    <time_frame>Baseline and 24 Weeks</time_frame>
    <description>Change in walking distance, measured in meters, using the 6-minute walk test from baseline to 24 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>SLIMM Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sit Less, Interact, Move More (SLIMM): instruction and monitoring feedback to promote decrease in sedentary activity duration, increase in casual walking duration, and increase in sedentary breaks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive standard of care treatment for chronic kidney disease, with no instruction or feedback to alter sedentary or casual walking durations</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sit Less, Interact, Move More (SLIMM)</intervention_name>
    <arm_group_label>SLIMM Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 3/4 Chronic Kidney Disease, as defined by estimated glomerular filtration rate&#xD;
             (eGFR) 15 to &lt; 60 ml/min/1.73m^2&#xD;
&#xD;
          -  Body Mass Index (BMI): 25 to 39.9 kg/m^2&#xD;
&#xD;
          -  Able to achieve gait speed of &gt; 1 m/sec and able to walk ≥ 320 meters in the 6-minute&#xD;
             walk test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous renal replacement therapy&#xD;
&#xD;
          -  Life expectancy &lt; 1 year&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prison incarceration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Srinivasan Beddhu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://well.blogs.nytimes.com/2015/05/13/a-2-minute-walk-may-counter-the-harms-of-sitting/?_r=0</url>
    <description>A 2-Minute Walk May Counter the Harms of Sitting: By Gretchen Reynolds</description>
  </link>
  <link>
    <url>http://www.npr.org/sections/health-shots/2015/05/01/403523463/two-minutes-of-walking-anhour-boosts-health-but-its-no-panacea</url>
    <description>. Walking 2 Minutes An Hour Boosts Health, But It's No Panacea. By Patti Neighmond</description>
  </link>
  <link>
    <url>https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213745/dh_128225.pdf</url>
    <description>The Department of Health. The Sedentary Behaviour and Obesity Expert Working Group: Sedentary Behaviour and Obesity: Review of the Current Scientific Evidence</description>
  </link>
  <link>
    <url>http://wwwn.cdc.gov/nchs/nhanes/search/nhanes03_04.aspx</url>
    <description>Centers for Disease Control and Prevenion. National Center for Health Statistics -NHANES 2003-2004</description>
  </link>
  <link>
    <url>http://www.usrds.org/2012/pdf/v2_00intro_12.pdf</url>
    <description>USRDS Annual Data Report Atlas of End-Stage Renal Disease in the United States.</description>
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  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Srinvasan Beddhu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02970123
org study id: IRB_00093477
secondary id: 1R21DK106574-01A1
nct id: NCT02970123
lead sponsor: 
collaborator: 
has dmc: No
Sedentary behavior is engaging in activities in the seated or lying position that barely
      raise the energy expenditure level and has emerged as an important risk factor for obesity,
      diabetes, cardiovascular disease and mortality.

      The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in
      Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing
      casual walking duration and thereby, increase physical activity energy expenditure.
There are an estimated 15.5 million adults with stage 3 chronic kidney disease (CKD) while
      only about 600,000 patients have end-stage renal disease (ESRD) in the United States. This is
      because most of the people with CKD die before they reach ESRD. In order to decrease the high
      mortality in the CKD population, the "non-renal" issues that contribute to increased
      morbidity and mortality in this population need to be addressed.

      Relevance of sedentary behavior in CKD: Prolonged sitting time (as assessed by a
      questionnaire or television viewing time) was associated with lower kidney function. Total
      and light physical activities, measured objectively with an accelerometer were found to be
      positively associated with kidney function in a study of community dwelling adults. In an
      analysis of National Health and Nutrition Examination Survey (NHANES) data, it was noted that
      participants with CKD spent more than two-thirds of the awake time in sedentary activities
      and longer sedentary duration was associated with increased mortality. It was also noted in
      another study that compared to those with CKD, those on maintenance hemodialysis had 3.4 fold
      higher odds of being sedentary independent of demographics, co-morbidity, body size, serum
      C-Reactive Protein (CRP) and albumin. Thus, sedentary behavior is very common in CKD, appears
      to worsen with more advanced kidney failure and increases mortality risk in this population.

      Feasibility of replacing sedentary activities with moderate/ vigorous physical activities:
      Moderate/ vigorous physical activities are less likely to be an effective replacement for
      sedentary activities as most Americans do not reach even the current goals and achieving the
      currently recommended levels of 2.5 hrs/ week of moderate/ vigorous activities would account
      only for 2% of the total awake time (112 hours/week). Therefore, decreasing sedentary
      activities must involve an increase in activities that are less intensive than moderate/
      vigorous activities.

      The concept of Non- Exercise Activity Thermogenesis (NEAT) and biological relevance of light
      intensity activity: In a overfeeding study, it was demonstrated that increase (average 336
      kcal/day) in non- exercise activity thermogenesis accounted for 10-fold differences in fat
      storage, directly predicted resistance to fat gain and explained most of the variations in
      weight gain between participants. Obese persons have less non-exercise activity thermogenesis
      and spend an average of 2 hrs/d more in a seated position compared to lean persons.
      Objectively measured light activity was inversely associated with insulin resistance and
      cardiometabolic risk factors. Daily lifestyle activities were negatively associated with
      insulin resistance. Thus, replacing sedentary activities with non-exercise intensity
      activities of daily living could increase energy expenditure and decrease adiposity.

      Determining what kind of light activity would be most beneficial in replacing sedentary
      activity: As standing (~ 1.5 Metabolic Equivalents of Task (METs)) is by definition
      non-sedentary (i.e. not sitting or lying down), one might consider replacing sitting duration
      with standing duration in order to decrease sedentary behavior. However, replacing sitting
      duration with casual walking (2 to 2.9 METs) duration might be even more beneficial. This
      notion is supported by the following theoretical calculations of energy expenditure. Assuming
      16 hrs/day of awake time, it was calculated that the weekly energy expenditure for a person
      weighing 80 kg for trade-off of 1 to 5 min/hr of sedentary activity at 1.2 METs with 1.5 METs
      (standing intensity activities) or 2.5 METs (casual walking intensity activities). Additional
      kcal/week was calculated as the difference in energy expenditure between sedentary activity
      and 1.5 or 2.5 METs activity using the equation Kcal/ week = (METs/hr) x weight in kg X
      weekly duration of the physical activity. Trade-off of 1-5 min/hr of sedentary duration with
      standing intensity activities duration is expected to result in additional weekly expenditure
      of 50-250 Kcal only. On the other hand, similar trade off of sedentary duration with casual
      walking intensity activities duration is expected to result in ~ 200 to 1000 Kcal/ week of
      additional energy expenditure. This is consistent with prior observation that increase in
      non-exercise activities could lead to an additional 350 Kcal/d of energy expenditure in obese
      individuals.

      Indeed, in the NHANES analyses, it was noted that trade-off sedentary duration for light
      intensity (2.0 to 2.9 METs) activities but not for very light intensity (1.5 to 1.9 METs)
      duration was associated with significantly lower risk of mortality. Thus, replacing sedentary
      duration with casual walking duration could increase energy expenditure and decrease
      mortality in CKD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Sedentary Activity Duration
time frame: Baseline and 24 Weeks
description: Change in sedentary activity duration (average sedentary minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks
measure: Change in Casual Walking Duration
time frame: Baseline and 24 Weeks
description: Change in casual walking activity duration (average walking minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks
measure: Change in Waist Circumference
time frame: Baseline and 24 Weeks
description: Change in waist circumference, measured in centimeters, from baseline to 24 weeks
measure: Change in Non-Exercise Activity Thermogenesis
time frame: Baseline and 24 Weeks
description: Change in non-exercise activity thermogenesis, measured in kilocalorie/kilogram/hour, from baseline to 24 weeks
measure: Change in Physical Function
time frame: Baseline and 24 Weeks
description: Change in walking distance, measured in meters, using the 6-minute walk test from baseline to 24 weeks
arm group label: SLIMM Intervention
arm group type: Experimental
description: Sit Less, Interact, Move More (SLIMM): instruction and monitoring feedback to promote decrease in sedentary activity duration, increase in casual walking duration, and increase in sedentary breaks
arm group label: Standard of Care
arm group type: No Intervention
description: Subjects will receive standard of care treatment for chronic kidney disease, with no instruction or feedback to alter sedentary or casual walking durations
intervention type: Behavioral
intervention name: Sit Less, Interact, Move More (SLIMM)
arm group label: SLIMM Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Srinivasan Beddhu, M.D.
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
url: http://well.blogs.nytimes.com/2015/05/13/a-2-minute-walk-may-counter-the-harms-of-sitting/?_r=0
description: A 2-Minute Walk May Counter the Harms of Sitting: By Gretchen Reynolds
url: http://www.npr.org/sections/health-shots/2015/05/01/403523463/two-minutes-of-walking-anhour-boosts-health-but-its-no-panacea
description: . Walking 2 Minutes An Hour Boosts Health, But It's No Panacea. By Patti Neighmond
url: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213745/dh_128225.pdf
description: The Department of Health. The Sedentary Behaviour and Obesity Expert Working Group: Sedentary Behaviour and Obesity: Review of the Current Scientific Evidence
url: http://wwwn.cdc.gov/nchs/nhanes/search/nhanes03_04.aspx
description: Centers for Disease Control and Prevenion. National Center for Health Statistics -NHANES 2003-2004
url: http://www.usrds.org/2012/pdf/v2_00intro_12.pdf
description: USRDS Annual Data Report Atlas of End-Stage Renal Disease in the United States.
url: http://le.utah.gov/lrgc/briefings/PopulationBriefing2014.pdf
description: Utah's Population: Growing fast, Concentrating more, Diversifying rapidly. Utah Legislature Briefing Paper
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responsible party type: Sponsor-Investigator
investigator affiliation: University of Utah
investigator full name: Srinvasan Beddhu
investigator title: Principal Investigator
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No