<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/NCT03307343</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19030297</org_study_id>
    <secondary_id>R01HL134809</secondary_id>
    <nct_id>NCT03307343</nct_id>
  </id_info>
  <brief_title>Effect of Reducing Sedentary Behavior on Blood Pressure</brief_title>
  <acronym>RESET-BP</acronym>
  <official_title>Effect of Reducing Sedentary Behavior on Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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 is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention&#xD;
      vs. control in working adults (n=300). The primary outcome is resting systolic blood pressure&#xD;
      (SBP) at 3 months; secondary outcomes will be resting diastolic blood pressure (DBP),&#xD;
      ambulatory blood pressure (ABP), and carotid-femoral pulse wave velocity (cfPWV). Also, best&#xD;
      practice objective activity monitoring will be leveraged in the analysis of ABP to account&#xD;
      for recent activity and posture and will inform adherence and dose-response relationships.We&#xD;
      will also measure plasma renin activity and aldosterone as a potential mechanism of blood&#xD;
      pressure reduction, and insulin and glucose as exploratory outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension (HTN) is the most common major risk factor for cardiovascular disease (CVD),&#xD;
      affecting 1 in 3 American adults. Also, nearly another 1 in 3 adults has prehypertension&#xD;
      (preHTN). Moderate-to-vigorous intensity physical activity (MVPA) is known to decrease BP.&#xD;
      Guidelines recommend 150 min/week of MVPA performed in continuous bouts of ≥10 min (i.e.,&#xD;
      bouted MVPA). Sedentary behavior (SED), defined as sitting or reclining with low energy&#xD;
      expenditure, has gained attention as a highly prevalent and distinct behavior from MVPA that&#xD;
      is independently associated with higher BP, arterial stiffness, CVD, and mortality. These&#xD;
      data, coupled with the fact that Americans spend more than half of the waking day in SED,&#xD;
      suggest SED as a novel intervention target. Yet, despite heightened public perception of SED&#xD;
      as a health risk, there is a dearth of randomized clinical trials demonstrating that SED&#xD;
      reduction will lead to health benefits, including reduced BP. Decreasing SED more&#xD;
      substantially could improve BP, but this remains unclear in the absence of larger randomized&#xD;
      trials with effective SED interventions.&#xD;
&#xD;
      Thus, to test initial efficacy, the Effect of Reducing Sedentary Behavior on Blood Pressure&#xD;
      (RESET-BP) has the following specific aims:&#xD;
&#xD;
      Specific aim 1: To evaluate the efficacy of our intervention targeting decreased sedentary&#xD;
      behavior (SED) over 3 months. Outcomes include SBP (primary), DBP, ABP (nocturnal, daytime&#xD;
      seated, daytime non-seated), and cfPWV. We hypothesize that the 3-month SED intervention will&#xD;
      decrease SBP, DBP, ABP and cfPWV vs. controls&#xD;
&#xD;
      Specific Aim 2: To explore whether renin-angiotensin-aldosterone (RAAS) activation (increased&#xD;
      plasma renin activity (PRA) and aldosterone) mediates changes in BP elicited by SED reduction&#xD;
&#xD;
      Specific Aim 3: To examine associations between achieved reductions in SED, increases in&#xD;
      replacement behaviors (i.e., standing, other light-intensity physical activity (LPA), and BP&#xD;
      reduction&#xD;
&#xD;
      These aims will be evaluated with a 2-arm, 3-month randomized trial comparing a novel SED&#xD;
      intervention vs. control in 300 adults (150 per group). The study will recruit adults with&#xD;
      untreated, elevated blood pressure (SBP 120-159 mmHg or DBP 80-99 mmHg) and desk jobs that&#xD;
      require prolonged SED to maximize the opportunity for SED reduction. The intervention will&#xD;
      target currently recommended levels of SED reduction for desk-based employees (2-4 hours/day&#xD;
      with frequent postural changes) and will use a behavioral intervention including individual&#xD;
      in-person (1/month) and phone counselling (1/month) focused on goal setting, overcoming&#xD;
      barriers, self-monitoring, social support, and stimulus control. In addition, the&#xD;
      intervention will include environmental modification via provision of a sit-stand desk&#xD;
      attachment and external prompting via text messaging and a wrist-worn inactivity prompter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</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>
    <masking_description>Outcome assessors will be blinded to the participant group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Resting Systolic Blood Pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24-hour Ambulatory Blood Pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Ambulatory blood pressure will be measured at baseline and 3-month follow-up during a workday and overnight (24 hours total) at the beginning and end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Wave Velocity</measure>
    <time_frame>3 months</time_frame>
    <description>Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Renin Activity</measure>
    <time_frame>3 months</time_frame>
    <description>PRA will be measured at baseline and 3-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aldosterone</measure>
    <time_frame>3 months</time_frame>
    <description>Aldosterone will be measured at baseline and 3-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>3 months</time_frame>
    <description>Weight will be measured by digital scale at baseline and follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose</measure>
    <time_frame>3 months</time_frame>
    <description>Glucose will be measured at baseline and follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin</measure>
    <time_frame>3 months</time_frame>
    <description>Insulin will be measured at baseline and follow-up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Adverse events will be measured in an ongoing fashion (as reported) and formally at the 3-month outcome assessment by blinded personnel in all participants.</time_frame>
    <description>We will compare adverse events between groups in the following two ways: 1) all reported events and 2) events reported at the 3-month outcome assessment. Because the increased contact with intervention participants (vs. no-contact control) could provide greater opportunity to report adverse events occurring over the 3-month study period, these two comparisons will help clarify associations between the intervention and adverse events.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Hypertension</condition>
  <condition>Prehypertension</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Sedentary Behavior Reduction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21-65 years&#xD;
&#xD;
          2. SBP 120-159 mmHg or DBP of 80-99&#xD;
&#xD;
          3. Inactive (Engages in less than 150 min/wk of moderate + 2 x vigorous intensity&#xD;
             physical activity)&#xD;
&#xD;
          4. Currently perform deskwork for ≥ 20 hr/week at a desk compatible with the sit-stand&#xD;
             attachment&#xD;
&#xD;
          5. Employment within an approximate 25-mile radius of the University of Pittsburgh&#xD;
&#xD;
          6. Stable employment (≥ 3 months in current job, plan to be in current job for the next 3&#xD;
             months)&#xD;
&#xD;
          7. Supervisor approval to join the intervention&#xD;
&#xD;
          8. Possession of a cellular phone able to receive text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. SBP ≥ 160 mmHg, DBP ≥ 100 mmHg&#xD;
&#xD;
          2. Use of antihypertensive or glucose controlling medication&#xD;
&#xD;
          3. Comorbid condition that would limit ability to reduce sedentary behavior (e.g.&#xD;
             musculoskeletal condition, current chemotherapy)&#xD;
&#xD;
          4. History of ischemic heart disease, chronic heart failure, stroke, or chronic kidney&#xD;
             disease&#xD;
&#xD;
          5. Unable to obtain consent from primary care provider or physician to participate&#xD;
&#xD;
          6. Current use of sit-stand/standing desk, sedentary behavior prompting device,&#xD;
             enrollment in a weight loss or exercise study or program, recent (&lt; 1 year) or planned&#xD;
             bariatric surgery&#xD;
&#xD;
          7. Currently pregnant or pregnant in that last 6 months; breastfeeding currently or in&#xD;
             the last 3 months&#xD;
&#xD;
          8. Plans to be away from your desk for an extended period (&gt;1 week) during the study&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bethany Barone Gibbs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Physical Activity and Weight Management Research Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Bethany Barone Gibbs</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sedentary behavior</keyword>
  <keyword>light intensity physical activity</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>office workers</keyword>
  <keyword>blood pressure</keyword>
  <keyword>pulse wave velocity</keyword>
  <keyword>randomized clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prehypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Immediately following publication with no planned end date.</ipd_time_frame>
    <ipd_access_criteria>Data access will be provided to researchers who provide a methodologically sound proposal.</ipd_access_criteria>
  </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/NCT03307343
org study id: STUDY19030297
secondary id: R01HL134809
nct id: NCT03307343
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a 2-arm, 3-month randomized trial comparing a novel sedentary behavior intervention
      vs. control in working adults (n=300). The primary outcome is resting systolic blood pressure
      (SBP) at 3 months; secondary outcomes will be resting diastolic blood pressure (DBP),
      ambulatory blood pressure (ABP), and carotid-femoral pulse wave velocity (cfPWV). Also, best
      practice objective activity monitoring will be leveraged in the analysis of ABP to account
      for recent activity and posture and will inform adherence and dose-response relationships.We
      will also measure plasma renin activity and aldosterone as a potential mechanism of blood
      pressure reduction, and insulin and glucose as exploratory outcomes.
Hypertension (HTN) is the most common major risk factor for cardiovascular disease (CVD),
      affecting 1 in 3 American adults. Also, nearly another 1 in 3 adults has prehypertension
      (preHTN). Moderate-to-vigorous intensity physical activity (MVPA) is known to decrease BP.
      Guidelines recommend 150 min/week of MVPA performed in continuous bouts of ≥10 min (i.e.,
      bouted MVPA). Sedentary behavior (SED), defined as sitting or reclining with low energy
      expenditure, has gained attention as a highly prevalent and distinct behavior from MVPA that
      is independently associated with higher BP, arterial stiffness, CVD, and mortality. These
      data, coupled with the fact that Americans spend more than half of the waking day in SED,
      suggest SED as a novel intervention target. Yet, despite heightened public perception of SED
      as a health risk, there is a dearth of randomized clinical trials demonstrating that SED
      reduction will lead to health benefits, including reduced BP. Decreasing SED more
      substantially could improve BP, but this remains unclear in the absence of larger randomized
      trials with effective SED interventions.

      Thus, to test initial efficacy, the Effect of Reducing Sedentary Behavior on Blood Pressure
      (RESET-BP) has the following specific aims:

      Specific aim 1: To evaluate the efficacy of our intervention targeting decreased sedentary
      behavior (SED) over 3 months. Outcomes include SBP (primary), DBP, ABP (nocturnal, daytime
      seated, daytime non-seated), and cfPWV. We hypothesize that the 3-month SED intervention will
      decrease SBP, DBP, ABP and cfPWV vs. controls

      Specific Aim 2: To explore whether renin-angiotensin-aldosterone (RAAS) activation (increased
      plasma renin activity (PRA) and aldosterone) mediates changes in BP elicited by SED reduction

      Specific Aim 3: To examine associations between achieved reductions in SED, increases in
      replacement behaviors (i.e., standing, other light-intensity physical activity (LPA), and BP
      reduction

      These aims will be evaluated with a 2-arm, 3-month randomized trial comparing a novel SED
      intervention vs. control in 300 adults (150 per group). The study will recruit adults with
      untreated, elevated blood pressure (SBP 120-159 mmHg or DBP 80-99 mmHg) and desk jobs that
      require prolonged SED to maximize the opportunity for SED reduction. The intervention will
      target currently recommended levels of SED reduction for desk-based employees (2-4 hours/day
      with frequent postural changes) and will use a behavioral intervention including individual
      in-person (1/month) and phone counselling (1/month) focused on goal setting, overcoming
      barriers, self-monitoring, social support, and stimulus control. In addition, the
      intervention will include environmental modification via provision of a sit-stand desk
      attachment and external prompting via text messaging and a wrist-worn inactivity prompter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessors will be blinded to the participant group assignment.
measure: Resting Systolic Blood Pressure
time frame: 3 months
description: Resting systolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions
measure: 24-hour Ambulatory Blood Pressure
time frame: 3 months
description: Ambulatory blood pressure will be measured at baseline and 3-month follow-up during a workday and overnight (24 hours total) at the beginning and end of the study.
measure: Pulse Wave Velocity
time frame: 3 months
description: Carotid-femoral and carotid-radial pulse wave velocity will be measured at baseline and follow-up following a 10-min supine rest via tonometry.
measure: Plasma Renin Activity
time frame: 3 months
description: PRA will be measured at baseline and 3-month follow-up.
measure: Aldosterone
time frame: 3 months
description: Aldosterone will be measured at baseline and 3-month follow-up.
measure: Diastolic Blood Pressure
time frame: 3 months
description: Resting diastolic blood pressure will be measured at baseline and follow-up using an oscillometric device after a 10-min rest on two occasions
measure: Weight
time frame: 3 months
description: Weight will be measured by digital scale at baseline and follow-up.
measure: Glucose
time frame: 3 months
description: Glucose will be measured at baseline and follow-up.
measure: Insulin
time frame: 3 months
description: Insulin will be measured at baseline and follow-up.
measure: Adverse Events
time frame: Adverse events will be measured in an ongoing fashion (as reported) and formally at the 3-month outcome assessment by blinded personnel in all participants.
description: We will compare adverse events between groups in the following two ways: 1) all reported events and 2) events reported at the 3-month outcome assessment. Because the increased contact with intervention participants (vs. no-contact control) could provide greater opportunity to report adverse events occurring over the 3-month study period, these two comparisons will help clarify associations between the intervention and adverse events.
arm group label: Intervention
arm group type: Experimental
description: The intervention will use behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts to target a 2-4 hour/day reduction in sedentary behavior.
arm group label: Control
arm group type: No Intervention
description: Participants randomized to the control condition will receive no intervention during the study. After the 3-month assessment, control participants will be provided with a wrist-worn activity monitor and will be offered the 3-month delayed intervention if desired to aid in retention and recruitment.
intervention type: Behavioral
intervention name: Intervention
description: The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.
arm group label: Intervention
other name: Sedentary Behavior Reduction
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bethany Barone Gibbs, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Bethany Barone Gibbs
investigator title: Assistant Professor
mesh term: Prehypertension
sharing ipd: Yes
ipd description: All of the deidentified individual participant data collected during the trial will be shared (including the data dictionary).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Immediately following publication with no planned end date.
ipd access criteria: Data access will be provided to researchers who provide a methodologically sound proposal.