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/NCT06038188</url>
    </required_header>
    <id_info>
      <org_study_id>NL72604.091.20</org_study_id>
      <secondary_id>#2017T051</secondary_id>
      <nct_id>NCT06038188</nct_id>
    </id_info>
    <brief_title>Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease</brief_title>
    <acronym>BOOSTSITLESS</acronym>
    <official_title>Effectiveness of a Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease: a Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Radboud University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Radboud University Medical Center</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>
        The goal of this clinical trial is to learn about the effect of a booster program aiming to&#xD;
        lower daily sitting time (SIT LESS Booster program) compared to usual care in patient with&#xD;
        coronary heart problems. The main question it aims to answer is: What is the effect of the&#xD;
        SIT LESS Booster on sedentary time and physical activity levels in patient with coronary&#xD;
        artery disease who participated in cardiac rehabilitation.&#xD;
  &#xD;
        Participants will be randomized into 2 groups:&#xD;
  &#xD;
          1. Control group who receives usual care;&#xD;
  &#xD;
          2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster&#xD;
             program.&#xD;
  &#xD;
        Objectively measured changes in daily sitting time from pre- to post SIT LESS Booster will be&#xD;
        compared between groups to see if participants in the SIT LESS Booster group are able to&#xD;
        reduce daily sedentary time more compared to participants in the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        High levels of sedentary time (ST) are observed in patients with coronary artery disease&#xD;
        (CAD) and are associated with adverse health outcomes. Behavioural interventions targeting ST&#xD;
        are effective in the short-term, but effects seem to diminish at long-term follow-up.&#xD;
        Short-term (telephonic) booster programs can induce sustainable physical activity behavioural&#xD;
        changes. However, the effects of a booster ST reduction program are unknown. Therefore, we&#xD;
        aim to assess the effect of the SIT LESS Booster on sedentary time and physical activity&#xD;
        levels in patient with coronary artery disease who participated in cardiac rehabilitation.&#xD;
  &#xD;
        All participants took already part in a special cardiac rehabilitation program aiming to&#xD;
        lower daily sitting time between May 2021 and April 2022. For this study, they will be&#xD;
        randomized into 2 groups:&#xD;
  &#xD;
          1. Control group who receives usual care;&#xD;
  &#xD;
          2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster&#xD;
             program.&#xD;
  &#xD;
        The SIT LESS Booster program consists of:&#xD;
  &#xD;
          -  Telephone consultation in which the participants are informed about the negative effects&#xD;
             of high daily sitting time, discuss personal goals to lower daily sitting time and make&#xD;
             an action plan to reach the goals.&#xD;
  &#xD;
          -  Use of a pocket-worn activity tracker to get insight in their own daily sitting time.&#xD;
             The activity tracker can be connected to a smartphone application. Besides, the activity&#xD;
             tracker buzzes when a person sits more than 30 consecutive minutes as a reminder to&#xD;
             stand up.&#xD;
  &#xD;
          -  Weekly telephone calls to discuss the progress regarding their personal sit less goals.&#xD;
  &#xD;
        In both groups, daily sitting time will be measured at the start of the study and at the end&#xD;
        of the SIT LESS Booster program using the ActivPAL.&#xD;
  &#xD;
        Data analysis will be conducted using R and p-values of &lt;0.05 will be considered&#xD;
        statistically significant. Changes in daily ST will be compared between groups using a linear&#xD;
        mixed model.&#xD;
  &#xD;
        This trial was approved by the Medical Ethics Committee of the Radboud university medical&#xD;
        center (NL72604.091.20)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Daily Sedentary time (h/day)</measure>
      <time_frame>Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program</time_frame>
      <description>Daily sedentary time as measured with the ActivPAL during 7 days</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of prolonged sedentary bouts per day</measure>
      <time_frame>Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program</time_frame>
      <description>Daily number of prolonged sedentary bouts (&gt;30 min/day) as measured with the ActivPAL during 7 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of a sitting time &gt;9.5 h/day</measure>
      <time_frame>Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program</time_frame>
      <description>Prevalence of an average sitting time &gt;9.5 h/day measured by the ActivPAL for 7 consective days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>daily light-intensity physical activity time (h/day)</measure>
      <time_frame>Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program</time_frame>
      <description>Daily time spent in light-intensity physical activity (&lt;3 METs) measured by the ActivPAL for 7 consective days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>daily moderate-to-vigorous-intensity physical activity time (h/day)</measure>
      <time_frame>Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program</time_frame>
      <description>Daily time spent in moderate to vigorous intensity physical activity (&gt;3 METs) measured by the ActivPAL for 7 consective days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>daily step count (steps/day)</measure>
      <time_frame>Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program</time_frame>
      <description>daily step count measured by the ActivPAL for 7 consective days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Uptake of the SIT LESS Booster</measure>
      <time_frame>Enrollment</time_frame>
      <description>Number of participants participating in the SIT LESS Booster study compared to the number of eligible participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average wear time of the Activ8 in the SIT LESS Booster group</measure>
      <time_frame>During the 3-week SIT LESS Booster program</time_frame>
      <description>Adherence to the use of the Activ8 (wear time) measured during the intervention period in the intervention group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of completed telephone calls in the SIT LESS Booster group</measure>
      <time_frame>During the 3-week SIT LESS Booster program</time_frame>
      <description>Number of completed telephone calls of participants in the SIT LESS Booster group</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will receive usual care alone</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SIT LESS Booster</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SIT LESS Booster</intervention_name>
      <description>Patients allocated to the SIT LESS Booster group receive usual care in combination with the SIT LESS Booster program.&#xD;
  The SIT LESS Booster program consists of: 1) The use of the pocket-worn activity tracker (Activ8sit). The activity tracker can be connected to an app to track the daily sitting time. Besides, the device buzzes when a person sits more than 30 consective minutes a s a reminder to stand up and move; 2) Telephone consultation (TC1) during which the researcher and patients will reactivate knowledge on the detrimental health effects of SB, discuss patients' personal goals and motivation, and collaboratively set action plans for reducing SB in the upcoming week (±20 minutes); and 3) Weekly telephone calls (TC2 and TC3) to evaluate sedentery behaviour of the preceding week (±10 minutes).&#xD;
  The SIT LESS Booster will be delivered completely remote</description>
      <arm_group_label>SIT LESS Booster</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Participation in the SIT LESS intervention group of the SIT LESS study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to give informed consent&#xD;
  &#xD;
            -  Wheelchair-bounded / not physically able to stand or walk.&#xD;
  &#xD;
            -  Language barrier&#xD;
  &#xD;
            -  Coronary arterial bypass graft surgery expected within 8 weeks after inclusion&#xD;
  &#xD;
            -  New York Heart Association class III or IV heart failure&#xD;
  &#xD;
            -  Participation in another interventional study targeting SB or PA&#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>Thijs MH Eijsvogels, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radboud University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sophie H Kroesen, MSc</last_name>
      <phone>+31 24 36 14 273</phone>
      <email>sophie.kroesen@radboudumc.nl</email>
    </overall_contact>
    <reference>
      <citation>van Bakel BMA, Kroesen SH, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, Dam J, Janssen AM, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Sedentary Behaviour Intervention as a Personalised Secondary Prevention Strategy (SIT LESS) for patients with coronary artery disease participating in cardiac rehabilitation: rationale and design of the SIT LESS randomised clinical trial. BMJ Open Sport Exerc Med. 2022 May 24;8(2):e001364. doi: 10.1136/bmjsem-2022-001364. eCollection 2022.</citation>
      <PMID>35692440</PMID>
    </reference>
    <reference>
      <citation>van Bakel BMA, Kroesen SH, Bakker EA, van Miltenburg RV, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Effectiveness of an intervention to reduce sedentary behaviour as a personalised secondary prevention strategy for patients with coronary artery disease: main outcomes of the SIT LESS randomised clinical trial. Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):17. doi: 10.1186/s12966-023-01419-z.</citation>
      <PMID>36788615</PMID>
    </reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac rehabilitation</keyword>
    <keyword>e-Health</keyword>
    <keyword>Prevention</keyword>
    <keyword>Sedentary lifestyle</keyword>
    <keyword>Physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>In line with the Open Science initiative and FAIR principles, IPD will be available on reasonable request via the corresponding author.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>IPD will be availabe after publication of the results by the research team.</ipd_time_frame>
      <ipd_access_criteria>All data will be stored in the Digital Research Environment (DRE, mydre. org), an online, cloud- based, globally available research platform. The DRE facilitates users to collaborate on research projects within the boundaries of data management regulations (General Data Protection Regulation and Good Clinical Practice compliant) in a flexible and safe way regarding security, Information and Communication Technology (ICT) infrastructure and audit trail.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06038188
  org study id: NL72604.091.20
  secondary id: #2017T051
  nct id: NCT06038188
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the effect of a booster program aiming to
        lower daily sitting time (SIT LESS Booster program) compared to usual care in patient with
        coronary heart problems. The main question it aims to answer is: What is the effect of the
        SIT LESS Booster on sedentary time and physical activity levels in patient with coronary
        artery disease who participated in cardiac rehabilitation.
  
        Participants will be randomized into 2 groups:
  
          1. Control group who receives usual care;
  
          2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster
             program.
  
        Objectively measured changes in daily sitting time from pre- to post SIT LESS Booster will be
        compared between groups to see if participants in the SIT LESS Booster group are able to
        reduce daily sedentary time more compared to participants in the control group.
  High levels of sedentary time (ST) are observed in patients with coronary artery disease
        (CAD) and are associated with adverse health outcomes. Behavioural interventions targeting ST
        are effective in the short-term, but effects seem to diminish at long-term follow-up.
        Short-term (telephonic) booster programs can induce sustainable physical activity behavioural
        changes. However, the effects of a booster ST reduction program are unknown. Therefore, we
        aim to assess the effect of the SIT LESS Booster on sedentary time and physical activity
        levels in patient with coronary artery disease who participated in cardiac rehabilitation.
  
        All participants took already part in a special cardiac rehabilitation program aiming to
        lower daily sitting time between May 2021 and April 2022. For this study, they will be
        randomized into 2 groups:
  
          1. Control group who receives usual care;
  
          2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster
             program.
  
        The SIT LESS Booster program consists of:
  
          -  Telephone consultation in which the participants are informed about the negative effects
             of high daily sitting time, discuss personal goals to lower daily sitting time and make
             an action plan to reach the goals.
  
          -  Use of a pocket-worn activity tracker to get insight in their own daily sitting time.
             The activity tracker can be connected to a smartphone application. Besides, the activity
             tracker buzzes when a person sits more than 30 consecutive minutes as a reminder to
             stand up.
  
          -  Weekly telephone calls to discuss the progress regarding their personal sit less goals.
  
        In both groups, daily sitting time will be measured at the start of the study and at the end
        of the SIT LESS Booster program using the ActivPAL.
  
        Data analysis will be conducted using R and p-values of <0.05 will be considered
        statistically significant. Changes in daily ST will be compared between groups using a linear
        mixed model.
  
        This trial was approved by the Medical Ethics Committee of the Radboud university medical
        center (NL72604.091.20)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Daily Sedentary time (h/day)
  time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
  description: Daily sedentary time as measured with the ActivPAL during 7 days
  measure: Number of prolonged sedentary bouts per day
  time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
  description: Daily number of prolonged sedentary bouts (>30 min/day) as measured with the ActivPAL during 7 days
  measure: Prevalence of a sitting time >9.5 h/day
  time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
  description: Prevalence of an average sitting time >9.5 h/day measured by the ActivPAL for 7 consective days
  measure: daily light-intensity physical activity time (h/day)
  time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
  description: Daily time spent in light-intensity physical activity (<3 METs) measured by the ActivPAL for 7 consective days
  measure: daily moderate-to-vigorous-intensity physical activity time (h/day)
  time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
  description: Daily time spent in moderate to vigorous intensity physical activity (>3 METs) measured by the ActivPAL for 7 consective days
  measure: daily step count (steps/day)
  time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
  description: daily step count measured by the ActivPAL for 7 consective days
  measure: Uptake of the SIT LESS Booster
  time frame: Enrollment
  description: Number of participants participating in the SIT LESS Booster study compared to the number of eligible participants
  measure: Average wear time of the Activ8 in the SIT LESS Booster group
  time frame: During the 3-week SIT LESS Booster program
  description: Adherence to the use of the Activ8 (wear time) measured during the intervention period in the intervention group
  measure: Number of completed telephone calls in the SIT LESS Booster group
  time frame: During the 3-week SIT LESS Booster program
  description: Number of completed telephone calls of participants in the SIT LESS Booster group
  arm group label: Control group
  arm group type: No Intervention
  description: The control group will receive usual care alone
  arm group label: SIT LESS Booster
  arm group type: Experimental
  description: The intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program.
  intervention type: Behavioral
  intervention name: SIT LESS Booster
  description: Patients allocated to the SIT LESS Booster group receive usual care in combination with the SIT LESS Booster program.
  The SIT LESS Booster program consists of: 1) The use of the pocket-worn activity tracker (Activ8sit). The activity tracker can be connected to an app to track the daily sitting time. Besides, the device buzzes when a person sits more than 30 consective minutes a s a reminder to stand up and move; 2) Telephone consultation (TC1) during which the researcher and patients will reactivate knowledge on the detrimental health effects of SB, discuss patients' personal goals and motivation, and collaboratively set action plans for reducing SB in the upcoming week (±20 minutes); and 3) Weekly telephone calls (TC2 and TC3) to evaluate sedentery behaviour of the preceding week (±10 minutes).
  The SIT LESS Booster will be delivered completely remote
  arm group label: SIT LESS Booster
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thijs MH Eijsvogels, PhD
  role: Principal Investigator
  affiliation: Radboud University Medical Center
  last name: Sophie H Kroesen, MSc
  phone: +31 24 36 14 273
  email: sophie.kroesen@radboudumc.nl
  citation: van Bakel BMA, Kroesen SH, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, Dam J, Janssen AM, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Sedentary Behaviour Intervention as a Personalised Secondary Prevention Strategy (SIT LESS) for patients with coronary artery disease participating in cardiac rehabilitation: rationale and design of the SIT LESS randomised clinical trial. BMJ Open Sport Exerc Med. 2022 May 24;8(2):e001364. doi: 10.1136/bmjsem-2022-001364. eCollection 2022.
  PMID: 35692440
  citation: van Bakel BMA, Kroesen SH, Bakker EA, van Miltenburg RV, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Effectiveness of an intervention to reduce sedentary behaviour as a personalised secondary prevention strategy for patients with coronary artery disease: main outcomes of the SIT LESS randomised clinical trial. Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):17. doi: 10.1186/s12966-023-01419-z.
  PMID: 36788615
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  sharing ipd: Yes
  ipd description: In line with the Open Science initiative and FAIR principles, IPD will be available on reasonable request via the corresponding author.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: IPD will be availabe after publication of the results by the research team.
  ipd access criteria: All data will be stored in the Digital Research Environment (DRE, mydre. org), an online, cloud- based, globally available research platform. The DRE facilitates users to collaborate on research projects within the boundaries of data management regulations (General Data Protection Regulation and Good Clinical Practice compliant) in a flexible and safe way regarding security, Information and Communication Technology (ICT) infrastructure and audit trail.