<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/NCT03815955</url>
  </required_header>
  <id_info>
    <org_study_id>112907</org_study_id>
    <nct_id>NCT03815955</nct_id>
  </id_info>
  <brief_title>Reducing Sedentary Behaviour in Patients With Type II Diabetes</brief_title>
  <official_title>Reducing Sedentary Behaviour at St. Joseph's Primary Care Diabetes Support Program; Effect on Blood Glucose Levels in Patients With Type II Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Joseph's Health Care London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western University, Canada</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>
      The study will implement a prospective one-arm feasibility study. After an initial&#xD;
      eligibility screening by the primary care provider during their intake appointment, new&#xD;
      patients will be invited to participate in an acute intervention to reduce sedentary&#xD;
      behaviour during a group appointment at St. Joseph's Primary Care Diabetes Support (SJHC&#xD;
      PCDSP). Scheduled with up to 10 other people, participants will be encouraged to model the&#xD;
      primary care provider and support team as they engage in minimal sedentary behaviour and&#xD;
      replace sitting with standing and light, incidental movements.&#xD;
&#xD;
      An accelerometer-based sensory (ActivPAL4) will be worn and used to measure the patients'&#xD;
      sedentary behaviour and physical activity patterns, including the duration and frequency of&#xD;
      breaks in sedentary time during the appointment. Capillary blood glucose differences will be&#xD;
      assessed at pre- and post-appointment. A series of paper-pencil questionnaires will also&#xD;
      measure self-efficacy, goal intention, and positive and negative affect at both pre- and&#xD;
      post-appointment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following pre-screening at their intake appointment, if appropriate for a DIGMA and eligible&#xD;
      to participate, new patients to SJHC PCDSP will be invited to attend a DIGMA scheduled&#xD;
      two-weeks post-intake appointment. Participants will provide their written informed consent&#xD;
      and patient demographic information, assessed by questionnaire, during the first hour of&#xD;
      their appointment. With a trained research assistant, the participant will complete a series&#xD;
      of behavioural measures including: the Godin Leisure-Time Exercise Questionnaire (GLTEQ) and&#xD;
      a modified Sedentary Behaviour Questionnaire (SBQ). Standardized anthropometric measurements,&#xD;
      including waist circumference, weight, height, and capillary blood glucose, of all&#xD;
      participants will also be completed separately in an exam room.&#xD;
&#xD;
      Consistent with social learning theory, the primary care provider and the DIGMA support team&#xD;
      will model, demonstrate, and verbalize aspects of increased confidence to perform the 1-hour&#xD;
      appointment in a standing position and offer a variety of strategies to cope and overcome any&#xD;
      feelings of discomfort. Emphasis will be placed on the strategies the primary care models&#xD;
      uses to break sitting with standing and light, incidental movements. It will be anticipated&#xD;
      that the participant will observe cues and relevant information specific to their behaviour&#xD;
      change and engage in minimal sedentary behaviour.&#xD;
&#xD;
      The frequency of breaks and the duration of breaks taken during the scheduled DIGMA will be&#xD;
      measured using an ActivPAL4 monitor, a wearable device that can measure sitting/lying,&#xD;
      standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.&#xD;
&#xD;
      Capillary blood glucose will be measured by the research staff at both pre- and&#xD;
      post-appointment using a glucometer. As patients are not required to restrict their diet&#xD;
      before a standard DIGMA, there will be no restrictions on food and/or drink intake&#xD;
      before/during the morning of, the travel to, and/or during the appointment. Participants will&#xD;
      be asked to self-report the time and what they ate during their last meal in their&#xD;
      demographics questionnaire.&#xD;
&#xD;
      Self-efficacy and positive and negative affect will be self-reported at both pre- and&#xD;
      post-appointment using a scale adapted from the General Self-Efficacy Scale and the Positive&#xD;
      and Negative Affect Schedule (PANAS), respectively. As well, goal intentions of the patients&#xD;
      will be measured using a questionnaire along three dimensions: respondents will refer to a&#xD;
      specific point in time, to the place, and to the degree of behavioural intent that is linked&#xD;
      to the situational context specified by time and place. An example of one of the questions&#xD;
      will be &quot;Over the next week, do you intend to sit less at home?&quot;. Subjects will then indicate&#xD;
      using a 5-point Likert scale the degree to which they endorse this statement (e.g., 1 is not&#xD;
      at all to 5 is completely agree).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Actual">April 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Frequency of Non-Sedentary Behaviour Breaks</measure>
    <time_frame>The ActivPAL4 will be worn during the whole 1-hour DIGMA, and will record the frequency of breaks during this time (60 minutes).</time_frame>
    <description>The frequency of breaks taken from engaging in sedentary behaviour recorded during the scheduled 1-hour appointment with the primary care provider will be measured using the ActivPAL4 monitor, a wearable device specifically designed for sedentary behaviour interventions. The ActivPAL4 can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Sedentary Behaviour Break Time</measure>
    <time_frame>The ActivPAL4 will be worn during the whole 1-hour DIGMA, and will record the duration of breaks during this time (60 minutes).</time_frame>
    <description>The duration of breaks (minutes) taken during the scheduled 1-hour appointment with the primary care provider will be measured using the ActivPAL4 monitor, a wearable device specifically designed for sedentary behaviour interventions. The ActivPAL4 can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Capillary Blood Glucose</measure>
    <time_frame>Capillary blood glucose differences will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).</time_frame>
    <description>Capillary blood glucose (mg/dl) of all participants will be measured by the research staff at both pre- and post-appointment using a Accu-chek Guide meter and test strips (glucometer).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Self-efficacy will be self-measured at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).</time_frame>
    <description>Self-efficacy will be assessed using a scale adapted from the General Self-Efficacy Scale. Participants will rate their confidence to standing for 5 minutes during decreasing periods of time (i.e., +3 hours, 2 hours, 1 hour, &lt;1 hour). An example of one of the statements used will be &quot;I believe that I can stand for 5 minutes every +3hours&quot;. Participants will also rate their confidence to standing and moving for increasing periods of time (i.e., 2 minutes, 5 minutes, 10 minutes, and 20 minutes) over a 2-hour time interval. An example of one of the statements used will be &quot;I believe that I can stand and move for 2 minutes ever 2 hours&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Goal Intentions</measure>
    <time_frame>Goal intentions will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).</time_frame>
    <description>Goal intentions will be measured through the completion of a questionnaire along three dimensions: respondents will refer to a specific point in time, to the place, and to the degree of behavioral intent that is linked to the situational context specified by time and place. An example of one of the statements used will be &quot;Over the next week, I intend to stand more at home&quot;. Subjects will then indicate using a 5-point Likert scale the degree to which they endorse this statement (e.g., 1 is not at all to 5 is completely agree).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect</measure>
    <time_frame>Positive and negative affect will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).</time_frame>
    <description>Positive and negative affect will be self-reported using the 20-item questionnaire, Positive and Negative Affect Schedule (PANAS).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Sedentary Lifestyle</condition>
  <arm_group>
    <arm_group_label>Non-Sedentary Behaviour Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will model the primary care team as they engage in minimal sedentary behaviour and replace sitting with standing and light, incidental movements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants that are limited to standing, due to amputations, diabetic foot pain and ulcers, or sensory diabetic neuropathy, will follow standard care and attend the DIGMA in a seated position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-Sedentary Behaviour Modelling</intervention_name>
    <description>Consistent with social learning theory, the primary care provider and the DIGMA support team will model, demonstrate, and verbalize aspects of increased confidence to perform the 1-hour appointment in a standing position and offer a variety of strategies to cope and overcome any feelings of discomfort. Emphasis will be placed on the strategies the primary care team uses to break sitting with standing and light, incidental movements. It will be anticipated that the participant will observe cues and relevant information specific to their behaviour change and engage in minimal sedentary behaviour.</description>
    <arm_group_label>Non-Sedentary Behaviour Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants, aged 18 years or older, will be eligible if they present diagnostic&#xD;
             criteria according to the Diabetes Canada 2018 Clinical Practice Guidelines for the&#xD;
             Prevention and Management of Diabetes in Canada for type 2 diabetes (diagnosed by any&#xD;
             of the following criteria: glycated hemoglobin (A1C) ≥6.5%, fasting plasma glucose&#xD;
             (FPG) ≥7.0 mmol/L, 2-hour plasma glucose (2hPG) in a 75 g oral glucose tolerance test&#xD;
             (OGTT) ≥11.1 mmol/L, random PG ≥11.1 mmol/L) and would benefit from a DIGMA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with diabetes will be excluded if they are younger than 18 years, have&#xD;
             significant illness, or an inability to communicate in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harry Prapavessis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Western Ontario, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Western Ontario</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Family Medical and Dental Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G 1J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Dr. Harry Prapavessis</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT03815955
org study id: 112907
nct id: NCT03815955
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will implement a prospective one-arm feasibility study. After an initial
      eligibility screening by the primary care provider during their intake appointment, new
      patients will be invited to participate in an acute intervention to reduce sedentary
      behaviour during a group appointment at St. Joseph's Primary Care Diabetes Support (SJHC
      PCDSP). Scheduled with up to 10 other people, participants will be encouraged to model the
      primary care provider and support team as they engage in minimal sedentary behaviour and
      replace sitting with standing and light, incidental movements.

      An accelerometer-based sensory (ActivPAL4) will be worn and used to measure the patients'
      sedentary behaviour and physical activity patterns, including the duration and frequency of
      breaks in sedentary time during the appointment. Capillary blood glucose differences will be
      assessed at pre- and post-appointment. A series of paper-pencil questionnaires will also
      measure self-efficacy, goal intention, and positive and negative affect at both pre- and
      post-appointment.
Following pre-screening at their intake appointment, if appropriate for a DIGMA and eligible
      to participate, new patients to SJHC PCDSP will be invited to attend a DIGMA scheduled
      two-weeks post-intake appointment. Participants will provide their written informed consent
      and patient demographic information, assessed by questionnaire, during the first hour of
      their appointment. With a trained research assistant, the participant will complete a series
      of behavioural measures including: the Godin Leisure-Time Exercise Questionnaire (GLTEQ) and
      a modified Sedentary Behaviour Questionnaire (SBQ). Standardized anthropometric measurements,
      including waist circumference, weight, height, and capillary blood glucose, of all
      participants will also be completed separately in an exam room.

      Consistent with social learning theory, the primary care provider and the DIGMA support team
      will model, demonstrate, and verbalize aspects of increased confidence to perform the 1-hour
      appointment in a standing position and offer a variety of strategies to cope and overcome any
      feelings of discomfort. Emphasis will be placed on the strategies the primary care models
      uses to break sitting with standing and light, incidental movements. It will be anticipated
      that the participant will observe cues and relevant information specific to their behaviour
      change and engage in minimal sedentary behaviour.

      The frequency of breaks and the duration of breaks taken during the scheduled DIGMA will be
      measured using an ActivPAL4 monitor, a wearable device that can measure sitting/lying,
      standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.

      Capillary blood glucose will be measured by the research staff at both pre- and
      post-appointment using a glucometer. As patients are not required to restrict their diet
      before a standard DIGMA, there will be no restrictions on food and/or drink intake
      before/during the morning of, the travel to, and/or during the appointment. Participants will
      be asked to self-report the time and what they ate during their last meal in their
      demographics questionnaire.

      Self-efficacy and positive and negative affect will be self-reported at both pre- and
      post-appointment using a scale adapted from the General Self-Efficacy Scale and the Positive
      and Negative Affect Schedule (PANAS), respectively. As well, goal intentions of the patients
      will be measured using a questionnaire along three dimensions: respondents will refer to a
      specific point in time, to the place, and to the degree of behavioural intent that is linked
      to the situational context specified by time and place. An example of one of the questions
      will be "Over the next week, do you intend to sit less at home?". Subjects will then indicate
      using a 5-point Likert scale the degree to which they endorse this statement (e.g., 1 is not
      at all to 5 is completely agree).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Frequency of Non-Sedentary Behaviour Breaks
time frame: The ActivPAL4 will be worn during the whole 1-hour DIGMA, and will record the frequency of breaks during this time (60 minutes).
description: The frequency of breaks taken from engaging in sedentary behaviour recorded during the scheduled 1-hour appointment with the primary care provider will be measured using the ActivPAL4 monitor, a wearable device specifically designed for sedentary behaviour interventions. The ActivPAL4 can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.
measure: Non-Sedentary Behaviour Break Time
time frame: The ActivPAL4 will be worn during the whole 1-hour DIGMA, and will record the duration of breaks during this time (60 minutes).
description: The duration of breaks (minutes) taken during the scheduled 1-hour appointment with the primary care provider will be measured using the ActivPAL4 monitor, a wearable device specifically designed for sedentary behaviour interventions. The ActivPAL4 can measure sitting/lying, standing, and walking time, sit-to-stand and stand-to-sit transition counts and step counts.
measure: Capillary Blood Glucose
time frame: Capillary blood glucose differences will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).
description: Capillary blood glucose (mg/dl) of all participants will be measured by the research staff at both pre- and post-appointment using a Accu-chek Guide meter and test strips (glucometer).
measure: Self-efficacy
time frame: Self-efficacy will be self-measured at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).
description: Self-efficacy will be assessed using a scale adapted from the General Self-Efficacy Scale. Participants will rate their confidence to standing for 5 minutes during decreasing periods of time (i.e., +3 hours, 2 hours, 1 hour, <1 hour). An example of one of the statements used will be "I believe that I can stand for 5 minutes every +3hours". Participants will also rate their confidence to standing and moving for increasing periods of time (i.e., 2 minutes, 5 minutes, 10 minutes, and 20 minutes) over a 2-hour time interval. An example of one of the statements used will be "I believe that I can stand and move for 2 minutes ever 2 hours".
measure: Goal Intentions
time frame: Goal intentions will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).
description: Goal intentions will be measured through the completion of a questionnaire along three dimensions: respondents will refer to a specific point in time, to the place, and to the degree of behavioral intent that is linked to the situational context specified by time and place. An example of one of the statements used will be "Over the next week, I intend to stand more at home". Subjects will then indicate using a 5-point Likert scale the degree to which they endorse this statement (e.g., 1 is not at all to 5 is completely agree).
measure: Positive and Negative Affect
time frame: Positive and negative affect will be assessed at the start of their DIGMA (0 minutes), and will be re-assessed after their appointment (60 minutes).
description: Positive and negative affect will be self-reported using the 20-item questionnaire, Positive and Negative Affect Schedule (PANAS).
arm group label: Non-Sedentary Behaviour Group
arm group type: Experimental
description: Participants in this arm will model the primary care team as they engage in minimal sedentary behaviour and replace sitting with standing and light, incidental movements.
arm group label: Standard Care Control Group
arm group type: No Intervention
description: Participants that are limited to standing, due to amputations, diabetic foot pain and ulcers, or sensory diabetic neuropathy, will follow standard care and attend the DIGMA in a seated position.
intervention type: Behavioral
intervention name: Non-Sedentary Behaviour Modelling
description: Consistent with social learning theory, the primary care provider and the DIGMA support team will model, demonstrate, and verbalize aspects of increased confidence to perform the 1-hour appointment in a standing position and offer a variety of strategies to cope and overcome any feelings of discomfort. Emphasis will be placed on the strategies the primary care team uses to break sitting with standing and light, incidental movements. It will be anticipated that the participant will observe cues and relevant information specific to their behaviour change and engage in minimal sedentary behaviour.
arm group label: Non-Sedentary Behaviour Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Harry Prapavessis, PhD
role: Principal Investigator
affiliation: University of Western Ontario, Canada
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Dr. Harry Prapavessis
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2