<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/NCT04445168</url>
  </required_header>
  <id_info>
    <org_study_id>KPSC IRB#10106M</org_study_id>
    <nct_id>NCT04445168</nct_id>
  </id_info>
  <brief_title>Randomized Trial of Exercise Promotion in Primary Care</brief_title>
  <acronym>EPPC</acronym>
  <official_title>Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</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>
      Millions of Americans have diabetes or prediabetes, for which regular physical activity can&#xD;
      reduce risks of unfavorable outcomes of these conditions. This study will test the effects of&#xD;
      an evidence-based intervention in the primary care setting on increasing physical activity&#xD;
      among these individuals. If effective, it can be broadly implemented in primary care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Moderate to vigorous physical activity (MVPA)</measure>
    <time_frame>12 months</time_frame>
    <description>Accelerometer-derived 7-day MVPA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Moderate to vigorous physical activity (MVPA)</measure>
    <time_frame>24 months</time_frame>
    <description>Accelerometer-derived 7-day MVPA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>12 months</time_frame>
    <description>Weight assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>24 months</time_frame>
    <description>Weight assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Systolic blood pressure assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>24 months</time_frame>
    <description>Systolic blood pressure assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Diastolic blood pressure assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>24 months</time_frame>
    <description>Diastolic blood pressure assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12 months</time_frame>
    <description>HbA1c assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>24 months</time_frame>
    <description>HbA1c assessed from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">780</enrollment>
  <condition>PreDiabetes</condition>
  <condition>Diabetes</condition>
  <condition>Sedentary Behavior</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-based motivational interviews</intervention_name>
    <description>2-year telephone-based motivational interviews to increase physical activity.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per&#xD;
        week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least&#xD;
        12 months, Receives primary care at the Fontana Medical Center, Body mass index between&#xD;
        18.5 and 40 kg/m2,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Current use of insulin, Cardiovascular event in the past 6 months or other condition that&#xD;
        limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years,&#xD;
        Current participation in another clinical trial or research study, Plans to move out of the&#xD;
        area in next 2 years,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Deborah R Young, PhD</last_name>
    <phone>626-564-3887</phone>
    <email>deborah.r.young@kp.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Melissa Preciado, MPH</last_name>
    <phone>626-564-3000</phone>
    <email>melissa.x.preciado@kp.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kaiser Permanente Southern California</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>911010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deborah R Young, PhD</last_name>
      <phone>626-564-3887</phone>
      <email>deborah.r.young@kp.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Randomized trial</keyword>
  <keyword>Primary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT04445168
org study id: KPSC IRB#10106M
nct id: NCT04445168
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Millions of Americans have diabetes or prediabetes, for which regular physical activity can
      reduce risks of unfavorable outcomes of these conditions. This study will test the effects of
      an evidence-based intervention in the primary care setting on increasing physical activity
      among these individuals. If effective, it can be broadly implemented in primary care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Moderate to vigorous physical activity (MVPA)
time frame: 12 months
description: Accelerometer-derived 7-day MVPA
measure: Moderate to vigorous physical activity (MVPA)
time frame: 24 months
description: Accelerometer-derived 7-day MVPA
measure: Weight
time frame: 12 months
description: Weight assessed from electronic medical records
measure: Weight
time frame: 24 months
description: Weight assessed from electronic medical records
measure: Systolic blood pressure
time frame: 12 months
description: Systolic blood pressure assessed from electronic medical records
measure: Systolic blood pressure
time frame: 24 months
description: Systolic blood pressure assessed from electronic medical records
measure: Diastolic blood pressure
time frame: 12 months
description: Diastolic blood pressure assessed from electronic medical records
measure: Diastolic blood pressure
time frame: 24 months
description: Diastolic blood pressure assessed from electronic medical records
measure: HbA1c
time frame: 12 months
description: HbA1c assessed from electronic medical records
measure: HbA1c
time frame: 24 months
description: HbA1c assessed from electronic medical records
measure: Health-related quality of life
time frame: 12 months
description: Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life
measure: Health-related quality of life
time frame: 24 months
description: Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life
arm group label: Usual Care
arm group type: No Intervention
description: Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.
arm group label: Intervention
arm group type: Experimental
description: Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.
intervention type: Behavioral
intervention name: Telephone-based motivational interviews
description: 2-year telephone-based motivational interviews to increase physical activity.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Deborah R Young, PhD
phone: 626-564-3887
email: deborah.r.young@kp.org
last name: Melissa Preciado, MPH
phone: 626-564-3000
email: melissa.x.preciado@kp.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No