<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/NCT02246400</url>
  </required_header>
  <id_info>
    <org_study_id># 14-01-290</org_study_id>
    <nct_id>NCT02246400</nct_id>
  </id_info>
  <brief_title>CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact</brief_title>
  <acronym>eCMP</acronym>
  <official_title>CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palo Alto Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Palo Alto Medical Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The eCMP Pilot aims to study the feasibility and potential effectiveness of an&#xD;
      electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among&#xD;
      adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The eCMP is an evidence-based lifestyle intervention using a holistic,&#xD;
      mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using&#xD;
      existing web and mobile technologies. In this pragmatic randomized controlled trial,&#xD;
      participants will be recruited from primary care patients of an integrated ambulatory care&#xD;
      system. They will be randomly assigned to receive the eCMP upon completion of baseline data&#xD;
      collection (the Immediate Intervention group) or after 3 months (the Delayed Intervention&#xD;
      group). All participants will be assessed at 0, 3 and 6 months. Outcomes include common&#xD;
      cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose),&#xD;
      health behaviors (e.g., dietary intake and physical activity), and indicators of eCMP&#xD;
      engagement and adherence (e.g., attendance and self-monitoring).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in measure of Health-related quality of life from baseline to 6-months follow up.</measure>
    <time_frame>6-months</time_frame>
    <description>SF-8 questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in composite measure of Metabolic Syndrome</measure>
    <time_frame>6-months.</time_frame>
    <description>Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Baseline, 3-months, and 6-months.</time_frame>
    <description>Nutrition Data System for Research (NDSR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline, 3-months, and 6-months.</time_frame>
    <description>Seven-Day Physical Activity Recall (PAR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention adherence</measure>
    <time_frame>3-months and 6-months.</time_frame>
    <description>Intervention session attendance of virtual classes and in-person physical activity classes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Pre-diabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Delayed Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care for first three months. Initiation of the eCMP after the 3-month time point.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initiation of the eCMP immediately upon completion of baseline data collection and randomization</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eCMP</intervention_name>
    <description>eCMP is a 6-month lifestyle intervention designed and led by a team of experienced health professionals, including physicians, researchers, dietitians, and registered nurses. The program consists of weekly home and class activities delivered through online or take-home videos, video conferencing, and/or in-person sessions.</description>
    <arm_group_label>Delayed Intervention</arm_group_label>
    <arm_group_label>Immediate Intervention</arm_group_label>
    <other_name>Electronically-mediated CardioMetabolic Program (eCMP)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking adults aged 18+ years&#xD;
&#xD;
          -  High-risk primary prevention: BMI 35+ and prediabetes (including hx of gestational&#xD;
             diabetes) and/or metabolic syndrome&#xD;
&#xD;
          -  Secondary prevention: BMI 30+ and type 2 diabetes and/or cardiovascular disease&#xD;
&#xD;
          -  Able and willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical determination that the study is inappropriate or unsafe for the patient&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Safety concerns related to significant physical or mental health issues or life&#xD;
             expectancy of less than 12 months&#xD;
&#xD;
          -  Currently pregnant or lactating&#xD;
&#xD;
          -  No regular telephone or broadband Internet access or otherwise unable to participate&#xD;
             in the intervention&#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>Jun Ma, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palo Alto Medical Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tak Poon, MD, PharmD, ABIHM, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palo Alto Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation, Mills Peninsula Division</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>March 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>May 29, 2015</last_update_submitted>
  <last_update_submitted_qc>May 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eCMP</keyword>
  <keyword>eHealth</keyword>
  <keyword>mHealth</keyword>
  <keyword>Lifestyle intervention</keyword>
  <keyword>Cardiometabolic risk reduction</keyword>
  <keyword>PAMF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Prediabetic State</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/NCT02246400
org study id: # 14-01-290
nct id: NCT02246400
lead sponsor: 
has dmc: No
The eCMP Pilot aims to study the feasibility and potential effectiveness of an
      electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among
      adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.
The eCMP is an evidence-based lifestyle intervention using a holistic,
      mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using
      existing web and mobile technologies. In this pragmatic randomized controlled trial,
      participants will be recruited from primary care patients of an integrated ambulatory care
      system. They will be randomly assigned to receive the eCMP upon completion of baseline data
      collection (the Immediate Intervention group) or after 3 months (the Delayed Intervention
      group). All participants will be assessed at 0, 3 and 6 months. Outcomes include common
      cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose),
      health behaviors (e.g., dietary intake and physical activity), and indicators of eCMP
      engagement and adherence (e.g., attendance and self-monitoring).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in measure of Health-related quality of life from baseline to 6-months follow up.
time frame: 6-months
description: SF-8 questionnaire
measure: Change in composite measure of Metabolic Syndrome
time frame: 6-months.
description: Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.)
measure: Dietary Intake
time frame: Baseline, 3-months, and 6-months.
description: Nutrition Data System for Research (NDSR).
measure: Physical Activity
time frame: Baseline, 3-months, and 6-months.
description: Seven-Day Physical Activity Recall (PAR).
measure: Intervention adherence
time frame: 3-months and 6-months.
description: Intervention session attendance of virtual classes and in-person physical activity classes.
measure: Body weight
time frame: Baseline, 3 months, and 6 months
arm group label: Delayed Intervention
arm group type: Active Comparator
description: Usual care for first three months. Initiation of the eCMP after the 3-month time point.
arm group label: Immediate Intervention
arm group type: Experimental
description: Initiation of the eCMP immediately upon completion of baseline data collection and randomization
intervention type: Behavioral
intervention name: eCMP
description: eCMP is a 6-month lifestyle intervention designed and led by a team of experienced health professionals, including physicians, researchers, dietitians, and registered nurses. The program consists of weekly home and class activities delivered through online or take-home videos, video conferencing, and/or in-person sessions.
arm group label: Delayed Intervention
arm group label: Immediate Intervention
other name: Electronically-mediated CardioMetabolic Program (eCMP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Ma, MD, PhD
role: Principal Investigator
affiliation: Palo Alto Medical Foundation
last name: Tak Poon, MD, PharmD, ABIHM, FACC
role: Principal Investigator
affiliation: Palo Alto Medical Foundation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus
mesh term: Metabolic Syndrome
mesh term: Prediabetic State