<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/NCT04454957</url>
  </required_header>
  <id_info>
    <org_study_id>20-X-96</org_study_id>
    <nct_id>NCT04454957</nct_id>
  </id_info>
  <brief_title>Mastering Diabetes Study</brief_title>
  <official_title>Effectiveness of a Virtual Therapeutic Lifestyle Change Program for Diabetes and Prediabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Memorial Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio University</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>
      This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a&#xD;
      therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes.&#xD;
&#xD;
      Lifestyle change, focused on dietary change, physical activity, stress management and control&#xD;
      of unhealthy substances has been demonstrated effective in preventing the progression of&#xD;
      prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a nonrandomized controlled study. Participants will self select to be a part of&#xD;
      this intervention. The control data will be aggregated matched data from participants in the&#xD;
      corporate wellness program at Memorial Health System, who choose not to participate in the&#xD;
      intervention.&#xD;
&#xD;
      Study participants will have met the inclusion criteria. Potential participants will be&#xD;
      provided with a short summary of this program as a potential activity for their&#xD;
      participation, with a link leading to a landing page, which will explain the study in more&#xD;
      detail, and will include a link to the consent.&#xD;
&#xD;
      If the potential participant is interested, they can click the link to move to the on line&#xD;
      consent. If they agree to the consent, they will be taken to an on line HIPAA release form,&#xD;
      which will also need an electronic agreement to be enrolled into the study signified by&#xD;
      typing in the participant's name and date of birth.&#xD;
&#xD;
      Once this is completed, an email with an enrollment code and link to Mastering Diabetes will&#xD;
      be sent the participant.&#xD;
&#xD;
      Mastering Diabetes Program Description:&#xD;
&#xD;
      The Mastering Diabetes Program is based on the Mastering Diabetes Method, which is based on&#xD;
      almost 100 years of evidence based research demonstrating the effectiveness of a low-fat,&#xD;
      plant-based, whole-food diet to reverse insulin resistance. Members are provided with a&#xD;
      step-by-step online course that educates them how to transition to a low-fat, plant-based,&#xD;
      whole-food lifestyle and reduce the overwhelm associated with ineffective pharmaceutical&#xD;
      medication and ineffective dietary advice.&#xD;
&#xD;
      The online course provides members with detailed information about the root cause of insulin&#xD;
      resistance, the effect of a high-fat diet on increasing insulin resistance, how to achieve&#xD;
      excellent blood glucose values in the short-term and in the long-term, what laboratory tests&#xD;
      to get to measure progress, an overview of oral diabetes medication and insulin, how to track&#xD;
      hour-by-hour decisions for excellent blood glucose control, how to lose weight permanently&#xD;
      using a low-fat, plant-based, whole-food diet, how to buy food, where to buy food, how to&#xD;
      prepare food easily, the benefits of intermittent fasting for improved insulin sensitivity,&#xD;
      how to perform an intermittent fast for excellent results, how to adopt an exercise regimen,&#xD;
      how to control your blood glucose before, during, and after exercise, how to change your&#xD;
      breakfast, lunch, dinner, and also provides members with a collection of delicious and simple&#xD;
      recipes.&#xD;
&#xD;
      The program also provides members with direct access to expert coaches via an online&#xD;
      community containing thousands of others living with all forms of diabetes, including type 1&#xD;
      diabetes, type 1.5 diabetes, prediabetes, type 2 diabetes, and gestational diabetes. In&#xD;
      addition, members get access to live biweekly Q&amp;A videoconferences in which they can interact&#xD;
      with coaches and personalize their experience. The cost of full coaching program is $399 for&#xD;
      the first 3 months, then $99 per month thereafter.&#xD;
&#xD;
      Participants, having enrolled in the wellness program, will already, as a part of that study,&#xD;
      have agreed to have data collected at baseline and yearly thereafter, including BMI, blood&#xD;
      pressure, resting pulse, lipid panel, hemoglobin A1c, health risk assessment survey,&#xD;
      absenteeism and health claims data at baseline and yearly thereafter. If not collected within&#xD;
      60 days, a new set of data will be collected to serve as baseline for this study. This is not&#xD;
      specific for this study, but is the case for any new program activity that a participant in&#xD;
      the corporate wellness study begins.&#xD;
&#xD;
      Specifically for this study the health risk assessment data collection (including lab&#xD;
      analysis) will also be repeated at 12 weeks. The lab work is accomplished at any MHS lab&#xD;
      facility, according to current medical system standards.&#xD;
&#xD;
      Participant health claims data will also be evaluated, beginning with the prior year's data,&#xD;
      if available from MHS Human Resources, being utilized as a baseline, and followed for the&#xD;
      subsequent years of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2040</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Nonrandomized controlled interventional study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>up to 20 years</time_frame>
    <description>glycosylated hemoglobin measured from venous blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>up to 20 years</time_frame>
    <description>Body mass index calculated from height and weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthcare expenditures</measure>
    <time_frame>up to 20 years</time_frame>
    <description>Monetary amount spent for healthcare</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>Measured from a lipid panel done on venous blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low density lipoprotein cholesterol</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>Calculated from a lipid panel done on venous blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High density lipoprotein cholesterol</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>Measured from a lipid panel done on venous blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>Measured from a lipid panel done on venous blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise level</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>Amount of time spent per week in moderate to vigorous physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Recall</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>Daily or weekly average of foods consumed during the last 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>mood screening questions; two for anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>baseline, 12 weeks, 1 yearly, then yearly for up to 20 years</time_frame>
    <description>mood screening questions; two for depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Mastering Diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults (hospital employees, their spouses, and community members) who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen to participate in Mastering Diabetes. They may or may not be receiving additional usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Employees and spouses of the hospital system who are participating in the employee wellness program, who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen not to participate in Mastering Diabetes. They may or may not be receiving additional usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mastering Diabetes</intervention_name>
    <description>Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.</description>
    <arm_group_label>Mastering Diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 years at enrollment&#xD;
&#xD;
          -  Has a diagnosis of diabetes or prediabetes or a HbA1c of 5.7 or higher.&#xD;
&#xD;
          -  Are able to participate in physical activity.&#xD;
&#xD;
          -  Are willing to use a smartphone or computer to access the online education modules and&#xD;
             online community, and have reliable daily Internet access with a device with a webcam&#xD;
&#xD;
          -  Have an email account and an Internet connection at home&#xD;
&#xD;
          -  Are able to purchase and transport fresh produce from a local grocery store to their&#xD;
             house on a weekly basis&#xD;
&#xD;
          -  Are able to prepare food in their house or get help preparing food in their house&#xD;
             following recipes and meal examples provided in the online course&#xD;
&#xD;
          -  Are open-minded about eating a plant-based diet, performing periodic intermittent&#xD;
             fasting (16-24 hours, once a week),&#xD;
&#xD;
          -  Are willing to increase movement of their body 5-6 days per week&#xD;
&#xD;
          -  Are willing to participate in an online community for support and coaching&#xD;
&#xD;
          -  Are willing to participate in biweekly videoconferencing for support and coaching&#xD;
&#xD;
          -  Are willing to be courteous and respectful to others in the online community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has been told by a medical provider to not participate in physical activity.&#xD;
&#xD;
          -  Has a medical condition that prevents walking at least a mile a day.&#xD;
&#xD;
          -  Deemed unsuitable to exercise by Dr. Drozek or other members of the wellness team.&#xD;
&#xD;
          -  Has a diagnosis of dementia.&#xD;
&#xD;
          -  Is pregnant or planning to become pregnant during the program&#xD;
&#xD;
          -  Does not speak or understand English&#xD;
&#xD;
          -  Advanced renal disease (stage 4 or 5) with or without hemodialysis&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Has inflammatory bowel disease (Crohns disease, ulcerative colitis)&#xD;
&#xD;
          -  Is fed by a feeding tube&#xD;
&#xD;
          -  Is taking Coumadin or warfarin&#xD;
&#xD;
          -  Inability to use email, a smartphone, or the Internet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David Drozek, DO</last_name>
    <phone>678-447-2509</phone>
    <email>drozek@ohio.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ohio University</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David S Drozek, DO</last_name>
      <phone>678-447-2509</phone>
      <email>drozek@ohio.edu</email>
    </contact>
    <investigator>
      <last_name>David S Drozek, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/34366745/</url>
    <description>Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot Study</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio University</investigator_affiliation>
    <investigator_full_name>David Drozek</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>prediabetes</keyword>
  <keyword>glycemia</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>plant-based diet</keyword>
  <keyword>nutrition</keyword>
  <keyword>exercise</keyword>
  <keyword>obesity / overweight</keyword>
  <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>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04454957
org study id: 20-X-96
nct id: NCT04454957
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a
      therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes.

      Lifestyle change, focused on dietary change, physical activity, stress management and control
      of unhealthy substances has been demonstrated effective in preventing the progression of
      prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).
This will be a nonrandomized controlled study. Participants will self select to be a part of
      this intervention. The control data will be aggregated matched data from participants in the
      corporate wellness program at Memorial Health System, who choose not to participate in the
      intervention.

      Study participants will have met the inclusion criteria. Potential participants will be
      provided with a short summary of this program as a potential activity for their
      participation, with a link leading to a landing page, which will explain the study in more
      detail, and will include a link to the consent.

      If the potential participant is interested, they can click the link to move to the on line
      consent. If they agree to the consent, they will be taken to an on line HIPAA release form,
      which will also need an electronic agreement to be enrolled into the study signified by
      typing in the participant's name and date of birth.

      Once this is completed, an email with an enrollment code and link to Mastering Diabetes will
      be sent the participant.

      Mastering Diabetes Program Description:

      The Mastering Diabetes Program is based on the Mastering Diabetes Method, which is based on
      almost 100 years of evidence based research demonstrating the effectiveness of a low-fat,
      plant-based, whole-food diet to reverse insulin resistance. Members are provided with a
      step-by-step online course that educates them how to transition to a low-fat, plant-based,
      whole-food lifestyle and reduce the overwhelm associated with ineffective pharmaceutical
      medication and ineffective dietary advice.

      The online course provides members with detailed information about the root cause of insulin
      resistance, the effect of a high-fat diet on increasing insulin resistance, how to achieve
      excellent blood glucose values in the short-term and in the long-term, what laboratory tests
      to get to measure progress, an overview of oral diabetes medication and insulin, how to track
      hour-by-hour decisions for excellent blood glucose control, how to lose weight permanently
      using a low-fat, plant-based, whole-food diet, how to buy food, where to buy food, how to
      prepare food easily, the benefits of intermittent fasting for improved insulin sensitivity,
      how to perform an intermittent fast for excellent results, how to adopt an exercise regimen,
      how to control your blood glucose before, during, and after exercise, how to change your
      breakfast, lunch, dinner, and also provides members with a collection of delicious and simple
      recipes.

      The program also provides members with direct access to expert coaches via an online
      community containing thousands of others living with all forms of diabetes, including type 1
      diabetes, type 1.5 diabetes, prediabetes, type 2 diabetes, and gestational diabetes. In
      addition, members get access to live biweekly Q&A videoconferences in which they can interact
      with coaches and personalize their experience. The cost of full coaching program is $399 for
      the first 3 months, then $99 per month thereafter.

      Participants, having enrolled in the wellness program, will already, as a part of that study,
      have agreed to have data collected at baseline and yearly thereafter, including BMI, blood
      pressure, resting pulse, lipid panel, hemoglobin A1c, health risk assessment survey,
      absenteeism and health claims data at baseline and yearly thereafter. If not collected within
      60 days, a new set of data will be collected to serve as baseline for this study. This is not
      specific for this study, but is the case for any new program activity that a participant in
      the corporate wellness study begins.

      Specifically for this study the health risk assessment data collection (including lab
      analysis) will also be repeated at 12 weeks. The lab work is accomplished at any MHS lab
      facility, according to current medical system standards.

      Participant health claims data will also be evaluated, beginning with the prior year's data,
      if available from MHS Human Resources, being utilized as a baseline, and followed for the
      subsequent years of the study.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Nonrandomized controlled interventional study
primary purpose: Treatment
masking: None (Open Label)
measure: HbA1c
time frame: up to 20 years
description: glycosylated hemoglobin measured from venous blood
measure: BMI
time frame: up to 20 years
description: Body mass index calculated from height and weight
measure: Healthcare expenditures
time frame: up to 20 years
description: Monetary amount spent for healthcare
measure: Total cholesterol
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: Measured from a lipid panel done on venous blood
measure: Low density lipoprotein cholesterol
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: Calculated from a lipid panel done on venous blood
measure: High density lipoprotein cholesterol
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: Measured from a lipid panel done on venous blood
measure: Triglyceride
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: Measured from a lipid panel done on venous blood
measure: Exercise level
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: Amount of time spent per week in moderate to vigorous physical activity
measure: Dietary Recall
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: Daily or weekly average of foods consumed during the last 7 days
measure: Patient Health Questionnaire
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: mood screening questions; two for anxiety
measure: Patient Health Questionnaire
time frame: baseline, 12 weeks, 1 yearly, then yearly for up to 20 years
description: mood screening questions; two for depression.
arm group label: Mastering Diabetes
arm group type: Experimental
description: Adults (hospital employees, their spouses, and community members) who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen to participate in Mastering Diabetes. They may or may not be receiving additional usual care.
arm group label: Usual care
arm group type: No Intervention
description: Employees and spouses of the hospital system who are participating in the employee wellness program, who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen not to participate in Mastering Diabetes. They may or may not be receiving additional usual care.
intervention type: Behavioral
intervention name: Mastering Diabetes
description: Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.
arm group label: Mastering Diabetes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Drozek, DO
phone: 678-447-2509
email: drozek@ohio.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://pubmed.ncbi.nlm.nih.gov/34366745/
description: Retrospective Evaluation of an Online Diabetes Health Coaching Program: A Pilot Study
responsible party type: Principal Investigator
investigator affiliation: Ohio University
investigator full name: David Drozek
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: Undecided