<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/NCT02977884</url>
  </required_header>
  <id_info>
    <org_study_id>12X81</org_study_id>
    <nct_id>NCT02977884</nct_id>
  </id_info>
  <brief_title>Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project</brief_title>
  <official_title>Complete Health Improvement Program (CHIP) Risk Reduction/Claims Evaluation Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Touro University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project proposes to provide the Complete Health Improvement Program (CHIP) initially up&#xD;
      to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members)&#xD;
      with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension,&#xD;
      atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve&#xD;
      self-management and the consequences of biometric factors that can be modified by lifestyle&#xD;
      changes. The CHIP program is an educationally based, lifestyle intervention program that aims&#xD;
      to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators&#xD;
      expect that participants following the programs guidelines will lower their body mass index,&#xD;
      cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent&#xD;
      chronic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In our Western culture, lifestyle changes focusing on diet, exercise and tobacco could&#xD;
      prevent about 40% of all cancer deaths, and 82% of cardiac deaths, in the U.S. It is&#xD;
      estimated that 71% of colon cancers, 70% of strokes, and 91% of diabetic cases could be&#xD;
      avoided by living a healthy lifestyle. These health problems add a tremendous burden to our&#xD;
      healthcare budget, and to the loss of productivity of our society. In 2007, it was estimated&#xD;
      that 2.3 trillion dollars was spent on healthcare in the U.S., $7,600 for each individual.&#xD;
      Expectations are that without dramatic change, this cost will continue to increase to&#xD;
      unsustainable levels.&#xD;
&#xD;
      The Complete Health Improvement Program (CHIP) is a community based lifestyle medicine&#xD;
      program with proven effectiveness in addressing these problems.&#xD;
&#xD;
      The project proposes to provide the Complete Health Improvement Program (CHIP) to adult&#xD;
      (non-pregnant) Ohio University employees (and/ or their adult family members) with with&#xD;
      diabetes / prediabetes, obesity / overweight, hypertension / prehypertension, atherosclerotic&#xD;
      cardiovascular disease, or dyslipidemia in an effort to improve self-management and the&#xD;
      consequences of biometric factors that can be modified by lifestyle changes. The CHIP program&#xD;
      is an educationally based, lifestyle intervention program that aims to reduce healthcare&#xD;
      cost, absenteeism, and increase employee productivity. The investigators expect that&#xD;
      participants following the programs guidelines will lower their body mass index, cholesterol,&#xD;
      reduce blood pressure and blood glucose levels, and therefore help to prevent chronic&#xD;
      disease.&#xD;
&#xD;
      Ohio University Human Resources (HR) will provide research participants with scholarships to&#xD;
      attend the CHIP program.&#xD;
&#xD;
      One aim of the project is to compare biometrics factors (weight, cholesterol, LDL, HDL,&#xD;
      triglycerides, blood pressure, and fasting blood glucose, HgA1c) of participants before and&#xD;
      after completion of the program (program completion defined as those who attended at least 14&#xD;
      of 16 CHIP classes, or 15 of the 18 new CHIP+ classes).&#xD;
&#xD;
      A second aim is to compare this groups health claims (health care utilization office visits,&#xD;
      emergency room visits, hospitalizations, medication costs) with a control groups data (OU&#xD;
      employees who have diabetes / prediabetes, obesity / overweight, hypertension /&#xD;
      prehypertension, atherosclerotic cardiovascular disease, or dyslipidemia and do not&#xD;
      participate in CHIP program).&#xD;
&#xD;
      A third aim is to compare the treatment groups absenteeism due to illness data with that of&#xD;
      the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">April 1, 2023</completion_date>
  <primary_completion_date type="Actual">April 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healthcare expenses</measure>
    <time_frame>2.5 years</time_frame>
    <description>Healthcare costs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Glucose</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Lipid Profile</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absenteeism: Sick days on record at Ohio University Human Resources</measure>
    <time_frame>2.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">389</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Hypertension</condition>
  <condition>Dyslipidemias</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>The Complete Health Improvement Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in The Complete Health Improvement Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Complete Health Improvement Program</intervention_name>
    <description>CHIP focuses on food, diet, activity, exercise, stress management, by viewing videos, cooking demonstrations, discussion, and exercise. Intervention nurtures intelligent self-care through enhanced understanding of the epidemiology, etiology, and risk factors associated with chronic lifestyle related diseases. The primary focus is the consumption of plant-based whole foods, such as fresh fruits, vegetables, whole grains, legumes, and nuts. The goal was to keep dietary fat below 20% of total calories, daily intake of added sugar below 10 tsps, sodium below 2,000 mg, and cholesterol below 50 mg. High fiber food intake (&gt;35 g/day) is encouraged, and flexibility exercises, a daily walk of 30 minutes or 10,000 steps and daily use of stress management techniques.</description>
    <arm_group_label>The Complete Health Improvement Program</arm_group_label>
    <other_name>CHIP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, non-pregnant OU employees or adult families who are covered by Ohio University&#xD;
             insurance and are participating in the Athens Complete Health Improvement Program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Under the age of 18&#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>David S Drozek, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio University</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rankin P, Morton DP, Diehl H, Gobble J, Morey P, Chang E. Effectiveness of a volunteer-delivered lifestyle modification program for reducing cardiovascular disease risk factors. Am J Cardiol. 2012 Jan 1;109(1):82-6. doi: 10.1016/j.amjcard.2011.07.069. Epub 2011 Sep 23.</citation>
    <PMID>21944675</PMID>
  </reference>
  <reference>
    <citation>Leibold C, Shubrook JH, Nakazawa M, Drozek D. Effectiveness of the Complete Health Improvement Program in Reducing Risk Factors for Cardiovascular Disease in an Appalachian Population. J Am Osteopath Assoc. 2016 Feb;116(2):84-91. doi: 10.7556/jaoa.2016.020.</citation>
    <PMID>26830523</PMID>
  </reference>
  <reference>
    <citation>Vogelgesang J, Drozek D, Nakazawa M, Shubrook JH. Payer source influence on effectiveness of lifestyle medicine programs. Am J Manag Care. 2015 Sep 1;21(9):e503-8.</citation>
    <PMID>26618437</PMID>
  </reference>
  <reference>
    <citation>Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16.</citation>
    <PMID>24527219</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>nutrition</keyword>
  <keyword>exercise</keyword>
  <keyword>stress</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>diabetes</keyword>
  <keyword>hypertension</keyword>
  <keyword>dyslipidemia</keyword>
  <keyword>cholesterol</keyword>
  <keyword>overweight</keyword>
  <keyword>obesity</keyword>
  <keyword>lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Dyslipidemias</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/NCT02977884
org study id: 12X81
nct id: NCT02977884
lead sponsor: 
collaborator: 
has dmc: No
The project proposes to provide the Complete Health Improvement Program (CHIP) initially up
      to 25 adult (non-pregnant) Ohio University employees (and/ or their adult family members)
      with with diabetes / prediabetes, obesity / overweight, hypertension / prehypertension,
      atherosclerotic cardiovascular disease, or dyslipidemia in an effort to improve
      self-management and the consequences of biometric factors that can be modified by lifestyle
      changes. The CHIP program is an educationally based, lifestyle intervention program that aims
      to reduce healthcare cost, absenteeism, and increase employee productivity. The investigators
      expect that participants following the programs guidelines will lower their body mass index,
      cholesterol, reduce blood pressure and blood glucose levels, and therefore help to prevent
      chronic disease.
In our Western culture, lifestyle changes focusing on diet, exercise and tobacco could
      prevent about 40% of all cancer deaths, and 82% of cardiac deaths, in the U.S. It is
      estimated that 71% of colon cancers, 70% of strokes, and 91% of diabetic cases could be
      avoided by living a healthy lifestyle. These health problems add a tremendous burden to our
      healthcare budget, and to the loss of productivity of our society. In 2007, it was estimated
      that 2.3 trillion dollars was spent on healthcare in the U.S., $7,600 for each individual.
      Expectations are that without dramatic change, this cost will continue to increase to
      unsustainable levels.

      The Complete Health Improvement Program (CHIP) is a community based lifestyle medicine
      program with proven effectiveness in addressing these problems.

      The project proposes to provide the Complete Health Improvement Program (CHIP) to adult
      (non-pregnant) Ohio University employees (and/ or their adult family members) with with
      diabetes / prediabetes, obesity / overweight, hypertension / prehypertension, atherosclerotic
      cardiovascular disease, or dyslipidemia in an effort to improve self-management and the
      consequences of biometric factors that can be modified by lifestyle changes. The CHIP program
      is an educationally based, lifestyle intervention program that aims to reduce healthcare
      cost, absenteeism, and increase employee productivity. The investigators expect that
      participants following the programs guidelines will lower their body mass index, cholesterol,
      reduce blood pressure and blood glucose levels, and therefore help to prevent chronic
      disease.

      Ohio University Human Resources (HR) will provide research participants with scholarships to
      attend the CHIP program.

      One aim of the project is to compare biometrics factors (weight, cholesterol, LDL, HDL,
      triglycerides, blood pressure, and fasting blood glucose, HgA1c) of participants before and
      after completion of the program (program completion defined as those who attended at least 14
      of 16 CHIP classes, or 15 of the 18 new CHIP+ classes).

      A second aim is to compare this groups health claims (health care utilization office visits,
      emergency room visits, hospitalizations, medication costs) with a control groups data (OU
      employees who have diabetes / prediabetes, obesity / overweight, hypertension /
      prehypertension, atherosclerotic cardiovascular disease, or dyslipidemia and do not
      participate in CHIP program).

      A third aim is to compare the treatment groups absenteeism due to illness data with that of
      the control group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Healthcare expenses
time frame: 2.5 years
description: Healthcare costs
measure: Weight
time frame: 3 months
measure: Fasting Glucose
time frame: 3 months
measure: Fasting Lipid Profile
time frame: 3 months
measure: Absenteeism: Sick days on record at Ohio University Human Resources
time frame: 2.5 years
arm group label: The Complete Health Improvement Program
arm group type: Experimental
description: Participants in The Complete Health Improvement Program
intervention type: Behavioral
intervention name: The Complete Health Improvement Program
description: CHIP focuses on food, diet, activity, exercise, stress management, by viewing videos, cooking demonstrations, discussion, and exercise. Intervention nurtures intelligent self-care through enhanced understanding of the epidemiology, etiology, and risk factors associated with chronic lifestyle related diseases. The primary focus is the consumption of plant-based whole foods, such as fresh fruits, vegetables, whole grains, legumes, and nuts. The goal was to keep dietary fat below 20% of total calories, daily intake of added sugar below 10 tsps, sodium below 2,000 mg, and cholesterol below 50 mg. High fiber food intake (>35 g/day) is encouraged, and flexibility exercises, a daily walk of 30 minutes or 10,000 steps and daily use of stress management techniques.
arm group label: The Complete Health Improvement Program
other name: CHIP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David S Drozek, DO
role: Principal Investigator
affiliation: Ohio University
facility: 
country: United States
citation: Rankin P, Morton DP, Diehl H, Gobble J, Morey P, Chang E. Effectiveness of a volunteer-delivered lifestyle modification program for reducing cardiovascular disease risk factors. Am J Cardiol. 2012 Jan 1;109(1):82-6. doi: 10.1016/j.amjcard.2011.07.069. Epub 2011 Sep 23.
PMID: 21944675
citation: Leibold C, Shubrook JH, Nakazawa M, Drozek D. Effectiveness of the Complete Health Improvement Program in Reducing Risk Factors for Cardiovascular Disease in an Appalachian Population. J Am Osteopath Assoc. 2016 Feb;116(2):84-91. doi: 10.7556/jaoa.2016.020.
PMID: 26830523
citation: Vogelgesang J, Drozek D, Nakazawa M, Shubrook JH. Payer source influence on effectiveness of lifestyle medicine programs. Am J Manag Care. 2015 Sep 1;21(9):e503-8.
PMID: 26618437
citation: Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16.
PMID: 24527219
responsible party type: Principal Investigator
investigator affiliation: Ohio University
investigator full name: David Drozek
investigator title: Assistant Professor
mesh term: Hypertension
mesh term: Cardiovascular Diseases
mesh term: Overweight
mesh term: Dyslipidemias
sharing ipd: No