<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/NCT03025451</url>
  </required_header>
  <id_info>
    <org_study_id>16X44</org_study_id>
    <nct_id>NCT03025451</nct_id>
  </id_info>
  <brief_title>Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database</brief_title>
  <official_title>Retrospective Evaluation of Athens Complete Health Improvement Program (CHIP) Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to&#xD;
      evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household&#xD;
      member participated in the class with them.&#xD;
&#xD;
      Participants had health screens before and after completing the class. The data from the&#xD;
      health screens that will be utilized for comparison will include: body mass index (BMI),&#xD;
      blood pressure, and fasting blood sugar and lipid levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Identified data will be provided to the PI from Live Healthy Appalachia/CHIP on a flash&#xD;
      drive. This data will be password protected by the research team. The data will consist of&#xD;
      two different databases, 1) identifiers with health screen results, 2) identifiers with&#xD;
      demographics (age, gender, household member in class). The researchers need data from both&#xD;
      databases for this study. Each participant has been assigned a unique participant number by&#xD;
      CHIP.&#xD;
&#xD;
      The databases will be combined by the research team, allowing the demographics to be matched&#xD;
      to the biomarkers. The unique CHIP identifier will be maintained as a participant ID, while&#xD;
      all other identifying data will then be deleted from the database.&#xD;
&#xD;
      The data will then be analyzed for relationships by a statistician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Weight</measure>
    <time_frame>4 months</time_frame>
    <description>Weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>4 months</time_frame>
    <description>Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Lipid Profile</measure>
    <time_frame>4 months</time_frame>
    <description>Fasting Lipid Profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Glucose</measure>
    <time_frame>4 months</time_frame>
    <description>Fasting Glucose</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">512</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;
          -  Enrolled in The Complete Health Improvement Program&#xD;
&#xD;
          -  Signed the CHIP Request to Participate consent form, which includes the statement: &quot;I&#xD;
             understand that my test results are confidential but may be used for statistical&#xD;
             analysis and group summaries.&quot;&#xD;
&#xD;
          -  Completed both health screens&#xD;
&#xD;
        Exclusion Criteria: none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Kent LM, Morton DP, Rankin PM, Mitchell BG, Chang E, Diehl H. Gender differences in effectiveness of the Complete Health Improvement Program (CHIP) lifestyle intervention: an Australasian study. Health Promot J Austr. 2014 Dec;25(3):222-9. doi: 10.1071/HE14041.</citation>
    <PMID>25476714</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</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>gender</keyword>
  <keyword>age</keyword>
  <keyword>community support</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/NCT03025451
org study id: 16X44
nct id: NCT03025451
lead sponsor: 
has dmc: No
Data from participants in Athens CHIP classes from May 2011 to present will be analyzed to
      evaluate the differences in outcomes based on: 1) gender, 2) age, 3) whether a household
      member participated in the class with them.

      Participants had health screens before and after completing the class. The data from the
      health screens that will be utilized for comparison will include: body mass index (BMI),
      blood pressure, and fasting blood sugar and lipid levels.
Identified data will be provided to the PI from Live Healthy Appalachia/CHIP on a flash
      drive. This data will be password protected by the research team. The data will consist of
      two different databases, 1) identifiers with health screen results, 2) identifiers with
      demographics (age, gender, household member in class). The researchers need data from both
      databases for this study. Each participant has been assigned a unique participant number by
      CHIP.

      The databases will be combined by the research team, allowing the demographics to be matched
      to the biomarkers. The unique CHIP identifier will be maintained as a participant ID, while
      all other identifying data will then be deleted from the database.

      The data will then be analyzed for relationships by a statistician.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight
time frame: 4 months
description: Weight
measure: Blood Pressure
time frame: 4 months
description: Blood Pressure
measure: Fasting Lipid Profile
time frame: 4 months
description: Fasting Lipid Profile
measure: Fasting Glucose
time frame: 4 months
description: Fasting Glucose
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: N/A
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
citation: Kent LM, Morton DP, Rankin PM, Mitchell BG, Chang E, Diehl H. Gender differences in effectiveness of the Complete Health Improvement Program (CHIP) lifestyle intervention: an Australasian study. Health Promot J Austr. 2014 Dec;25(3):222-9. doi: 10.1071/HE14041.
PMID: 25476714
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