<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/NCT03805373</url>
  </required_header>
  <id_info>
    <org_study_id>PKE DRS</org_study_id>
    <secondary_id>19PRE34450165</secondary_id>
    <nct_id>NCT03805373</nct_id>
  </id_info>
  <brief_title>Validation of a Diet Risk Screening Tool</brief_title>
  <acronym>DRS</acronym>
  <official_title>Validation of a Diet Risk Screening Tool</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Penn State 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>
      Cardiovascular disease (CVD) is responsible for 1 in 4 deaths in the US annually. Nutrition&#xD;
      is an important part of prevention and management of CVD and other chronic diseases, but only&#xD;
      about 25% of patients with a chronic disease diagnosis (and about 12% of patients without a&#xD;
      chronic disease) receive nutrition counseling from their physician. The investigators plan to&#xD;
      validate a diet questionnaire in preparation for the creation of a diet assessment/&#xD;
      intervention tool to increase rates of nutrition intervention in medical care. The aim of&#xD;
      this project is to test whether the developed questionnaire accurately identifies individuals&#xD;
      at high nutritional risk compared to the Healthy Eating Index- 2015 (HEI-2015) determined by&#xD;
      a validated questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart disease is the leading cause of death in the US. The risk of heart disease increases&#xD;
      with diabetes, overweight/obesity and unhealthy lifestyle behaviors. Despite the well&#xD;
      recognized benefits of a healthy lifestyle in reducing heart disease risk, nutrition is not a&#xD;
      part of routine medical care. Only about 25% of patients with a chronic disease, such as CVD&#xD;
      (and only about 12% of those without a chronic disease), receive nutrition education from&#xD;
      their doctor. Doctors often report a lack of confidence in providing nutrition education, and&#xD;
      a lack of time in the office visit. Doctors need resources to assess diet and discuss&#xD;
      nutrition with patients. This research aims to provide doctors with a diet assessment/&#xD;
      intervention tool to improve rates of nutrition intervention in medical care.&#xD;
&#xD;
      There are few nutrition assessment tools appropriate for use in a medical office visit. The&#xD;
      investigators have created a 9-item questionnaire that doctors can use to quickly assess diet&#xD;
      in the office visit and plan test to it ensure that it measures diet accurately. In this&#xD;
      study, the investigators will test the new questionnaire against an established, validated&#xD;
      tool called a food frequency questionnaire. The investigators will also create talking points&#xD;
      that physicians can use to help their patients make healthy dietary changes. In the future,&#xD;
      the investigators will create a cell phone app based on the questionnaire that can be&#xD;
      accessed quickly in an office visit. The app will provide a risk score and personalized&#xD;
      talking points that can be discussed with the patient or e-mailed to them directly.&#xD;
&#xD;
      An increase of just 1 serving of fruit per day (1 small apple, 1 cup of berries, 1 orange)&#xD;
      could save over 1 million lives per year and reduce heart disease risk dramatically. This&#xD;
      project could help to improve nutrition counseling by physicians during office visits, and&#xD;
      can be expected to reduce heart disease rates and increase quality of life for those living&#xD;
      with heart disease. This is important not only because of the statistics above, but also&#xD;
      because when physicians do discuss healthy lifestyle changes with their patients, patients&#xD;
      are more likely to make changes and improve their cardiovascular health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Healthy Eating Index (HEI-2015) Score</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Assess the agreement between DRS (scored out of 27) and HEI-2015 (scored out of 100 points) calculated from Viocare Food Frequency Questionnaire (FFQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Servings of prepared foods</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS prepared foods=0-3 points, FFQ =0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of breads, rolls, sandwiches</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS breads/rolls/sandwiches=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of salty snacks</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS salty snacks=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of processed meats</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS processed meats=0-3 points, FFQ =0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of sugar-sweetened beverages</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS sugar-sweetened beverages=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of nuts, seeds, nut butters</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS nuts/seeds/nut butters=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of fish or shellfish</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS fish/shellfish=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of non-starchy vegetables</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS non-starchy vegetables=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of fruit</measure>
    <time_frame>Usual intake over the course of 1 week.</time_frame>
    <description>Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS fruit=0-3 points, FFQ=0-10 points).</description>
  </secondary_outcome>
  <enrollment type="Actual">125</enrollment>
  <condition>Nutrition</condition>
  <condition>Diet Modification</condition>
  <condition>Preventive Medicine</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Health Promotion</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet Assessment Survey</intervention_name>
    <description>Participants will complete 2 different diet assessment tools separated by at least 1 week.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults across the United States, ages 35-75, with a computer and Internet access.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults across the United States, ages 35-75, with a computer and Internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any individuals not meeting the study inclusion criteria or not willing to adhere to&#xD;
             the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Penny Kris-Etherton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Pennsylvania State University</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Micha R, Penalvo JL, Cudhea F, Imamura F, Rehm CD, Mozaffarian D. Association Between Dietary Factors and Mortality From Heart Disease, Stroke, and Type 2 Diabetes in the United States. JAMA. 2017 Mar 7;317(9):912-924. doi: 10.1001/jama.2017.0947.</citation>
    <PMID>28267855</PMID>
  </results_reference>
  <results_reference>
    <citation>Greenwood JL, Lin J, Arguello D, Ball T, Shaw JM. Healthy eating vital sign: a new assessment tool for eating behaviors. ISRN Obes. 2012 Jul 22;2012:734682. doi: 10.5402/2012/734682. eCollection 2012.</citation>
    <PMID>24533209</PMID>
  </results_reference>
  <results_reference>
    <citation>Kris-Etherton PM, Akabas SR, Bales CW, Bistrian B, Braun L, Edwards MS, Laur C, Lenders CM, Levy MD, Palmer CA, Pratt CA, Ray S, Rock CL, Saltzman E, Seidner DL, Van Horn L. The need to advance nutrition education in the training of health care professionals and recommended research to evaluate implementation and effectiveness. Am J Clin Nutr. 2014 May;99(5 Suppl):1153S-66S. doi: 10.3945/ajcn.113.073502. Epub 2014 Apr 9.</citation>
    <PMID>24717343</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT03805373
org study id: PKE DRS
secondary id: 19PRE34450165
nct id: NCT03805373
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular disease (CVD) is responsible for 1 in 4 deaths in the US annually. Nutrition
      is an important part of prevention and management of CVD and other chronic diseases, but only
      about 25% of patients with a chronic disease diagnosis (and about 12% of patients without a
      chronic disease) receive nutrition counseling from their physician. The investigators plan to
      validate a diet questionnaire in preparation for the creation of a diet assessment/
      intervention tool to increase rates of nutrition intervention in medical care. The aim of
      this project is to test whether the developed questionnaire accurately identifies individuals
      at high nutritional risk compared to the Healthy Eating Index- 2015 (HEI-2015) determined by
      a validated questionnaire.
Heart disease is the leading cause of death in the US. The risk of heart disease increases
      with diabetes, overweight/obesity and unhealthy lifestyle behaviors. Despite the well
      recognized benefits of a healthy lifestyle in reducing heart disease risk, nutrition is not a
      part of routine medical care. Only about 25% of patients with a chronic disease, such as CVD
      (and only about 12% of those without a chronic disease), receive nutrition education from
      their doctor. Doctors often report a lack of confidence in providing nutrition education, and
      a lack of time in the office visit. Doctors need resources to assess diet and discuss
      nutrition with patients. This research aims to provide doctors with a diet assessment/
      intervention tool to improve rates of nutrition intervention in medical care.

      There are few nutrition assessment tools appropriate for use in a medical office visit. The
      investigators have created a 9-item questionnaire that doctors can use to quickly assess diet
      in the office visit and plan test to it ensure that it measures diet accurately. In this
      study, the investigators will test the new questionnaire against an established, validated
      tool called a food frequency questionnaire. The investigators will also create talking points
      that physicians can use to help their patients make healthy dietary changes. In the future,
      the investigators will create a cell phone app based on the questionnaire that can be
      accessed quickly in an office visit. The app will provide a risk score and personalized
      talking points that can be discussed with the patient or e-mailed to them directly.

      An increase of just 1 serving of fruit per day (1 small apple, 1 cup of berries, 1 orange)
      could save over 1 million lives per year and reduce heart disease risk dramatically. This
      project could help to improve nutrition counseling by physicians during office visits, and
      can be expected to reduce heart disease rates and increase quality of life for those living
      with heart disease. This is important not only because of the statistics above, but also
      because when physicians do discuss healthy lifestyle changes with their patients, patients
      are more likely to make changes and improve their cardiovascular health.
observational model: Cohort
time perspective: Cross-Sectional
measure: Healthy Eating Index (HEI-2015) Score
time frame: Usual intake over the course of 1 week.
description: Assess the agreement between DRS (scored out of 27) and HEI-2015 (scored out of 100 points) calculated from Viocare Food Frequency Questionnaire (FFQ)
measure: Servings of prepared foods
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS prepared foods=0-3 points, FFQ =0-10 points).
measure: Servings of breads, rolls, sandwiches
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS breads/rolls/sandwiches=0-3 points, FFQ=0-10 points).
measure: Servings of salty snacks
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS salty snacks=0-3 points, FFQ=0-10 points).
measure: Servings of processed meats
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS processed meats=0-3 points, FFQ =0-10 points).
measure: Servings of sugar-sweetened beverages
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS sugar-sweetened beverages=0-3 points, FFQ=0-10 points).
measure: Servings of nuts, seeds, nut butters
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS nuts/seeds/nut butters=0-3 points, FFQ=0-10 points).
measure: Servings of fish or shellfish
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS fish/shellfish=0-3 points, FFQ=0-10 points).
measure: Servings of non-starchy vegetables
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS non-starchy vegetables=0-3 points, FFQ=0-10 points).
measure: Servings of fruit
time frame: Usual intake over the course of 1 week.
description: Individual items on the test questionnaire will be validated through comparison to detailed. diet data captured in the VioScreen instrument to determine where the questionnaire can be improved (DRS fruit=0-3 points, FFQ=0-10 points).
intervention type: Other
intervention name: Diet Assessment Survey
description: Participants will complete 2 different diet assessment tools separated by at least 1 week.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
last name: Penny Kris-Etherton, PhD
role: Principal Investigator
affiliation: Penn State University
facility: 
country: United States
citation: Micha R, Penalvo JL, Cudhea F, Imamura F, Rehm CD, Mozaffarian D. Association Between Dietary Factors and Mortality From Heart Disease, Stroke, and Type 2 Diabetes in the United States. JAMA. 2017 Mar 7;317(9):912-924. doi: 10.1001/jama.2017.0947.
PMID: 28267855
citation: Greenwood JL, Lin J, Arguello D, Ball T, Shaw JM. Healthy eating vital sign: a new assessment tool for eating behaviors. ISRN Obes. 2012 Jul 22;2012:734682. doi: 10.5402/2012/734682. eCollection 2012.
PMID: 24533209
citation: Kris-Etherton PM, Akabas SR, Bales CW, Bistrian B, Braun L, Edwards MS, Laur C, Lenders CM, Levy MD, Palmer CA, Pratt CA, Ray S, Rock CL, Saltzman E, Seidner DL, Van Horn L. The need to advance nutrition education in the training of health care professionals and recommended research to evaluate implementation and effectiveness. Am J Clin Nutr. 2014 May;99(5 Suppl):1153S-66S. doi: 10.3945/ajcn.113.073502. Epub 2014 Apr 9.
PMID: 24717343
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No