Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of a Diet Risk Screening Tool (DRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03805373
Recruitment Status : Active, not recruiting
First Posted : January 15, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Penny, Penn State University

Brief Summary:
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.

Condition or disease Intervention/treatment
Nutrition Diet Modification Preventive Medicine Cardiovascular Diseases Health Promotion Other: Diet Assessment Survey

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of a Diet Risk Screening Tool
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Other: Diet Assessment Survey
    Participants will complete 2 different diet assessment tools separated by at least 1 week.


Primary Outcome Measures :
  1. Healthy Eating Index (HEI-2015) Score [ Time Frame: Usual intake over the course of 1 week. ]
    Assess the agreement between DRS (scored out of 27) and HEI-2015 (scored out of 100 points) calculated from Viocare Food Frequency Questionnaire (FFQ)


Secondary Outcome Measures :
  1. Servings of prepared foods [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  2. Servings of breads, rolls, sandwiches [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  3. Servings of salty snacks [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  4. Servings of processed meats [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  5. Servings of sugar-sweetened beverages [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  6. Servings of nuts, seeds, nut butters [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  7. Servings of fish or shellfish [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  8. Servings of non-starchy vegetables [ Time Frame: Usual intake over the course of 1 week. ]
    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).

  9. Servings of fruit [ Time Frame: Usual intake over the course of 1 week. ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults across the United States, ages 35-75, with a computer and Internet access.
Criteria

Inclusion Criteria:

  • Adults across the United States, ages 35-75, with a computer and Internet access

Exclusion Criteria:

  • Any individuals not meeting the study inclusion criteria or not willing to adhere to the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805373


Locations
Layout table for location information
United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
American Heart Association
Investigators
Layout table for investigator information
Principal Investigator: Penny Kris-Etherton, PhD Penn State University
Publications of Results:
Layout table for additonal information
Responsible Party: Penny, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03805373    
Other Study ID Numbers: PKE DRS
19PRE34450165 ( Other Grant/Funding Number: American Heart Association )
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases