Validation of a Diet Risk Screening Tool

Cardiovascular Diseases Clinical Trial

— DRS  

Official title:

Validation of a Diet Risk Screening Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805373
• Other study ID #: PKE DRS
• Secondary ID: 19PRE34450165
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diet Modification
• Health Promotion
• Nutrition
• Preventive Medicine

Intervention

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

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 profession — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthy Eating Index (HEI-2015) Score	Assess the agreement between DRS (scored out of 27) and HEI-2015 (scored out of 100 points) calculated from Viocare Food Frequency Questionnaire (FFQ)	Usual intake over the course of 1 week.
Secondary	Servings of prepared foods	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).	Usual intake over the course of 1 week.
Secondary	Servings of breads, rolls, sandwiches	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).	Usual intake over the course of 1 week.
Secondary	Servings of salty snacks	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).	Usual intake over the course of 1 week.
Secondary	Servings of processed meats	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).	Usual intake over the course of 1 week.
Secondary	Servings of sugar-sweetened beverages	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).	Usual intake over the course of 1 week.
Secondary	Servings of nuts, seeds, nut butters	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).	Usual intake over the course of 1 week.
Secondary	Servings of fish or shellfish	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).	Usual intake over the course of 1 week.
Secondary	Servings of non-starchy vegetables	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).	Usual intake over the course of 1 week.
Secondary	Servings of fruit	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).	Usual intake over the course of 1 week.