Validation of a Diet Risk Screening Tool

NCT ID: NCT03805373

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Diet Assessment Survey

Participants will complete 2 different diet assessment tools separated by at least 1 week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny Kris-Etherton, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 28267855 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24533209 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24717343 (View on PubMed)

Johnston EA, Petersen KS, Beasley JM, Krussig T, Mitchell DC, Van Horn LV, Weiss R, Kris-Etherton PM. Relative validity and reliability of a diet risk score (DRS) for clinical practice. BMJ Nutr Prev Health. 2020 Oct 8;3(2):263-269. doi: 10.1136/bmjnph-2020-000134. eCollection 2020 Dec.

Reference Type: DERIVED

PMID: 33521537 (View on PubMed)

Other Identifiers

19PRE34450165

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PKE DRS

Identifier Type: -

Identifier Source: org_study_id