Clinical trial NCT03805373: Validation of a Diet Risk Screening Tool
Official title: Validation of a Diet Risk Screening Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition
Diet Modification
Preventive Medicine
Cardiovascular Diseases
Health Promotion
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-01-15
Enrollment: 125
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults across the United States, ages 35-75, with a computer and Internet access.

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.

Eligibility 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

Primary outcomes:
measure: Healthy Eating Index (HEI-2015) Score
timeFrame: Usual intake over the course of 1 week.
Secondary outcomes:
measure: Servings of prepared foods
timeFrame: Usual intake over the course of 1 week.
measure: Servings of breads, rolls, sandwiches
timeFrame: Usual intake over the course of 1 week.
measure: Servings of salty snacks
timeFrame: Usual intake over the course of 1 week.
measure: Servings of processed meats
timeFrame: Usual intake over the course of 1 week.
measure: Servings of sugar-sweetened beverages
timeFrame: Usual intake over the course of 1 week.
measure: Servings of nuts, seeds, nut butters
timeFrame: Usual intake over the course of 1 week.
measure: Servings of fish or shellfish
timeFrame: Usual intake over the course of 1 week.
measure: Servings of non-starchy vegetables
timeFrame: Usual intake over the course of 1 week.
measure: Servings of fruit
timeFrame: Usual intake over the course of 1 week.
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.