NCT03805373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

December 19, 2018

Last Update Submit

August 15, 2023

Conditions

NutritionDiet ModificationPreventive MedicineCardiovascular DiseasesHealth Promotion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Servings of prepared foods

    Usual intake over the course of 1 week.

  • Servings of breads, rolls, sandwiches

    Usual intake over the course of 1 week.

  • Servings of salty snacks

    Usual intake over the course of 1 week.

  • Servings of processed meats

    Usual intake over the course of 1 week.

  • Servings of sugar-sweetened beverages

    Usual intake over the course of 1 week.

  • +4 more secondary outcomes

Interventions

Diet Assessment SurveyOTHER

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

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (4)

  • 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: 28267855RESULT

  • 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: 24533209RESULT

  • 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: 24717343RESULT

  • 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.

    PMID: 33521537DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Penny Kris-Etherton, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

January 15, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)