Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study

Dietary Quality Photo Navigation: A Preliminary Biomarker Validation Study and Comparison With a Food Frequency Questionnaire

The purpose of this research project is to conduct a preliminary validation study of the Diet Quality Photo Navigation (DQPN) method of dietary intake assessment. In 150 adults, dietary intake as estimated by the DQPN will be compared to dietary intake as estimated by a food frequency questionnaire (FFQ) and with blood levels of fatty acids, folic acid, and beta-carotene as biomarkers of dietary intake.

Study Overview

• Status: Unknown
• Conditions: Lifestyle-related Condition; Nutrient; Excess
• Intervention / Treatment: Diagnostic test: DQPN Validation

Detailed Description

The primary aim is to test thee principal hypotheses (n=150):

1. There will be statistically significant correlations between blood levels of fatty acids/folate/beta-carotene and their corresponding levels of dietary intake as estimated by the DQPN.
2. There will be statistically significant correlations between the DQPN and FFQ methods of dietary intake assessment. This includes individual dietary components as well as overall dietary quality and disease risk assessments.
3. User experience surveys will demonstrate that the DQPN can be completed more quickly and more enjoyably than the FFQ.

In addition, investigators will assess whether blood levels of fatty acids/folate/beta-carotene are similarly associated with the DQPN method and the FFQ method, and will measure the test-retest reliability of the DQPN method.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Dansinger, MD; Phone Number: 617-935-2273; Email: mdansinger@bostonheartdx.com
• Study Contact Backup: Name: David Katz, MD; Email: dkatz@dqpn.io

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical provider has ordered fasting Boston Heart Fatty Acid Balance and participation in the Boston Heart Lifestyle Program as part of clinical practice.
• Willing to fill out Food Frequency Questionnaire
• Willing to complete DQPN Diet IDTM (on-line), and to repeat that 1 week later
• Willing to complete user experience surveys about each dietary assessment method

Exclusion Criteria:

• Taking fatty acid or vitamin supplements (such as fish oil capsules, or multivitamin tablets)
• Following a diet outside the capabilities of the DQPN cannot be included in this study. The vast majority of eating styles are within the assessment capabilities of the DQPN (Standard American, Low-fat, Mediterranean, Pescatarian, Flexitarian, Low-carb, DASH, AHA, TLC, MIND, Vegetarian, Vegan, Paleo, Southern).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DQPN Validation; We are planning to recruit 150 individuals who are patients in the Boston Heart Lifestyle Program and are already having fatty acids measured as part of clinical care, and ask them to complete the DQPN, FFQ, and a User Experience Questionnaire for each dietary assessment method.	Diagnostic test: DQPN Validation; We are planning to recruit 150 individuals who are patients in the Boston Heart Lifestyle Program and are already having fatty acids measured as part of clinical care, and ask them to complete the DQPN, FFQ, and a brief User Experience Questionnaire for each dietary assessment method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between DQPN results and FFQ results	The primary outcome is the set of correlation coefficients comparing the DQPN results and the FFQ results	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between DQPN and biomarkers	A secondary outcome is the set of correlation coefficients comparing the DQPN results and the corresponding blood levels of fatty acids, folic acid, and beta-carotene	6 months
Number of minutes spent completing the DQPN and FFQ	A secondary outcome is the median number of minutes spent completing the DQPN and the FFQ will be compared	6 months
Correlation between FFQ and biomarkers	A secondary outcome is the set of correlation coefficients comparing the FFQ results and the corresponding blood levels of fatty acids, folic acid, and beta-carotene.	6 months
Retest reliability for DQPN	A secondary outcome is the test-retest reliability coefficient (tau-equivalent reliability measurement) for the DQPN	6 months

Collaborators and Investigators

• Sponsor: Boston Heart Diagnostics
• Collaborators: David M. Katz, M.D.
• Investigators: Principal Investigator: Michael Dansinger, MD, Boston Heart Diagnostics

Study record dates

Study Major Dates

• Study Start (Anticipated): September 11, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BHD-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No