Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study

Not Applicable

• Conditions: Nutrient; Excess; Lifestyle-related Condition

• Registration Number: NCT03661931
• Lead Sponsor: Boston Heart Diagnostics

Brief Summary

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.

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 Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Last Update Submitted: 2018-09-05
• Study First Posted: 2018-09-07
• Last Update Posted: 2018-09-07
• Study Start: 2018-09-11
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation between DQPN results and FFQ results	6 months	The primary outcome is the set of correlation coefficients comparing the DQPN results and the FFQ results

Secondary Outcome Measures

Name	Time	Method
Retest reliability for DQPN	6 months	A secondary outcome is the test-retest reliability coefficient (tau-equivalent reliability measurement) for the DQPN
Correlation between DQPN and biomarkers	6 months	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
Number of minutes spent completing the DQPN and FFQ	6 months	A secondary outcome is the median number of minutes spent completing the DQPN and the FFQ will be compared
Correlation between FFQ and biomarkers	6 months	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.