Clinical trial NCT03661931: Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study
Official title: Dietary Quality Photo Navigation: A Preliminary Biomarker Validation Study and Comparison With a Food Frequency Questionnaire
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lifestyle-related Condition
Nutrient; Excess
Lead sponsor: Boston Heart Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: David M. Katz, M.D.
First posted: 2018-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Correlation between DQPN results and FFQ results
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between DQPN and biomarkers
timeFrame: 6 months
measure: Number of minutes spent completing the DQPN and FFQ
timeFrame: 6 months
measure: Correlation between FFQ and biomarkers
timeFrame: 6 months
measure: Retest reliability for DQPN
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston Heart Diagnostics
name: Michael Dansinger, MD
role: PRINCIPAL_INVESTIGATOR
References: