Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study

Lifestyle-related Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03661931
• Other study ID #: BHD-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2018
• Source: Boston Heart Diagnostics
• Contact: Michael Dansinger, MD
• Phone: 617-935-2273
• Email: mdansinger[@]bostonheartdx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lifestyle-related Condition
• Mental Disorders
• Nutrient; Excess

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston Heart Diagnostics	David M. Katz, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Retest reliability for DQPN	A secondary outcome is the test-retest reliability coefficient (tau-equivalent reliability measurement) for the DQPN	6 months