Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study

NCT03661931 | Unknown

• 1 other identifier: BHD-005
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lifestyle-related Condition; Nutrient; Excess

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between DQPN and biomarkers

  6 months

• Number of minutes spent completing the DQPN and FFQ

  6 months

• Correlation between FFQ and biomarkers

  6 months

• Retest reliability for DQPN

  6 months

Study Arms (1)

DQPN Validation

EXPERIMENTAL

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

Interventions

DQPN Validation DIAGNOSTIC_TEST

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.

DQPN Validation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Heart Diagnostics: lead
• David M. Katz, M.D.: collaborator

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Michael Dansinger, MD

  Boston Heart Diagnostics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dansinger, MD

CONTACT

617-935-2273; mdansinger@bostonheartdx.com

David Katz, MD

CONTACT

dkatz@dqpn.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: September 11, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share