Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study

NCT ID: NCT03661931

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2019-06-01

Brief Summary

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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

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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.

Conditions

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Lifestyle-related Condition Nutrient; Excess

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DQPN Validation

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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David M. Katz, M.D.

INDIV

Sponsor Role collaborator

Boston Heart Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Michael Dansinger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Dansinger, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Heart Diagnostics

Central Contacts

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Michael Dansinger, MD

Role: CONTACT

617-935-2273

David Katz, MD

Role: CONTACT

Other Identifiers

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BHD-005

Identifier Type: -

Identifier Source: org_study_id

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