Lifestyle-related ConditionNCT03661931
Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study
A study testing DQPN Validation in people with Lifestyle-related Condition and Nutrient; Excess, run by Boston Heart Diagnostics.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lifestyle-related Condition, Nutrient; Excess
- What is being tested?
- DQPN Validation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
David Katz, MD contact
About this study
Official title: Dietary Quality Photo Navigation: A Preliminary Biomarker Validation Study and Comparison With a Food Frequency Questionnaire
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.
Read the detailed description
The primary aim is to test thee principal hypotheses (n=150):
- 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.
- 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.
- 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
- Lifestyle-related Condition, Nutrient; Excess
- Being tested
- DQPN Validation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DQPN ValidationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: DQPN Validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between DQPN results and FFQ results
The primary outcome is the set of correlation coefficients comparing the DQPN results and the FFQ results
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
Retest reliability for DQPN
A secondary outcome is the test-retest reliability coefficient (tau-equivalent reliability measurement) for the DQPN
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start11 Sep 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle-related ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Heart Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- David M. Katz, M.D.
- Responsible party
- Principal investigator, Michael Dansinger, Boston Heart Diagnostics
- Investigators
- Michael Dansinger, MD, Principal investigator, Boston Heart Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661931
- Sponsor's protocol ID
- BHD-005
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Quality Photo Navigation: A Preliminary Biomarker Validation Study and Comparison With a Food Frequency Questionnaire
- ClinicalTrials.gov ID
- NCT03661931
- Acronym / sponsor ID
- BHD-005
- Conditions
- Lifestyle-related Condition, Nutrient; Excess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boston Heart DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- David M. Katz, M.D.
- Study start
- 11 Sep 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DQPN Validation | Experimental | Diagnostic Test: DQPN ValidationWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DQPN ValidationWe 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. | Diagnostic test | DQPN Validation |
Primary outcome
Correlation between DQPN results and FFQ results
Time frame: 6 months
The primary outcome is the set of correlation coefficients comparing the DQPN results and the FFQ results
4 secondary outcomes
Correlation between DQPN and biomarkers
Time frame: 6 months
Number of minutes spent completing the DQPN and FFQ
Time frame: 6 months
Correlation between FFQ and biomarkers
Time frame: 6 months
Retest reliability for DQPN
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Katz, MD contact
Michael Dansinger, MD principal investigator
Boston Heart Diagnostics
Questions about this trial
What is this clinical trial studying?
A study testing DQPN Validation in people with Lifestyle-related Condition and Nutrient; Excess, run by Boston Heart Diagnostics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Dansinger, MD (617-935-2273, mdansinger@bostonheartdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between DQPN results and FFQ results (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.