Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03661931
Other study ID # BHD-005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT01323283 - Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children N/A
Completed NCT03430141 - A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer N/A
Completed NCT03553173 - So-Lo-Mo Intervention Applied to the Smoking Cessation Process N/A
Completed NCT02753491 - The Effect of Motivational Short Interview Model in Type 2 Diabetic Patient in Primary Care in TURKEY N/A
Recruiting NCT02999503 - Attention Deficit Hyperactivity Disorder: Nutrition and Environment N/A
Active, not recruiting NCT02428582 - Covered Stents Versus Bare-Metal Stents N/A
Completed NCT06158191 - Long-term Benefits of Abdominal Fat Loss in Abdominally Obese Dyslipidemic Patients (SYNERGIE Study) N/A
Active, not recruiting NCT03146156 - Lifestyle Intervention in Preparation for Pregnancy (LIPP) N/A
Not yet recruiting NCT05770362 - Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays
Recruiting NCT05654337 - Obesity Pathway Intervention Among Overweight and Obese Adults at Primary Care Centers in Hail, Saudi Arabia N/A
Recruiting NCT06425042 - Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity N/A
Active, not recruiting NCT04827615 - Evaluation of the Ambuja Cement Foundation Noncommunicable Disease Program in Bathinda District of Punjab, India N/A
Completed NCT03115645 - Evaluation of the Dynamic Work Intervention for Office Workers to Reduce Sedentary Behaviour N/A
Completed NCT04683588 - The Effect of Coaching Strategy on Some Patient Outcomes After Total Knee Arthroplasty Surgery N/A
Recruiting NCT05999136 - Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds N/A
Completed NCT02832453 - Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial N/A
Active, not recruiting NCT04488289 - The Föllinge Hypertension and Lifestyle Study N/A
Completed NCT04710108 - Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women N/A
Not yet recruiting NCT06309342 - Prevention of Lifestyle-related Disorders Based on Functional Examinations N/A