Development of a Web-Based Food Frequency Questionnaire and Diet Quality Score for Turkish Adults

January 20, 2025 updated by: Merve GÜNEY COŞKUN, Medipol University

Development of a Web-Based Food Frequency Questionnaire and Diet Quality Score for Turkish Adults: Validity and Reliability

This research aims to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment tools for Turkey. The study involves adapting the UK-based eNutri FFQ to reflect Turkish dietary habits, including revising the food list, capturing portion size photos, and incorporating local food composition data. The revised FFQ will be validated against three 24-hour dietary recalls and tested for reproducibility.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Non-communicable diseases (NCDs), such as cardiovascular diseases, are important global health concerns. Accurate dietary assessment is pivotal in understanding the relationship between food intake and health outcomes. Presently, there is a notable absence of a comprehensive dietary assessment tool tailored for the Turkish population.

Objective: The primary objective of this research is to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment methods.

Design and Proposed Analysis: The first part of the study will involve adapting the UK-based e-Nutri FFQ to reflect dietary habits of Turkish adults (eNutri-Turkey), such as revising the food list, taking portion size photos, and incorporating Turkish food composition data. The revised FFQ delivered online will be validated against three 24-hour recalls by phone (reference method) and the FFQ will be administered twice to assess reproducibility. The study will employ Cronbach's Alpha for internal consistency and the Bland-Altman method for validity. Additionally, inter-rater reliability and reproducibility will be assessed through Cohen's Kappa and ICC analysis, respectively. The eNutri DQS will be adapted in accordance with Turkish dietary guidelines. Following the adaptation, its validity will be assessed using existing Turkish population nutrient data. This analysis will involve retrospectively calculating the DQS and examining its associations with key risk markers of chronic diseases (BMI, blood pressure, blood glucose and cholesterol levels). Additionally, two qualitative studies will be conducted before starting the validation study. Dietitians and nutrition academics from Turkey (n=10) will provide insights on the suitability and effectiveness of eNutri-Turkey through one-to-one interviews. Feedback received will be used to improve the FFQ and DQS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Beykoz
      • İstanbul, Beykoz, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of Turkish adults aged 18-65 years who reside in Turkey.

Description

Inclusion Criteria:

  • Adults aged 18-65 years.
  • No diagnosed medical conditions (e.g., diabetes, heart disease, cancer, gastrointestinal conditions).
  • Not pregnant or lactating.
  • No food allergies or intolerances.
  • Not following a specialized diet (e.g., vegan, weight-loss, sports nutrition regimen; vegetarians are eligible).
  • Not receiving face-to-face nutritional services or dietary advice from a medical professional.
  • Not participating in another nutrition study.
  • Residing in Turkey.

Exclusion Criteria:

  • Individuals with any diagnosed medical conditions.
  • Pregnant or lactating women.
  • Individuals with food allergies or intolerances.
  • Those following a specialized diet (except vegetarians).
  • Participants currently receiving face-to-face nutritional services or dietary advice.
  • Individuals involved in another nutrition study.
  • Individuals residing outside of Turkey.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validity of the web-based FFQ
Time Frame: 14-day period
Assesses the validity of the adapted eNutri FFQ by comparing its results with those from three 24-hour dietary recalls. Validity is evaluated based on nutrient intake measurements.
14-day period
Reproducibility of the web-based FFQ
Time Frame: 14-day period
Measures reproducibility by administering the FFQ twice to participants and analyzing the consistency of the results. Consistency of results; statistical measures will be used for analysis.
14-day period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability of the web-based FFQ
Time Frame: Immediately after the first FFQ administration
Evaluates usability through participant feedback on a scale (e.g., Likert scale) on the clarity and ease of use of the FFQ and portion size images.
Immediately after the first FFQ administration
Usability Comparison of 24-Hour Recall and web-based FFQ
Time Frame: Immediately after the second FFQ administration
Compares dietary intake data obtained from the 24-hour recall method (reference method) with that obtained from the FFQ administered after the second FFQ to assess usability.
Immediately after the second FFQ administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-10840098-772.02-6576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Individual Participant Data (IPD) sharing plan does not include making anonymized data available to other researchers. Instead, data access will be provided only through secure platforms to researchers with approved proposals, ensuring adherence to confidentiality and ethical standards. The data will be shared through publication, with clear terms outlined to safeguard participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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