Online Validation of Dietary Intake Food Frequency Questionnaire Over Four Weeks, and Electronic Device Use Questionnaire Over Eight Weeks.

May 18, 2023 updated by: The University of Queensland

Validation of a Lutein and Zeaxanthin Food Frequency Questionnaire, and an Electronic Device Use Questionnaire.

Tools to investigate dietary lutein and zeaxanthin (L/Z) intake and electronic device (ED) use are important to progress research that investigates the role of ED blue light (BL) exposure, and dietary L/Z intake on macular health. This project aims to validate two questionnaires developed by our research group: The L/Z FFQ, and the Electronic Device Use Questionnaire (EDUQ). The L/Z FFQ aims to investigate dietary intake of L/Z over the prior week or month. The EDUQ aims to investigate usual hours and behaviours surrounding ED use over the prior three months.

This aims of this project are to:

  1. Validate a L/Z FFQ recalling over a weekly and monthly timeframe against multiple 24-hour diet recalls over four weeks.
  2. Validate the EDUQ against multiple 24-hour ED use diaries over eight weeks. A cohort of 100 adults will be invited to participate to validate the FFQ and EDUQ. Participants will be offered to choose to participate in one or both the questionnaire validations (L/Z FFQ and EDUQ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

L/Z FFQ Validation The validation procedure will span over four weeks, consisting of administering the L/Z FFQ and 24-hour diet recalls at multiple timepoints. Timepoints for the eight 24-hour diet recalls will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on week days.

  • The weekly L/Z FFQ will be completed at the conclusion of each of the four weeks.
  • The monthly L/Z FFQ will be completed at baseline and at the conclusion of week four.

Participants will indicate their consent to participate on Checkbox® by proceeding to the complete the questionnaires.

  1. Demographic information: at the beginning of the first investigation (monthly L/Z FFQ) participants will be asked to report their weight, height, age, gender, highest level of education, occupational status (employed or unemployed), post-code and country of residence, usual hours of physical activity per week, how they heard about the study, and whether they are actively trying to gain or lose weight. Personal information is to be collected to qualify the characteristics of the population in which the tool is being validated. Data collected via Checkbox ®.
  2. L/Z FFQ: The weekly L/Z FFQ is a 91-item questionnaire that takes approximately 20 minutes to complete, and investigates the frequency of intake of listed foods or supplements over the prior seven days. The monthly L/Z FFQ contains the same 91 items, takes approximately 30 minutes to complete, and investigates the frequency of intake of listed foods or supplements over the prior month. In addition, the monthly L/Z FFQ contains four qualitative questions that investigate change in usual dietary intake over the last one to ten years. Questionnaire data collected via Checkbox®.
  3. 24-hour diet recall: the diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours (20). The ASA24® is supported by the National Institutes of Health (NIH) in the United States (US) with national variants and as a US government entity not within the EU-US Data Privacy Shield for legal reasons. Therefore, explicit consent for use of the ASA24® tool will be sought from participants. For further information on the tool: https://epi.grants.cancer.gov/asa24/.

EDUQ Validation

The validation procedure will occur over eight weeks consisting of administering eight 24-hour diary of ED use (24-hour ED use diary) and the EDUQ at three time points. The time points for the eight 24-hour ED use diaries will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on weekdays. The EDUQ will be completed at baseline and at the conclusion of weeks four and eight. Upon consenting to participate on the Checkbox® by proceeding to the questionnaires, participants will be instructed to fill out:

  1. The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday (questionnaire adapted from Williams et al. (2019) (21). Personal information collected as part of this questionnaire is to qualify the characteristics of the population in which the tool is being validated. Data collected via Checkbox®.
  2. 24-hour ED use diary: Participants will be asked to record their ED use in hours and minutes over 24 hours. Data collected via Checkbox®.

Study Type

Observational

Enrollment (Actual)

183

Contacts and Locations

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

Study Locations

  • Australia
    • Queensland
      • St Lucia, Queensland, Australia, 4067
        • University of Queensland

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Generally healthy male and female adults from Australia or the United Kingdom.

Description

Inclusion Criteria:

  • Healthy males and females 18 years and over.
  • Access to an ED such as a computer, phone, or tablet, and internet to complete investigations.

Exclusion Criteria:

  • Visual, hearing, or physical impairment that may prevent from completing investigations.
  • No English literacy.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Food Frequency Questionnaire Validation Group

The validation procedure will span over four weeks, consisting of administering the Lutein and Zeaxanthin Food Frequency Questionnaire (FFQ L/Z) and 24-hour diet recalls at multiple timepoints. Timepoints for the eight 24-hour diet recalls will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on week days.

  • The weekly L/Z FFQ will be completed at the conclusion of each of the four weeks.
  • The monthly L/Z FFQ will be completed at baseline and at the conclusion of week four.
Other: Weekly Food Frequency Questionnaire
A purpose designed 91-item questionnaire to measure frequency of consumption of a selection of L/Z containing foods over the prior 7 days.
Other: Monthly Food Frequency Questionnaire
A purpose designed 95-item questionnaire completed at visit 1 to measure frequency of consumption of a selection of L/Z containing foods over the prior month.
Other: 24-Hour Diet Recall
the diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours.
Electronic Device Use Questionnaire Validation Group
The validation procedure will occur over eight weeks consisting of administering eight 24-hour diary of electronic device use (24-hour ED use diary) and the Electronic Device Use Questionnaire (EDUQ) at three time points. The time points for the eight 24-hour ED use diaries will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on weekdays. The EDUQ will be completed at baseline and at the conclusion of weeks four and eight.
Other: Electronic Device Use Questionnaire
1. The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday.
Other: 24-Hour Electronic Device Use Diary
Participants asked to record their electronic device use in hours and minutes over 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Intake of lutein and zeaxanthin
Time Frame: 4 weeks
Calculation from each dietary intake tool what the daily milligrams of lutein and zeaxanthin intake is.
4 weeks
Daily hours of electronic device use.
Time Frame: 8 weeks
Calculation from the two device use recording tools what the daily hours of electronic device use is for each participant.
8 weeks

Collaborators and Investigators

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

Sponsor

The University of Queensland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

August 18, 2020

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFQEDUQ20V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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