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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04779411




Registration number
NCT04779411
Ethics application status
Date submitted
26/02/2021
Date registered
3/03/2021

Titles & IDs
Public title
Online Validation of Dietary Intake Food Frequency Questionnaire Over Four Weeks, and Electronic Device Use Questionnaire Over Eight Weeks.
Scientific title
Validation of a Lutein and Zeaxanthin Food Frequency Questionnaire, and an Electronic Device Use Questionnaire.
Secondary ID [1] 0 0
FFQEDUQ20V1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lutein and Zeaxanthin Dietary Intake 0 0
Age Related Macular Degeneration 0 0
Blue Light Exposure 0 0
Electronic Device Use 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Weekly Food Frequency Questionnaire
Other interventions - Monthly Food Frequency Questionnaire
Other interventions - 24-Hour Diet Recall
Other interventions - Electronic Device Use Questionnaire
Other interventions - 24-Hour Electronic Device Use Diary

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.

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 interventions: 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 interventions: 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 interventions: 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.

Other interventions: 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 interventions: 24-Hour Electronic Device Use Diary
Participants asked to record their electronic device use in hours and minutes over 24 hours.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily Intake of lutein and zeaxanthin
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Daily hours of electronic device use.
Timepoint [2] 0 0
8 weeks

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Visual, hearing, or physical impairment that may prevent from completing investigations.
* No English literacy.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland - St Lucia
Recruitment postcode(s) [1] 0 0
4067 - St Lucia

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04779411