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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
Date last updated
22/05/2023

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
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).
Trial website
https://clinicaltrials.gov/study/NCT04779411
Trial related presentations / publications
Keel S, Xie J, Foreman J, van Wijngaarden P, Taylor HR, Dirani M. Prevalence of Age-Related Macular Degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. 2017 Nov 1;135(11):1242-1249. doi: 10.1001/jamaophthalmol.2017.4182.
Bernstein PS, Li B, Vachali PP, Gorusupudi A, Shyam R, Henriksen BS, Nolan JM. Lutein, zeaxanthin, and meso-zeaxanthin: The basic and clinical science underlying carotenoid-based nutritional interventions against ocular disease. Prog Retin Eye Res. 2016 Jan;50:34-66. doi: 10.1016/j.preteyeres.2015.10.003. Epub 2015 Nov 2.
Velilla S, Garcia-Medina JJ, Garcia-Layana A, Dolz-Marco R, Pons-Vazquez S, Pinazo-Duran MD, Gomez-Ulla F, Arevalo JF, Diaz-Llopis M, Gallego-Pinazo R. Smoking and age-related macular degeneration: review and update. J Ophthalmol. 2013;2013:895147. doi: 10.1155/2013/895147. Epub 2013 Dec 4.
Chiu CJ, Chang ML, Zhang FF, Li T, Gensler G, Schleicher M, Taylor A. The relationship of major American dietary patterns to age-related macular degeneration. Am J Ophthalmol. 2014 Jul;158(1):118-127.e1. doi: 10.1016/j.ajo.2014.04.016. Epub 2014 Apr 29.
Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.
Algvere PV, Marshall J, Seregard S. Age-related maculopathy and the impact of blue light hazard. Acta Ophthalmol Scand. 2006 Feb;84(1):4-15. doi: 10.1111/j.1600-0420.2005.00627.x.
Behar-Cohen F, Martinsons C, Vienot F, Zissis G, Barlier-Salsi A, Cesarini JP, Enouf O, Garcia M, Picaud S, Attia D. Light-emitting diodes (LED) for domestic lighting: any risks for the eye? Prog Retin Eye Res. 2011 Jul;30(4):239-57. doi: 10.1016/j.preteyeres.2011.04.002. Epub 2011 May 14.
Widomska J, Subczynski WK. Why has Nature Chosen Lutein and Zeaxanthin to Protect the Retina? J Clin Exp Ophthalmol. 2014 Feb 21;5(1):326. doi: 10.4172/2155-9570.1000326.
Liu T, Liu WH, Zhao JS, Meng FZ, Wang H. Lutein protects against beta-amyloid peptide-induced oxidative stress in cerebrovascular endothelial cells through modulation of Nrf-2 and NF-kappab. Cell Biol Toxicol. 2017 Feb;33(1):57-67. doi: 10.1007/s10565-016-9360-y. Epub 2016 Nov 22.
Frede K, Ebert F, Kipp AP, Schwerdtle T, Baldermann S. Lutein Activates the Transcription Factor Nrf2 in Human Retinal Pigment Epithelial Cells. J Agric Food Chem. 2017 Jul 26;65(29):5944-5952. doi: 10.1021/acs.jafc.7b01929. Epub 2017 Jul 13.
Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033.
Romieu I, Parra S, Hernandez JF, Madrigal H, Willett W, Hernandez M. Questionnaire assessment of antioxidants and retinol intakes in Mexican women. Arch Med Res. 1999 May-Jun;30(3):224-39. doi: 10.1016/s0188-0128(99)00017-2.
McNaughton SA, Marks GC, Gaffney P, Williams G, Green A. Validation of a food-frequency questionnaire assessment of carotenoid and vitamin E intake using weighed food records and plasma biomarkers: the method of triads model. Eur J Clin Nutr. 2005 Feb;59(2):211-8. doi: 10.1038/sj.ejcn.1602060.
Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047.
Cartmel B, Moon TE. Comparison of two physical activity questionnaires, with a diary, for assessing physical activity in an elderly population. J Clin Epidemiol. 1992 Aug;45(8):877-83. doi: 10.1016/0895-4356(92)90071-t.
Park Y, Dodd KW, Kipnis V, Thompson FE, Potischman N, Schoeller DA, Baer DJ, Midthune D, Troiano RP, Bowles H, Subar AF. Comparison of self-reported dietary intakes from the Automated Self-Administered 24-h recall, 4-d food records, and food-frequency questionnaires against recovery biomarkers. Am J Clin Nutr. 2018 Jan 1;107(1):80-93. doi: 10.1093/ajcn/nqx002.
Williams R, Bakshi S, Ostrin EJ, Ostrin LA. Continuous Objective Assessment of Near Work. Sci Rep. 2019 May 6;9(1):6901. doi: 10.1038/s41598-019-43408-y.
Black AE. Critical evaluation of energy intake using the Goldberg cut-off for energy intake:basal metabolic rate. A practical guide to its calculation, use and limitations. Int J Obes Relat Metab Disord. 2000 Sep;24(9):1119-30. doi: 10.1038/sj.ijo.0801376.
Black AE. The sensitivity and specificity of the Goldberg cut-off for EI:BMR for identifying diet reports of poor validity. Eur J Clin Nutr. 2000 May;54(5):395-404. doi: 10.1038/sj.ejcn.1600971.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04779411