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

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779411
• Other study ID #: FFQEDUQ20V1
• Status: Completed
• Start date: August 18, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2022
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Blue Light Exposure
• Electronic Device Use
• Lutein and Zeaxanthin Dietary Intake
• Macular Degeneration

Intervention

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.
• 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.
• 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
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.
• 24-Hour Electronic Device Use Diary
Participants asked to record their electronic device use in hours and minutes over 24 hours.

Locations

Country	Name	City	State
Australia	University of Queensland	St Lucia	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
The University of Queensland

Country where clinical trial is conducted

Australia, 

References & Publications (19)

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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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

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

External Links

•   USDA Food Composition Database