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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA239192 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Participants will view six sample waterpipe tobacco packages, randomized at the package level to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website pages) either with or without prohibited or potentially-prohibited claim, randomized at the advertisements level (Digital Marketing Task).
Background/Objectives The Food and Drug Administration (FDA) has begun to prohibit certain claims on Waterpipe Tobacco (WT) packaging and advertising. Under Section 911 of the Family Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of a substance or presents a reduced exposure to a substance; (3) does not contain or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or similar descriptors. Some prohibited claims are easily identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of some claims. Evidence is needed specific to WT packaging and marketing to determine which claims may be associated with consumer harm misperceptions to inform future regulatory actions. The study will address this gap by assessing how such claims influence consumer perceptions and behavioral intentions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Claim 0% Tar | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim 0% Tar | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim No Chemicals | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim No Chemicals | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Apple Image | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Apple Image |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Package/Advertisement With Claim | Behavioral | Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to Try Hookah Tobacco (Packaging Task ) | One item to assess the extent to which young adults are willing to try the waterpipe tobacco product: How likely would you be to try this specific product? Response scale: (1) Not at all likely to (4) Very likely | minute 5 |
| Willingness to Smoke Hookah Tobacco (Digital Marketing Task ) | One item to assess the extent to which young adults want to try smoking hookah: How much does this advertisement make you want to smoke hookah? Response scale: (1) Not at all to (4) A lot | minute 5 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Harm Perception (Packaging Task ) | One item to assess young adults' perceptions of how the packaging influences their opinions on the harmfulness of the hookah tobacco: How much does this packaging make you think this product is harmful? Response scale: (1) Not at all to (4) A lot | minute 5 |
| Absolute Harm Perception (Digital Marketing Task ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Sutfin, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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Participants were randomized to see 6 packages and 10 advertisements with/without the claim of interest on each (32 arms). The randomization was repeated prior to each claim of interest. 1507 unique were enrolled in total.
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| ID | Title | Description |
|---|---|---|
| FG000 | With Claim | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| FG001 | Without Claim | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zero Percent Tar |
| |||||||||||||
| No Chemicals |
| |||||||||||||
| Apple Image |
| |||||||||||||
| Hundred Percent Food Grade Glycerin |
| |||||||||||||
| Ultra Light |
| |||||||||||||
| Fresh Hookah Tobacco |
| |||||||||||||
| Lower Nicotine Tobacco |
| |||||||||||||
| Premium Shisha Tobacco |
| |||||||||||||
| High Quality Shisha Tobacco |
| |||||||||||||
| Don't Blow Smoke - Blow Clouds |
| |||||||||||||
| Contains Natural, Unwashed Tobacco Leaf |
| |||||||||||||
| We Only Use FDA Approved Ingredients |
| |||||||||||||
| H2O Cools Puirfies Tobacco Smoke |
| |||||||||||||
| Natural Flavor |
| |||||||||||||
| Shisha/Hookah Tobacco is Unique |
| |||||||||||||
| Shisha H2O Cools and Filters Smoke |
|
Participants were randomized to see 6 packages and 10 advertisements with/without the claim of interest on each (32 arms). The randomization was repeated prior to each claim of interest. 1507 unique were enrolled in total.
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| ID | Title | Description |
|---|---|---|
| BG000 | With Claim | Package or digital marketing advertisement containing claim of interest Package / Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| BG001 | Without Claim |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Willingness to Try Hookah Tobacco (Packaging Task ) | One item to assess the extent to which young adults are willing to try the waterpipe tobacco product: How likely would you be to try this specific product? Response scale: (1) Not at all likely to (4) Very likely | Only certain Arms involved the Packaging Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
From the time of consent up to about 4 weeks
Participants will be randomized to see 6 packages and 10 advertisements with/without the claim of interest on each (32 arms). The randomization was repeated prior to each claim of interest. 1507 unique were enrolled in total. AEs are represented in male/female groups because it does not repeat as the arms do.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Male | Male participants | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin L. Sutfin, PhD | Wake Forest University Health Sciences | 336.713.5282 | esutfin@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2022 | Sep 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004349 | Drug Packaging |
| ID | Term |
|---|---|
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D004345 | Drug Industry |
| D066192 | Manufacturing Industry |
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Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
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Participants will be blinded to which stimuli have the claims of interest and which do not.
Package or digital marketing advertisement without claim of interest |
|
| With Claim 100% Food Grade Glycerin | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim 100% Food Grade Glycerin | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Ultra Light | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Ultra Light | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Fresh Hookah Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Fresh Hookah Tobacco | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Lower Nicotine Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Lower Nicotine Tobacco | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Premium Shisha Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Premium Shisha Tobacco | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim High Quality Shisha Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim High Quality Shisha Tobacco | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Don't blow smoke - blow clouds | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Don't blow smoke - blow clouds | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Contains natural, unwashed tobacco leaf | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Contains natural, unwashed tobacco leaf | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim We only use ingredients which are FDA approved | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim We only use ingredients which are FDA approved | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Passing flavored tobacco smoke through water cools and purifies it | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Passing flavored tobacco smoke through water cools and purifies it | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Natural flavor | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Natural flavor | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes | Experimental | Package or digital marketing advertisement without claim of interest |
|
| With Claim water in the shisha effectively cools and filters the smoke, making smooth and light | Experimental | Package or digital marketing advertisement containing claim of interest |
|
| Without Claim water in the shisha effectively cools and filters the smoke, making smooth and light | Experimental | Package or digital marketing advertisement without claim of interest |
|
| Package/Advertisement Without Claim | Behavioral | Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
|
One item to assess young adults' perception of how the advertisement influences their opinions on the harmfulness of smoking hookah: How much does this advertisement make you think smoking hookah is harmful? Response scale: (1) Not at all to (4) A lot |
| minute 5 |
| Product Appeal (Packaging Task ) | One item to assess the pictured product's appeal: How appealing is this specific product to you? Response scale: (1) Not at all appealing to (4) Very appealing | minute 5 |
| Product Appeal (Digital Marketing Task ) | One item to assess the appeal of smoking hookah in the context of the advertisement: How appealing does this advertisement make smoking hookah seem to you? Response scale: (1) Not at all appealing to (4) Very appealing | minute 5 |
| Absolute Safety Perception (Packaging Task) | One item to assess young adults' perceptions of how the packaging influences their opinions of how safe the product is: How much does this packaging make you think this product is safe? Response scale: (1) Not at all to (4) A lot | minute 5 |
| Absolute Safety Perception (Digital Marketing Task) | One item to assess young adults' perception of how the advertisement influences their opinions on the safety of smoking hookah: How much does this advertisement make you think smoking hookah is safe? Response scale: (1) Not at all to (4) A lot | minute 5 |
| Relative Safety Perception (Packaging Task | One item to assess young adults' perceptions of how safe the product is as compared to other hookah tobacco that might be available to them: Compared to other hookah tobacco on the market, how safe do you think this specific product is? Response scale: (1) Much less safe to (5) Much more safe | minute 5 |
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Package or digital marketing advertisement without claim of interest Package / Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Package or digital marketing advertisement without claim of interest
Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design
| OG002 | With Claim No Chemicals | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG003 | Without Claim No Chemicals | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG004 | With Claim Apple Image | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG005 | Without Claim Apple Image | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG006 | With Claim 100% Food Grade Glycerin | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG007 | Without Claim 100% Food Grade Glycerin | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG008 | With Claim Ultra Light | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG009 | Without Claim Ultra Light | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG010 | With Claim Fresh Hookah Tobacco | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG011 | Without Claim Fresh Hookah Tobacco | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG012 | With Claim Lower Nicotine Tobacco | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG013 | Without Claim Lower Nicotine Tobacco | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG014 | With Claim Premium Shisha Tobacco | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG015 | Without Claim Premium Shisha Tobacco | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG016 | With Claim High Quality Shisha Tobacco | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG017 | Without Claim High Quality Shisha Tobacco | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG018 | With Claim Don't Blow Smoke - Blow Clouds | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG019 | Without Claim Don't Blow Smoke - Blow Clouds | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG020 | With Claim Contains Natural, Unwashed Tobacco Leaf | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG021 | Without Claim Contains Natural, Unwashed Tobacco Leaf | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG022 | With Claim We Only Use Ingredients Which Are FDA Approved | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG023 | Without Claim We Only Use Ingredients Which Are FDA Approved | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG024 | With Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies it | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG025 | Without Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies it | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG026 | With Claim Natural Flavor | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG027 | Without Claim Natural Flavor | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG028 | With Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in Cigarettes | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG029 | Without Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in Cigarettes | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
| OG030 | With Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light | Package or digital marketing advertisement containing claim of interest Package/Advertisement With Claim: Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design |
| OG031 | Without Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light | Package or digital marketing advertisement without claim of interest Package/Advertisement Without Claim: Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design |
|
|
| Primary | Willingness to Smoke Hookah Tobacco (Digital Marketing Task ) | One item to assess the extent to which young adults want to try smoking hookah: How much does this advertisement make you want to smoke hookah? Response scale: (1) Not at all to (4) A lot | Only certain Arms involved the Digital Marketing Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Absolute Harm Perception (Packaging Task ) | One item to assess young adults' perceptions of how the packaging influences their opinions on the harmfulness of the hookah tobacco: How much does this packaging make you think this product is harmful? Response scale: (1) Not at all to (4) A lot | Only certain Arms involved the Packaging Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Absolute Harm Perception (Digital Marketing Task ) | One item to assess young adults' perception of how the advertisement influences their opinions on the harmfulness of smoking hookah: How much does this advertisement make you think smoking hookah is harmful? Response scale: (1) Not at all to (4) A lot | Only certain Arms involved the Digital Marketing Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Product Appeal (Packaging Task ) | One item to assess the pictured product's appeal: How appealing is this specific product to you? Response scale: (1) Not at all appealing to (4) Very appealing | Only certain Arms involved the Packaging Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Product Appeal (Digital Marketing Task ) | One item to assess the appeal of smoking hookah in the context of the advertisement: How appealing does this advertisement make smoking hookah seem to you? Response scale: (1) Not at all appealing to (4) Very appealing | Only certain Arms involved the Digital Marketing Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Absolute Safety Perception (Packaging Task) | One item to assess young adults' perceptions of how the packaging influences their opinions of how safe the product is: How much does this packaging make you think this product is safe? Response scale: (1) Not at all to (4) A lot | Only certain Arms involved the Packaging Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Absolute Safety Perception (Digital Marketing Task) | One item to assess young adults' perception of how the advertisement influences their opinions on the safety of smoking hookah: How much does this advertisement make you think smoking hookah is safe? Response scale: (1) Not at all to (4) A lot | Only certain Arms involved the Digital Marketing Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| Other Pre-specified | Relative Safety Perception (Packaging Task | One item to assess young adults' perceptions of how safe the product is as compared to other hookah tobacco that might be available to them: Compared to other hookah tobacco on the market, how safe do you think this specific product is? Response scale: (1) Much less safe to (5) Much more safe | Only certain Arms involved the Packaging Experiment | Posted | Mean | Standard Error | score on a scale | minute 5 |
|
|
|
| 538 |
| 0 |
| 538 |
| 0 |
| 538 |
| EG001 | Female | Female Participants | 0 | 969 | 0 | 969 | 0 | 969 |
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Not provided
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D019064 | Product Packaging |