Correcting Public Misperceptions About Very Low Nicotine... | NCT04974489

NCT04974489

ID	Type	Description	Link
R21CA234968	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Emotion-based messages about the harm of VLNC	Experimental	Behavioral: Emotion-based messages about the harm of VLNC
Continued-harm-framed messages about the harm of VLNC	Experimental	Behavioral: Continued-harm-framed messages about the harm of VLNC
Myth-refuting messages about the harm of VLNC	Experimental	Behavioral: Myth-refuting messages about the harm of VLNC
Control messages about littering	Active Comparator	Behavioral: Control messages about littering

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emotion-based messages about the harm of VLNC	Behavioral	Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Very Low Nicotine Content (VLNC) Misperception	Measured by a 3 item scale. Very low nicotine content (VLNC) Misperception measured with 3 questions, the final VLNC misperception score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more harmful than other cigarettes, and 5 indicates a perception that VLNC are much less harmful than other cigarettes, and 3 is a perception that VLNC are as harmful as other cigarettes.	During one day survey
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized)	Very low nicotine content (VLNC) Misperception of Harm was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more harmful than other cigarettes, and 5 indicates a perception that VLNC are much less harmful than other cigarettes, and 3 is a perception that VLNC are as harmful as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).	During one day survey
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized)	Very low nicotine content (VLNC) Misperception of Risk of Cancer was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more likely to cause cancer than other cigarettes, and 5 indicates a perception that VLNC are much less likely to cause cancer than other cigarettes, and 3 is a perception that VLNC are as likely to cause cancer as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).	During one day survey

Secondary Outcomes

Measure	Description	Time Frame
Quit Intentions	Measured by a 3 item scale. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low intention to quit smoking, and 5 indicates a high intention to quit.	During one day survey

Other Outcomes

Measure	Description	Time Frame
Perceived Message Effectiveness	Measured by a 3 item scale after each message, 9 items total. Perceived message effectiveness measured with 3 questions per message. The final perceived message effectiveness score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low perceived message effectiveness, and 5 indicates high perceived message effectiveness.	During one day survey

Eligibility Module

Name	Affiliation	Role
M. Justin Byron, PhD	University of North Carolina, Chapel Hill	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina, Chapel Hill		Chapel Hill	North Carolina	27514	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
FG001	Continued-harm-framed Messages About the Harm of VLNC

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Jul 28, 2022

Arm/Group Information

ID	Title	Description
BG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
BG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
BG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.
BG003	Control Messages About Littering	Control messages about littering: Participants in this arm will receive 3 control messages about littering during the survey data collection.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000262 BG001261 BG002263 BG003267 BG0041053

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054.1± 13.7 BG00154.6± 13.6 BG00254.4± 13.2 BG003

Sex/Gender, Customized

Count of Participants

Participants

Title

Denominators

Categories

Male

Title	Measurements
	BG000138 BG001131 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White, Non-Hispanic

Title	Measurements
	BG000201 BG001203 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000262 BG001261 BG002

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

Very Low Nicotine Content (VLNC) Misperception

Measured by a 3 item scale. Very low nicotine content (VLNC) Misperception measured with 3 questions, the final VLNC misperception score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more harmful than other cigarettes, and 5 indicates a perception that VLNC are much less harmful than other cigarettes, and 3 is a perception that VLNC are as harmful as other cigarettes.

Posted

Mean

Standard Deviation

score on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.
OG003	Control Messages About Littering	Control messages about littering: Participants in this arm will receive 3 control messages about littering during the survey data collection.

Units	Counts
Participants	OG000262 OG001261 OG002263 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.12± 0.56 OG0013.04± 0.61 OG0023.04± 0.54 OG003

Secondary

Quit Intentions

Measured by a 3 item scale. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low intention to quit smoking, and 5 indicates a high intention to quit.

Overall number of participants analyzed is the number of participants in each condition that responded to all 3 questions for the outcome measure.

Posted

Mean

Standard Deviation

score on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Perceived Message Effectiveness

Measured by a 3 item scale after each message, 9 items total. Perceived message effectiveness measured with 3 questions per message. The final perceived message effectiveness score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low perceived message effectiveness, and 5 indicates high perceived message effectiveness.

Overall number of participants analyzed is the number of participants in each condition that responded to all 9 questions for the outcome measure

Posted

Mean

Standard Deviation

score on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Perceived Understandability

Perceived Understandability is measured with 1 question on a scale of 1 to 5: "How easy was it to understand the three black and white messages we showed you earlier?", where 1 = "Not at all", 5 = "Very", and 3 = "Somewhat"

Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure

Posted

Mean

Standard Deviation

units on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Attention

Attention is measured with 1 question on a scale of 1 to 5: "How much did the messages grab your attention?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure

Posted

Mean

Standard Deviation

units on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Negative Affect

Negative affect is measured with 1 question on a scale of 1 to 5: "How much did the messages make you feel scared?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure

Posted

Mean

Standard Deviation

units on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Cognitive Reactions

Cognitive Reactions are measured with 1 question on a scale of 1 to 5: "How much did the messages make you think about the risk of smoking cigarettes that have 95% less nicotine?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure

Posted

Mean

Standard Deviation

units on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Social Interactions

Social Interactions are measured with 1 question on a scale of 1 to 5: "How much would you talk with other people about the messages?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure

Posted

Mean

Standard Deviation

units on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Reactance

Reactance is measured with 1 question on a scale of 1 to 5: "How much do you feel that the messages are trying to manipulate you?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

Overall number of participants analyzed is the number of participants in each condition that responded to the outcome measure

Posted

Mean

Standard Deviation

units on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Other Pre-specified

Interest in Other Nicotine Products

Measured by a 3 item scale. Interest in other nicotine products with 3 questions, the final score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low interest in other nicotine products, and 5 indicates a high interest in other nicotine products.

Overall number of participants analyzed is the number of participants in each condition that responded to all 3 questions for the outcome measure

Posted

Mean

Standard Deviation

score on a scale

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Primary

Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized)

Very low nicotine content (VLNC) Misperception of Harm was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more harmful than other cigarettes, and 5 indicates a perception that VLNC are much less harmful than other cigarettes, and 3 is a perception that VLNC are as harmful as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).

Posted

Number

95% Confidence Interval

percentage of participants

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
OG002

Primary

Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized)

Very low nicotine content (VLNC) Misperception of Risk of Cancer was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more likely to cause cancer than other cigarettes, and 5 indicates a perception that VLNC are much less likely to cause cancer than other cigarettes, and 3 is a perception that VLNC are as likely to cause cancer as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).

Posted

Number

95% Confidence Interval

percentage of participants

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.

Primary

Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Death (Dichotomized)

Very low nicotine content (VLNC) Misperception of Risk of Death was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more likely to cause death than other cigarettes, and 5 indicates a perception that VLNC are much less likely to cause death than other cigarettes, and 3 is a perception that VLNC are as likely to cause death as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).

Posted

Number

95% Confidence Interval

percentage of participants

During one day survey

ID	Title	Description
OG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
OG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.

Arm/Groups

ID	Title	Description
EG000	Emotion-based Messages About the Harm of VLNC	Emotion-based messages about the harm of VLNC: Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
EG001	Continued-harm-framed Messages About the Harm of VLNC	Continued-harm-framed messages about the harm of VLNC: Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
EG002	Myth-refuting Messages About the Harm of VLNC	Myth-refuting messages about the harm of VLNC: Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.
EG003	Control Messages About Littering	Control messages about littering: Participants in this arm will receive 3 control messages about littering during the survey data collection.