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Trial on the Effect of E-cigarette Advertising on Cigarette Perceptions in Adolescents

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ClinicalTrials.gov Identifier: NCT03786042
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Dartmouth College
Information provided by (Responsible Party):
Diane Gilbert-Diamond, Dartmouth-Hitchcock Medical Center

Brief Summary:
This research aims to investigate how exposure to advertising for Electronic Nicotine Delivery Systems (commonly called e-cigarettes) may lead to combustible smoking initiation in adolescents.

Condition or disease Intervention/treatment Phase
Attentional Bias Smoking Cues Positive Perceptions About Cigarette Smoking Social Norms Smoking Susceptibility Behavioral: E-cigarette ad exposure Other: non e-cigarette TV commercials Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Does Exposure to Electronic Nicotine Delivery Systems Advertising Affect Positive Smoking Expectancies and Social Normative Beliefs About Smoking?
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

Arm Intervention/treatment
Active Comparator: E-cigarette ad exposure Behavioral: E-cigarette ad exposure
Participants view a series of e-cigarette TV commercials

Sham Comparator: non e-cigarette ad exposure Other: non e-cigarette TV commercials
Participants view a series of non e-cigarette TV commercials




Primary Outcome Measures :
  1. change in baseline in implicit positive smoking expectancies, measured by the implicit association test [ Time Frame: baseline, within 5 minutes post intervention ]
    Scores are measured by recording the amount of time (reaction time) it takes to categorize smoking-related words with positive (e.g., cool) and negative (e.g., cancer) words. Faster reaction times when categorizing smoking-related words with positive words is evidence of higher positive smoking expectancies.

  2. Amount of time spent looking at static smoking cues in e-cigarette advertisements [ Time Frame: approximately 30 minutes post intervention ]
    Eye-tracking will be used to measure the amount of time spent looking at static smoking cues in screen shots taken from e-cigarette advertisements. The amount time spent looking at a smoking cue is a measure how much attention was given to the smoking cue. The longer the looking time, the greater amount of attention.

  3. 7-item explicit positive smoking expectancies scale [ Time Frame: approximately 30 minutes post intervention ]
    Scores are measured on a 7-item scale. Positive smoking expectancies will be assessed using the following questions that follow the lead-in, "Please tell me how you feel about the following statements." "I think I would enjoy smoking"; "I think smoking would give me something to do when I'm bored"; "I think smoking would help me deal with problems or stress"; "I think smoking would help me stay thin"; "I think smoking would help me to feel more comfortable at parties"; "I think smoking would be relaxing"; and "I think smoking would make me look older." Responses are yes/no. Responses are coded as "1" for yes and "0" for no. Responses are then summed for a maximum positive smoking expectancy score out of 7. Higher scores mean higher positive smoking expectancies.

  4. 11-item scale that measures social normative beliefs about smoking [ Time Frame: approximately 30 minutes post intervention ]
    This 11-item scale assess social normative beliefs about smoking related to 1) perceived disapproval from family/friends, 2) perceived popularity among successful/elite, and 3) perceived prevalence. Disapproval scale questions are answered using a 4-point Likert scale (1 = Strongly disagree; 4 = Strongly agree). A total disapproval score (ranging from 1 to 4) is calculated by averaging responses to each question. Higher values indicate a higher disapproval score. Popularity scale questions are answered using a 4-point Likert scale (1 = Strongly disagree; 4 = Strongly agree). A total popularity score (ranging from 1 to 4) is calculated by averaging responses to each question. Higher values indicate a higher popularity score. Prevalence scale questions are answered using a percent scale from 0 - 100% in 10% increments. A total prevalence scale (from 0 to 100) is calculated by averaging the responses to each question. Higher values indicate a higher prevalence score.

  5. A 3-item scale that measures adolescent smoking susceptibility [ Time Frame: approximately 30 minutes post intervention ]
    This 3-item instrument is used to predict which never smokers are likely to start smoking by measuring their curiosity to use tobacco products. Item responses are on a 4-point Likert scale (definitely yes, probably yes, probably not, definitely not). To classify a respondent as not susceptible to smoking, the respondent must indicate "definitely not" to all four items. Any other response to any item classifies a respondent as "susceptible."


Secondary Outcome Measures :
  1. Amount of time looking at dynamic smoking cues in e-cigarette advertisements [ Time Frame: During the intervention, approximately 15 minutes post baseline ]
    Eye-tracking will be used to measure the total amount of time spent looking in realtime at smoking cues in TV commercials for e-cigarettes. The amount of time looking at smoking cues will be a measure of the amount of attention given to smoking cues. The longer the amount of time spent looking at smoking cues indicates that a greater amount of attention was given to the smoking cues.

  2. 18-item scale that measures character attributes of actors that appeared in the commercials [ Time Frame: approximately 30 minutes post intervention ]
    Character Attributes will be collected using a scale that measures participants beliefs about character attributes using the lead in: "I think [Character Name] is: " using a 5-point Likert (1 = strongly disagree; 5 = strongly agree). There is a total of 6 attributes assessed: 1) smart (smart, intelligent, stupid), 2) successful (successful, achieves goals, gets what he/she wants), 3) attractive (physically attractive, ugly, good-looking), 4) funny (funny, humorous, makes me laugh), 5) respected (respected by others, receives approval, criticized by others), and 6) popular (has lots of friends, well liked, gets support from others). A total score (form 1 to 5) for each scale is calculated by averaging responses for each question within that scale. For each scale, a higher total score indicates higher beliefs about that attribute.

  3. 5-item scale that measure how much participants wish to be like the actors appearing in the commercials. [ Time Frame: approximately 30 minutes post intervention ]
    This 5-item is scale is used to quantify how much a participant would like to be like an actor appearing in a commercial. Questions are rated on a 5-point Likert scale (1 = Strongly Disagree; 5 = Strongly agree). A total identification score (from 1 to 25) is calculated by summing the responses to each question. A higher total score indicates a higher level of wishful identification.

  4. 13-item scale to measure risk perception about cigarette use [ Time Frame: approximately 30 minutes post intervention ]
    This 13-item scale measures risk perceptions associated with cigarette use. Questions are answered using a sliding percent scale from 0 - 100% in 10% increments. A risk perception scale is calculated (from 0 to 100) by averaging the responses to each question. Higher values indicate a higher risk perception.

  5. 13-item scale to Measure risk perception about e-cigarette use [ Time Frame: approximately 30 minutes post intervention ]
    This 13-item scale measures risk perceptions associated with e-cigarette use. Questions are answered using a sliding percent scale from 0 - 100% in 10% increments. A risk perception scale is calculated (from 0 to 100) by averaging the responses to each question. Higher values indicate a higher risk perception.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Exclusion criteria will include inadequate English proficiency, and diagnosis of a learning or vision disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786042


Contacts
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Contact: Reina Lansigan 917-915-3686 Reina.Lansigan@dartmouth.edu
Contact: John Brand, PhD 603-653-3635 john.brand@dartmouth.edu

Locations
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United States, New Hampshire
Dartmouth-Hithchock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Reina Lansigan         
Principal Investigator: Diane Gilbert-Diamond, ScD         
Principal Investigator: James Sargent, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Dartmouth College
Investigators
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Principal Investigator: James Sargent, MD Geisel School of Medicine at Dartmouth College
Principal Investigator: Diane Gilbert-Diamond, ScD Geisel School of Medicine at Dartmouth College

Publications:
Centers for Disease Control and Prevention. 2012 Surgeon General's Report—Preventing tobacco use among youth and young adults. (2012).
National Cancer Institute. The role of the media in promoting and reducing tobacco use. Tobacco control monograph No. 19. (2008).
Centers for Disease Control and Prevention. Smoking in Movies. Available at: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/movies/index.htm. (Accessed: 5 November 2016)
US Department of Health and Human Services. The health consequences of smoking - 50 years of progress. (2014).
R, W. & A, S. Handbook of implicit cognition and addiction. (Sage, 2006).
Gerrard, M., Gibbons, F. X., Houlihan, A. E., Stock, M. L. & Pomery, E. A. A dual-process approach to health risk decision making: The prototype willingness model. Dev Rev 28, 29-61 (2008).
Field, M. & Wiers, R. in Drug Abuse and Addiction in Medical Illness: Causes, Consequences and Treatment (eds. Verster, J. C., Brady, K., Galanter, M. & Conrod, P.) 35-45 (Springer New York, 2012).
Yoshida, E., Peach, J. M., Zanna, M. P. & Spencer, S. J. Not all automatic associations are created equal: How implicit normative evaluations are distinct from implicit attitudes and uniquely predict meaningful behavior. J Exp Soc Psychol 48, 694-706 (2012).
Gilbert, D. G. & Rabinovich, N. E. International smoking series (with neural counterparts) verion 1.2. (1999).

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Responsible Party: Diane Gilbert-Diamond, Associate Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03786042     History of Changes
Other Study ID Numbers: D19034
1R21CA232054-01 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diane Gilbert-Diamond, Dartmouth-Hitchcock Medical Center:
Positive Smoking expectancies
e-cigarette advertising
adolescents

Additional relevant MeSH terms:
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Disease Susceptibility
Disease Attributes
Pathologic Processes