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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03786042
Other study ID # D19034
Secondary ID 1R21CA232054-01
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2019
Est. completion date December 9, 2021

Study information

Verified date May 2022
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

[3/14/2020]: Study recruitment temporarily halted due to the COVID-19 pandemic


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date December 9, 2021
Est. primary completion date December 9, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria: - Exclusion Criteria: - Exclusion criteria will include inadequate English proficiency, and diagnosis of a learning or vision disorder.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
E-cigarette ad exposure
Participants view a series of e-cigarette TV commercials
Other:
non e-cigarette TV commercials
Participants view a series of non e-cigarette TV commercials

Locations

Country Name City State
United States Dartmouth-Hithchock Medical Center Lebanon New Hampshire

Sponsors (3)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Dartmouth College, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (54)

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King AC, Smith LJ, Fridberg DJ, Matthews AK, McNamara PJ, Cao D. Exposure to electronic nicotine delivery systems (ENDS) visual imagery increases smoking urge and desire. Psychol Addict Behav. 2016 Feb;30(1):106-12. doi: 10.1037/adb0000123. Epub 2015 Nov 30. — View Citation

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* Note: There are 54 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary change in baseline in implicit positive smoking expectancies, measured by the implicit association test 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. baseline, within 5 minutes post intervention
Primary Amount of time spent looking at static smoking cues in e-cigarette advertisements 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. approximately 30 minutes post intervention
Primary 7-item explicit positive smoking expectancies scale 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. approximately 30 minutes post intervention
Primary 11-item scale that measures social normative beliefs about smoking 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. approximately 30 minutes post intervention
Primary A 3-item scale that measures adolescent smoking susceptibility 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." approximately 30 minutes post intervention
Secondary Amount of time looking at dynamic smoking cues in e-cigarette advertisements 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. During the intervention, approximately 15 minutes post baseline
Secondary 18-item scale that measures character attributes of actors that appeared in the commercials 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. approximately 30 minutes post intervention
Secondary 5-item scale that measure how much participants wish to be like the actors appearing in the commercials. 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. approximately 30 minutes post intervention
Secondary 13-item scale to measure risk perception about cigarette use 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. approximately 30 minutes post intervention
Secondary 13-item scale to Measure risk perception about e-cigarette use 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. approximately 30 minutes post intervention
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