Cigarillo Warnings Image Sorting Study

Sponsor
Boston University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05838378
Collaborator
National Cancer Institute (NCI) (NIH), Wake Forest University Health Sciences (Other), Brown University (Other)
500
1
3
9
55.5

Study Details

Study Description

Brief Summary

The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format.

For 6 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of ~20 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert).

An additional survey will be conducted 4 weeks later to determine any lasting effects of the warning intervention. Participants will then be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation.

The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.

Condition or Disease Intervention/Treatment Phase
  • Other: Package image sorting with pictorial warnings
  • Other: Package image sorting with Surgeon General text-only warnings
  • Other: Package image sorting with FDA text-only warnings
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users, Aim 2 Survey
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pictorial warnings

Participants randomized to this group will view pictorial cigarillo warnings.

Other: Package image sorting with pictorial warnings
Weekly for six weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with pictorial warnings on each pack.

Active Comparator: FDA text-only warnings

Participants randomized to this group will view FDA text-only warnings.

Other: Package image sorting with FDA text-only warnings
Weekly for six weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with FDA text-only warnings on each pack.

Active Comparator: Surgeon General text-only warnings

Participants randomized to this group will view Surgeon General text-only warnings.

Other: Package image sorting with Surgeon General text-only warnings
Weekly for six weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with Surgeon General text-only warnings on each pack.

Outcome Measures

Primary Outcome Measures

  1. Intention to quit smoking cigarillos in the next 30 days at baseline [Baseline]

    Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit.

  2. Intention to quit smoking cigarillos in the next 30 days at weeks 2-6 [Weeks 2-6]

    Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit.

  3. Intention to quit smoking cigarillos in the next 30 days at 10 weeks [Week 10]

    Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit.

Secondary Outcome Measures

  1. Cigarillo smoking behavior in the past week [Baseline, Weeks 2-6, Week 10]

    Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking?

Other Outcome Measures

  1. Quitting self-efficacy based on anticipated success [Baseline, Weeks 2-6, Week 10]

    Assessed by a single survey item asking how successful participants think they would be if they tried to quit smoking in the next 30 days. The survey item has a 5-pt response scale (0=Not at all to 5= Extremely).

  2. Quitting self-efficacy based on a quit ladder [Baseline, Weeks 2-6, Week 10]

    Assessed by an image of a quit ladder, asking participants where they are now on the ladder in regards to cigarillo smoking (1 no thought of quitting - 10 taking action to quit).

  3. Blunting behaviors past week [Baseline, Weeks 2-6, Week 10]

    Assessed with two items: one asking the number of days in the past week that the participant smoked a cigarillo with marijuana ("blunt"), response scale 0 - 7 days; and the second asking what proportion of the cigarillos smoked in the past week were smoked as blunts, response options 0 = no cigarillos smoked to 4 = all

  4. Warning recall [Baseline, Weeks 2-6, Week 10]

    Assessed by one survey item asking participants if they noticed any health warnings on the cigarillo packages during the study, with response options of Yes, No, and I'm not sure. Recall is defined as a "Yes" response.

  5. Warning recognition [Baseline, Weeks 2-6, Week 10]

    Assessed by one survey item asking participants to identify which warning they saw during the study period. Participants will be shown their warning, a warning they did not see, and "I don't know" response options. Selecting the correct warning indicates warning recognition.

  6. Warning reactions [Baseline, Weeks 2-6, Week 10]

    Assessed by four survey items assessing participants' perceptions of the warning for 1) grabbing attention; 2) eliciting disgust/emotions; 3) thinking about the risks; 4) self-reported learning. Response options from 1 = not at all to 5 = very much.

  7. Beliefs about harms associated with cigarillo smoking [Baseline, Weeks 2-6, Week 10]

    Assessed by 10 survey items on participant's beliefs about the harms associated with cigarillo smoking, such as relative risk to cigarettes, getting cancer, and inhaling harmful chemicals. 5 point response scale (1=strongly disagree to 5=strongly agree). Higher scores are associated with stronger beliefs about the harms associated with cigarillo smoking.

  8. Knowledge about harms associated with cigarillo smoking [Baseline, Weeks 2-6, Week 10]

    Assessed by 9 survey items on participant's knowledge about the harms associated with cigarillo smoking, such as cigarillos being addictive and causing heart disease with three response options: True, False, I don't know.

  9. Social interactions [Week 6, Week 10]

    Assessed with 3 survey items about: 1) the frequency in which participants talked to others about the harms of cigarillo smoking, 20 quitting cigarillo smoking, or 3) about the packages in the study. Response options range from 1 = never to 5 = 10 times or more.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Current cigarillo user-used cigarillos at least one time per week in the past month

  • Recruited through Qualtrics Research Services

Exclusion Criteria:
  • Not recruited through Qualtrics Research Services

  • Non-English speaking

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston University School of Public Health, study online Boston Massachusetts United States 02118

Sponsors and Collaborators

  • Boston University
  • National Cancer Institute (NCI)
  • Wake Forest University Health Sciences
  • Brown University

Investigators

  • Principal Investigator: Jennifer Ross, PhD, School of Public Health - Health Law Policy & Management Dept

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston University
ClinicalTrials.gov Identifier:
NCT05838378
Other Study ID Numbers:
  • H-43316
  • R01CA260460
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston University

Study Results

No Results Posted as of May 1, 2023