Project RESIST: Evaluating the Effects of Anti-smoking Inoculation Messages Among Young Adult Sexual Minority Women

July 30, 2024 updated by: Andy Tan, Abramson Cancer Center at Penn Medicine
Project RESIST is an R01 study funded by NCI focused on determining the effects of using culturally tailored inoculation approaches to increase resilience to tobacco marketing influences among young adult sexual minority women ages 18-30 and incorporates critical stakeholder inputs that support later adoption and implementation. The study team is utilizing formative research to design and pre-test anti-smoking messages and two national longitudinal online survey experiments.

Study Overview

Status

Completed

Detailed Description

This study will recruit 3000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1500) and not current smokers (n = 1500). The study will determine the effects of varying the dose (single vs. multiple), and latency (immediate vs. delayed) of showing participants inoculation anti-smoking messages on smoking and quitting intentions. The study team hypothesize that the multiple exposures (vs. single), and delayed exposure (vs. immediate) will be associated with increased resistance to marketing, reduced smoking intention, and increased quitting intention. The study team will further explore the mechanisms of inoculation effects through emotions, beliefs, and attitudes towards tobacco companies. Participants will be asked to complete a baseline survey and then will receive an anti-smoking message in varying dosages based on the condition they are assigned with a control group receiving no message. Participants will then see a pro-smoking or threat message immediately, one week, or one month late, depending on the condition they were assigned.

Study Type

Interventional

Enrollment (Actual)

2591

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 18-30
  • Woman
  • Identifies as a sexual minority (any sexual orientation other than heterosexual)
  • Lives in the United States
  • Able to take surveys in English

Exclusion Criteria:

  • Under 18 or older than 30
  • Men
  • Heterosexual
  • Lives outside the United States
  • Unable to take the survey in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Currently Smoking, No Message Condition
Participants will receive no anti-smoking messages. They will receive the threat message during the baseline survey. Outcomes will be measured before and immediately after seeing the threat message, and at 1 month.
Experimental: Currently Smoking, Single Message Immediate
Participants will receive a single anti-smoking message followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking message and threat message, immediately after seeing the threat message, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Single Message 1 Week Delay
Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Single Message 1 Month Delay
Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Single Message 1 Month Delay, Repeated Exposure
Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of a single anti-smoking message at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking message at baseline and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Three Messages Immediate
Participants will receive three anti-smoking messages, followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking messages and threat message, immediately after seeing the threat message, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Three Messages 1 Week Delay
Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Three Messages 1 Month Delay
Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Currently Smoking, Three Messages 1 Month Delay Repeat Exposure
Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of three anti-smoking messages at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking messages at baseline and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
No Intervention: Not Currently Smoking, No Message Condition
Participants will receive no anti-smoking messages. They will receive the threat message during the baseline survey. Outcomes will be measured before and immediately after seeing the threat message, and at 1 month.
Experimental: Not Currently Smoking, Single Message Immediate
Participants will receive a single anti-smoking message followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking message and threat message, immediately after seeing the threat message, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Single Message 1 Week Delay
Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Single Message 1 Month Delay
Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Single Message 1 Month Delay, Repeated Exposure
Participants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of a single anti-smoking message at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking message at baseline and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Three Messages Immediate
Participants will receive three anti-smoking messages, followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking messages and threat message, immediately after seeing the threat message, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Three Messages 1 Week Delay
Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Three Messages 1 Month Delay
Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.
Experimental: Not Currently Smoking, Three Messages 1 Month Delay Repeat Exposure
Participants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of three anti-smoking messages at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking messages at baseline and immediately after seeing the threat message at 1 month.
Anti-smoking messages will be administered online via a Qualtrics survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to Quit Smoking at Follow-up
Time Frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

We used a 4-item scale on intention to quit smoking at baseline and at follow-up (immediate, one-week and one-month) among current smokers only:

  1. I will make an effort to quit smoking in the next 30 days;
  2. I intend to quit smoking in the next 30 days;
  3. I expect to quit smoking in the next 30 days;
  4. How likely is it that you will quit smoking in the next 30 days. Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28), higher scores indicate higher intention to quit.
Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions
Intention to Purchase Cigarettes
Time Frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

The Juster scale was used to measure intention to purchase cigarettes at baseline and at one-month follow-up.

Participants were asked, "How likely are you to purchase cigarettes in the next 6 months?" Responses ranged from 0=No chance, almost no chance (1 in 100) to 10=Certain, practically certain (99 in 100).

Higher values reflect higher intention to purchase.

Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions
Susceptibility to Smoke Cigarettes
Time Frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Susceptibility to smoke cigarettes were measured using four-items:

  1. Have you ever been curious about smoking a cigarette?
  2. Do you think you will smoke a cigarette in the next year?
  3. Do you think that you will try a cigarette soon?
  4. If one of your best friends were to offer you a cigarette, would you smoke it? Responses ranged on 4-point Likert-like scales.

Responses were summed to create a scale for susceptibility to smoke cigarettes (range from 0-12). This was only measured among participants who did not currently smoke.

Higher scores indicate increased susceptibility to smoke cigarettes.

Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receptivity to Marketing
Time Frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Receptivity to marketing was measured using 2 items:

  1. Tobacco companies should have the same rights to advertise as other companies.
  2. Are you open to using or wearing something with a tobacco company logo or picture on it? Response options range from 1 (strongly agree) to 5 (strongly disagree)

The scale is a sum of the responses to these items, the scale ranges from 2 to 10, with lower scores indicating greater receptivity to marketing.

Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions
Tobacco Industry Attitudes
Time Frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Tobacco industry attitudes were measured using 3 items:

  1. I would like to see cigarette companies go out of business.
  2. I would not work for a cigarette company.
  3. How much do you like cigarette companies.

Response options for items 1 and 2 were from 1 (Strongly agree) to 5 (Strongly disagree). Response options for item 3 were from 1 (Dislike strongly) to 5 (Like strongly). Response options were summed across these 3 items to create the tobacco industry attitudes scale.

Values range from 3 to 15, with lower scores indicating stronger anti-industry sentiment.

Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions
Tobacco Industry Beliefs
Time Frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Industry beliefs were measured using 4 items:

Cigarette companies lie. Cigarette companies target teens to replace smokers who die. Cigarette companies deny that cigarettes cause cancer and other harmful diseases.

Cigarette companies deny that cigarettes are addictive.

Response options were from 1 (Strongly agree) to 5 (Strongly disagree).

Responses were summed across these 4 items to create the tobacco industry beliefs scale. Values ranges from 4 to 20, with lower scores indicating stronger anti-industry sentiment.

Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 11022 (DAIDS ES Registry Number)
  • R01CA237670 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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