- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05499520
Project RESIST: Evaluating the Effects of Anti-smoking Inoculation Messages Among Young Adult Sexual Minority Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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:
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:
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:
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cigarette Smoking Behavior
-
Virginia Polytechnic Institute and State UniversityActive, not recruitingCigarette Smoking Behavior | Smoking Behaviors | CigaretteUnited States
-
Assistance Publique - Hôpitaux de ParisActive, not recruitingSmoking Cessation | Smoking, Cigarette | Electronic CigaretteFrance
-
Maastricht University Medical CenterCompletedCigarette Smoking | Cigarette Smoking Toxicity | Smoking BehaviorNetherlands
-
Virginia Polytechnic Institute and State UniversityNational Cancer Institute (NCI); Roswell Park Comprehensive Cancer CenterNot yet recruitingCigarette Smoking BehaviorUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)Completed
-
Virginia Polytechnic Institute and State UniversityMedical University of South Carolina; National Cancer Institute (NCI)CompletedCigarette Smoking BehaviorUnited States
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); University of Pennsylvania; Food and Drug Administration...Completed
-
University of OklahomaMcMaster University; University of Georgia; University of KentuckyRecruiting
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); University of PennsylvaniaRecruitingTobacco Use | Cigarette Smoking | Cigarette Smoking BehaviorUnited States
-
Pok Oi HospitalNot yet recruitingSmoking ( Cigarette)Hong Kong
Clinical Trials on Culturally Tailored Anti-Smoking Messages
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); Dana-Farber Cancer Institute; Stanford University and other collaboratorsCompletedCigarette Smoking BehaviorUnited States
-
Washington State UniversityOptum, Inc.Completed
-
University of Colorado, DenverWashington State University; Missouri Breaks Industries Research, Inc.CompletedAlzheimer DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)Yale UniversityRecruiting
-
Erasmus University RotterdamEnrolling by invitationSustainable Healthy Eating Behaviour | Food Consumption | Sustainable Food ConsumptionIreland, United Kingdom
-
University of Missouri, Kansas CityChildren's Mercy Hospital Kansas City; University of Massachusetts, Amherst; University... and other collaboratorsRecruitingPreDiabetes | Overweight and ObesityUnited States
-
Boston UniversityNational Institute of Dental and Craniofacial Research (NIDCR)Completed
-
Abramson Cancer Center at Penn MedicineUniversity of FloridaCompletedCommunication Research | Adolescent Behavior | VapingUnited States
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)CompletedHIV Infections | Sexually Transmitted DiseasesUnited States
-
Arizona State UniversityMayo Clinic; University of ArizonaCompletedColorectal CancerUnited States