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

Cigarette Smoking Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05499520
• Other study ID #: 11022
• Secondary ID: R01CA237670
• Status: Completed
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2591
• Est. completion date: August 15, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking Behavior

Intervention

Other:
• Culturally Tailored Anti-Smoking Messages
Anti-smoking messages will be administered online via a Qualtrics survey.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Dana-Farber Cancer Institute, Fenway Community Health, Harvard School of Public Health (HSPH), National Cancer Institute (NCI), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intention to quit smoking	Change in intention to quit smoking will be measured using the Burkhalter intention to quit smoking scale. This is a four item scale that measures readiness to cut down or quit smoking in the next 30 days. This will only be measured among current smokers. Lowest mean score is 1 and highest mean score is 7. Higher scores indicate increased intention to quit smoking.	Days 0, 30
Primary	Change in intention to purchase cigarettes	Change in intention to purchase cigarettes will be measured using the Juster single item consumer buying intention scale to measure how likely participants who are not current smokers are to purchase cigarettes. Response options range from 0 to 10 with 10 indicating a higher likelihood of purchasing cigarettes.	Days 0, 30