Cigarette Smoking BehaviorRESISTNCT04812795
Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches
A study testing Culturally tailored anti-smoking messages and Non-culturally tailored interventions in people with Cigarette Smoking Behavior, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Culturally tailored anti-smoking messages and Non-culturally tailored interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,214 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Under 18 or older than 30
- Men
- Heterosexual
- Lives outside the United States
- Unable to take survey in English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stanford University
Stanford, California, 94305
About this study
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.
Read the detailed description
This study will recruit 2000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1000) and not current smokers (n=1000). The study team will randomly assign participants to a condition in which they will be exposed to either culturally tailored anti-smoking messages or non-tailored. Participants will receive these messages at baseline and 1, 2, and 3 weeks post baseline. They will be asked to complete a follow-up survey one month post baseline. Intentions to quit smoking as well as intention (among current smokers) and intention to purchase cigarettes (among current nonsmokers) will be measured at baseline and one-month post baseline.
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Culturally tailored anti-smoking messages, Non-culturally tailored interventions
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally tailored anti-smoking messagesOther
Anti-smoking messages that are culturally tailored for sexual minority women.
Non-culturally tailored interventionsOther
Anti-smoking messages that are not culturally tailored for sexual minority women.
| Study group | Role | What they receive |
|---|---|---|
| Culturally tailored (Non-smokers) | Experimental | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.
Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. Receives: Other: Culturally tailored anti-smoking messages |
| Non-culturally tailored (Non-smokers) | Active comparator | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.
Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. Receives: Other: Non-culturally tailored interventions |
| Culturally Tailored (Smokers) | Experimental | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3.
Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. Receives: Other: Culturally tailored anti-smoking messages |
| Non-culturally Tailored (Smokers) | Active comparator | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3.
Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. Receives: Other: Non-culturally tailored interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Quit Smoking
Intention to quit smoking will be measured using the Burkhalter intention to quit smoking four item scale that measures readiness to cut down or quit smoking in the next 30 days at baseline and 1 month follow-up.
Participants were asked to rate 4 statements: I will make an effort to quit smoking in the next 30 days (Unlikely to Likely); I intend to quit smoking in the next 30 days (Strongly disagree to Strongly Agree); I expect to quit smoking in the next 30 days (Definitely false to Definitely true); How likely is it that you will quit smoking in the next 30 days (Unlikely to Likely). Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28).
This will only be measured among current smokers. Lowest score is 4 and highest mean score is 28. Higher scores indicate increased intention to quit smoking within the next 30 days.
Measured: Day 30
Change in Intention to Purchase Cigarettes
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start8 Sep 2021
- Primary completion5 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking BehaviorStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Michigan State University, Harvard School of Public Health (HSPH), Stanford University, Dana-Farber Cancer Institute, Fenway Community Health
- Responsible party
- Principal investigator, Andy Tan, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812795
- Sponsor's protocol ID
- 843579
- Other IDs
- R01CA237670
- Acronym
- RESIST
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2021
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zulkiewicz BA, Chen JT, Hanby EP, Ramanadhan S, Obedin-Maliver J, Lunn MR, Scout NFN, Gordon B, Applegate J, Machado A, Viswanath K, Potter J, Liu S, Tan ASL. Anti-industry beliefs and attitudes mediate the effect of culturally tailored anti-smoking messages on quit intentions among sexual minority women. Sci Rep. 2024 Nov 15;14(1):28084. doi: 10.1038/s41598-024-78207-7.
PubMed 39543185Tan ASL, Chen JT, Keen R, Scout N, Gordon B, Applegate J, Machado A, Hanby E, Liu S, Zulkiewicz B, Ramanadhan S, Obedin-Maliver J, Lunn MR, Viswanath K, Potter J. Culturally Tailored Anti-Smoking Messages: A Randomized Trial With U.S. Sexual Minority Young Women. Am J Prev Med. 2024 May;66(5):840-849. doi: 10.1016/j.amepre.2023.12.001. Epub 2023 Dec 7.
PubMed 38065403
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches
- ClinicalTrials.gov ID
- NCT04812795
- Acronym / sponsor ID
- RESIST / 843579
- Conditions
- Cigarette Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,214 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Michigan State University, Harvard School of Public Health (HSPH), Stanford University, Dana-Farber Cancer Institute, Fenway Community Health
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will recruit 2000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1000) and not current smokers (n=1000). The study team will randomly assign participants to a condition in which they will be exposed to either culturally tailored anti-smoking messages or non-tailored. Participants will receive these messages at baseline and 1, 2, and 3 weeks post baseline. They will be asked to complete a follow-up survey one month post baseline. Intentions to quit smoking as well as intention (among current smokers) and intention to purchase cigarettes (among current nonsmokers) will be measured at baseline and one-month post baseline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
| Arm | Type | Receives |
|---|---|---|
| Culturally tailored (Non-smokers) | Experimental | Other: Culturally tailored anti-smoking messagesThe anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| Non-culturally tailored (Non-smokers) | Active comparator | Other: Non-culturally tailored interventionsThe anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
| Culturally Tailored (Smokers) | Experimental | Other: Culturally tailored anti-smoking messagesThe anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| Non-culturally Tailored (Smokers) | Active comparator | Other: Non-culturally tailored interventionsThe anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Under 18 or older than 30
- Men
- Heterosexual
- Lives outside the United States
- Unable to take survey in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally tailored anti-smoking messagesAnti-smoking messages that are culturally tailored for sexual minority women. | Other | Culturally Tailored (Smokers), Culturally tailored (Non-smokers) |
| Non-culturally tailored interventionsAnti-smoking messages that are not culturally tailored for sexual minority women. | Other | Non-culturally Tailored (Smokers), Non-culturally tailored (Non-smokers) |
Primary outcome
Intention to Quit Smoking
Time frame: Day 30
Intention to quit smoking will be measured using the Burkhalter intention to quit smoking four item scale that measures readiness to cut down or quit smoking in the next 30 days at baseline and 1 month follow-up. Participants were asked to rate 4 statements: I will make an effort to quit smoking in the next 30 days (Unlikely to Likely); I intend to quit smoking in the next 30 days (Strongly disagree to Strongly Agree); I expect to quit smoking in the next 30 days (Definitely false to Definitely true); How likely is it that you will quit smoking in the next 30 days (Unlikely to Likely). Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28). This will only be measured among current smokers. Lowest score is 4 and highest mean score is 28. Higher scores indicate increased intention to quit smoking within the next 30 days.
Change in Intention to Purchase Cigarettes
Time frame: Day 30
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39543185Zulkiewicz BA, Chen JT, Hanby EP, Ramanadhan S, Obedin-Maliver J, Lunn MR, Scout NFN, Gordon B, Applegate J, Machado A, Viswanath K, Potter J, Liu S, Tan ASL. Anti-industry beliefs and attitudes mediate the effect of culturally tailored anti-smoking messages on quit intentions among sexual minority women. Sci Rep. 2024 Nov 15;14(1):28084. doi: 10.1038/s41598-024-78207-7.
- Derived from this study: PubMed 38065403Tan ASL, Chen JT, Keen R, Scout N, Gordon B, Applegate J, Machado A, Hanby E, Liu S, Zulkiewicz B, Ramanadhan S, Obedin-Maliver J, Lunn MR, Viswanath K, Potter J. Culturally Tailored Anti-Smoking Messages: A Randomized Trial With U.S. Sexual Minority Young Women. Am J Prev Med. 2024 May;66(5):840-849. doi: 10.1016/j.amepre.2023.12.001. Epub 2023 Dec 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally tailored anti-smoking messages and Non-culturally tailored interventions in people with Cigarette Smoking Behavior, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to Quit Smoking (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04812795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.