Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches

NCT ID: NCT04812795

Last Updated: 2023-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2022-06-20

Brief Summary

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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

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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

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Cigarette Smoking Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Culturally tailored (Non-smokers)

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.

Group Type EXPERIMENTAL

Culturally tailored anti-smoking messages

Intervention Type OTHER

Anti-smoking messages that are culturally tailored for sexual minority women.

Non-culturally tailored (Non-smokers)

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.

Group Type ACTIVE_COMPARATOR

Non-culturally tailored interventions

Intervention Type OTHER

Anti-smoking messages that are not culturally tailored for sexual minority women.

Culturally Tailored (Smokers)

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.

Group Type EXPERIMENTAL

Culturally tailored anti-smoking messages

Intervention Type OTHER

Anti-smoking messages that are culturally tailored for sexual minority women.

Non-culturally Tailored (Smokers)

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.

Group Type ACTIVE_COMPARATOR

Non-culturally tailored interventions

Intervention Type OTHER

Anti-smoking messages that are not culturally tailored for sexual minority women.

Interventions

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Culturally tailored anti-smoking messages

Anti-smoking messages that are culturally tailored for sexual minority women.

Intervention Type OTHER

Non-culturally tailored interventions

Anti-smoking messages that are not culturally tailored for sexual minority women.

Intervention Type OTHER

Eligibility Criteria

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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 survey in English
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Andy Tan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39543185 (View on PubMed)

Tan 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.

Reference Type DERIVED
PMID: 38065403 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA237670

Identifier Type: NIH

Identifier Source: secondary_id

View Link

843579

Identifier Type: -

Identifier Source: org_study_id

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