NCT04812795

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 8, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

March 9, 2021

Results QC Date

July 25, 2023

Last Update Submit

November 13, 2023

Conditions

Cigarette Smoking Behavior

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 30

Study Arms (4)

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.

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.

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.

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.

Other: Non-culturally tailored interventions

Interventions

Culturally tailored anti-smoking messagesOTHER

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

Culturally Tailored (Smokers)Culturally tailored (Non-smokers)
Non-culturally tailored interventionsOTHER

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

Non-culturally Tailored (Smokers)Non-culturally tailored (Non-smokers)

Eligibility Criteria

Age18 Years - 30 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAnyone who identifies as a woman, whether they are cisgender or transgender, would meet the gender-based eligibility requirement.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 39543185DERIVED

  • 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.

    PMID: 38065403DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Results Point of Contact

Title
Dr. Andy Tan
Organization
University of Pennsylvania
andy.tan@asc.upenn.edu
2157466546

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 24, 2021

Study Start

September 8, 2021

Primary Completion

May 5, 2022

Study Completion

June 20, 2022

Last Updated

November 15, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-11

Locations

US(2)