NCT05499520

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
2,591

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

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

August 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

August 4, 2022

Results QC Date

July 5, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Intention to Quit Smoking at Follow-up

    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: 1. I will make an effort to quit smoking in the next 30 days; 2. I intend to quit smoking in the next 30 days; 3. I expect to quit smoking in the next 30 days; 4. How likely is it that you will quit smoking in the next 30 days. Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28), higher scores indicate higher intention to quit.

    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

    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

    Susceptibility to smoke cigarettes were measured using four-items: 1. Have you ever been curious about smoking a cigarette? 2. Do you think you will smoke a cigarette in the next year? 3. Do you think that you will try a cigarette soon? 4. If one of your best friends were to offer you a cigarette, would you smoke it? Responses ranged on 4-point Likert-like scales. 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 Outcomes (3)

  • 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

    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

    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

Study Arms (18)

Currently Smoking, No Message Condition

NO INTERVENTION

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.

Currently Smoking, Single Message Immediate

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Single Message 1 Week Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Single Message 1 Month Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Single Message 1 Month Delay, Repeated Exposure

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Three Messages Immediate

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Three Messages 1 Week Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Three Messages 1 Month Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Currently Smoking, Three Messages 1 Month Delay Repeat Exposure

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, No Message Condition

NO INTERVENTION

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.

Not Currently Smoking, Single Message Immediate

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Single Message 1 Week Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Single Message 1 Month Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Single Message 1 Month Delay, Repeated Exposure

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Three Messages Immediate

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Three Messages 1 Week Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Three Messages 1 Month Delay

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Not Currently Smoking, Three Messages 1 Month Delay Repeat Exposure

EXPERIMENTAL

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.

Other: Culturally Tailored Anti-Smoking Messages

Interventions

Anti-smoking messages will be administered online via a Qualtrics survey.

Currently Smoking, Single Message 1 Month DelayCurrently Smoking, Single Message 1 Month Delay, Repeated ExposureCurrently Smoking, Single Message 1 Week DelayCurrently Smoking, Single Message ImmediateCurrently Smoking, Three Messages 1 Month DelayCurrently Smoking, Three Messages 1 Month Delay Repeat ExposureCurrently Smoking, Three Messages 1 Week DelayCurrently Smoking, Three Messages ImmediateNot Currently Smoking, Single Message 1 Month DelayNot Currently Smoking, Single Message 1 Month Delay, Repeated ExposureNot Currently Smoking, Single Message 1 Week DelayNot Currently Smoking, Single Message ImmediateNot Currently Smoking, Three Messages 1 Month DelayNot Currently Smoking, Three Messages 1 Month Delay Repeat ExposureNot Currently Smoking, Three Messages 1 Week DelayNot Currently Smoking, Three Messages Immediate

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 the survey in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Results Point of Contact

Title
Andy Tan
Organization
University of Pennsylvania

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 12, 2022

Study Start

September 21, 2022

Primary Completion

July 5, 2023

Study Completion

August 15, 2023

Last Updated

July 31, 2024

Results First Posted

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations