Cigarette Smoking Behavior
Conditions
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.
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.
Interventions
Anti-smoking messages that are culturally tailored for sexual minority women.
OTHERNon-culturally tailored interventions
Anti-smoking messages that are not culturally tailored for sexual minority women.
Sponsors
National Cancer Institute (NCI)
Michigan State University
Harvard School of Public Health (HSPH)
Stanford University
Dana-Farber Cancer Institute
Fenway Community Health
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Quit Smoking | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 501 |
| 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. | 501 |
| 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. | 613 |
| 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. | 599 |
| Total | 2,214 |
Baseline characteristics
| Characteristic | Non-culturally Tailored (Non-smokers) | Culturally Tailored (Smokers) | Culturally Tailored (Non-smokers) | Non-culturally Tailored (Smokers) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 23.7 years STANDARD_DEVIATION 3.73 | 24.82 years STANDARD_DEVIATION 2.91 | 23.90 years STANDARD_DEVIATION 3.47 | 24.77 years STANDARD_DEVIATION 2.9 | 24.33 years STANDARD_DEVIATION 3.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 73 Participants | 57 Participants | 74 Participants | 58 Participants | 262 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 428 Participants | 556 Participants | 427 Participants | 541 Participants | 1952 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Intention to purchase cigarettes | 0.39 units on a scale STANDARD_DEVIATION 1.18 | 7.42 units on a scale STANDARD_DEVIATION 2.59 | 0.47 units on a scale STANDARD_DEVIATION 1.37 | 7.36 units on a scale STANDARD_DEVIATION 2.59 | 4.24 units on a scale STANDARD_DEVIATION 4.05 |
| Intention to quit smoking | — | 16.54 units on a scale STANDARD_DEVIATION 5.83 | — | 16.35 units on a scale STANDARD_DEVIATION 5.87 | 16.44 units on a scale STANDARD_DEVIATION 5.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 90 Participants | 4 Participants | 69 Participants | 167 Participants |
| Race (NIH/OMB) Asian | 43 Participants | 45 Participants | 38 Participants | 44 Participants | 170 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 80 Participants | 34 Participants | 77 Participants | 223 Participants |
| Race (NIH/OMB) More than one race | 52 Participants | 16 Participants | 66 Participants | 24 Participants | 158 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 0 Participants | 3 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) White | 362 Participants | 381 Participants | 356 Participants | 380 Participants | 1479 Participants |
| Sex/Gender, Customized Female | 488 Participants | 587 Participants | 486 Participants | 578 Participants | 2139 Participants |
| Sex/Gender, Customized Male | 13 Participants | 26 Participants | 15 Participants | 17 Participants | 71 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 501 | 0 / 501 | 0 / 613 | 0 / 599 |
| other Total, other adverse events | 0 / 501 | 0 / 501 | 0 / 613 | 0 / 599 |
| serious Total, serious adverse events | 0 / 501 | 0 / 501 | 0 / 613 | 0 / 599 |
Outcome results
Primary
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.
Time frame: Day 30
Population: U.S. young adult sexual minority women who completed the follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally Tailored (Non-smokers) | Change in Intention to Purchase Cigarettes | -0.034 units on a scale | Standard Deviation 1.261 |
| Non-culturally Tailored (Non-smokers) | Change in Intention to Purchase Cigarettes | -0.110 units on a scale | Standard Deviation 1.05 |
| Culturally Tailored (Smokers) | Change in Intention to Purchase Cigarettes | -2.195 units on a scale | Standard Deviation 2.954 |
| Non-culturally Tailored (Smokers) | Change in Intention to Purchase Cigarettes | -2.313 units on a scale | Standard Deviation 2.837 |
Primary
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.
Time frame: Day 30
Population: U.S. young adult sexual minority women who smoked at least one cigarette in the past 30 days as baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Culturally Tailored (Smokers) | Intention to Quit Smoking | 4.814 Score on a scale | Standard Deviation 5.199 |
| Non-culturally Tailored (Smokers) | Intention to Quit Smoking | 4.844 Score on a scale | Standard Deviation 4.966 |