Trial Outcomes & Findings for Project RESIST: Increasing Resistance to Tobacco Marketing Among Young Adult Sexual Minority Women Using Inoculation Message Approaches (NCT NCT04812795)
NCT ID: NCT04812795
Last Updated: 2023-11-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2214 participants
Primary outcome timeframe
Day 30
Results posted on
2023-11-15
Participant Flow
Participant milestones
| Measure |
Culturally Tailored (Non-smokers)
The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult sexual minority women. 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)
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.
|
Culturally Tailored (Smokers)
The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult sexual minority women. 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)
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
501
|
501
|
613
|
599
|
|
Overall Study
COMPLETED
|
407
|
401
|
492
|
476
|
|
Overall Study
NOT COMPLETED
|
94
|
100
|
121
|
123
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-smokers were not asked the questions about intentions to quit smoking.
Baseline characteristics by cohort
| Measure |
Culturally Tailored (Non-smokers)
n=501 Participants
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.
|
Non-culturally Tailored (Non-smokers)
n=501 Participants
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.
|
Culturally Tailored (Smokers)
n=613 Participants
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.
|
Non-culturally Tailored (Smokers)
n=599 Participants
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.
|
Total
n=2214 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=501 Participants
|
0 Participants
n=501 Participants
|
0 Participants
n=613 Participants
|
0 Participants
n=599 Participants
|
0 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=501 Participants
|
4 Participants
n=501 Participants
|
90 Participants
n=613 Participants
|
69 Participants
n=599 Participants
|
167 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=501 Participants
|
43 Participants
n=501 Participants
|
45 Participants
n=613 Participants
|
44 Participants
n=599 Participants
|
170 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=501 Participants
|
0 Participants
n=501 Participants
|
1 Participants
n=613 Participants
|
2 Participants
n=599 Participants
|
3 Participants
n=2214 Participants
|
|
Age, Continuous
|
23.90 years
STANDARD_DEVIATION 3.47 • n=501 Participants
|
23.7 years
STANDARD_DEVIATION 3.73 • n=501 Participants
|
24.82 years
STANDARD_DEVIATION 2.91 • n=613 Participants
|
24.77 years
STANDARD_DEVIATION 2.90 • n=599 Participants
|
24.33 years
STANDARD_DEVIATION 3.27 • n=2214 Participants
|
|
Sex/Gender, Customized
Male
|
15 Participants
n=501 Participants
|
13 Participants
n=501 Participants
|
26 Participants
n=613 Participants
|
17 Participants
n=599 Participants
|
71 Participants
n=2214 Participants
|
|
Sex/Gender, Customized
Female
|
486 Participants
n=501 Participants
|
488 Participants
n=501 Participants
|
587 Participants
n=613 Participants
|
578 Participants
n=599 Participants
|
2139 Participants
n=2214 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=501 Participants
|
0 Participants
n=501 Participants
|
0 Participants
n=613 Participants
|
4 Participants
n=599 Participants
|
4 Participants
n=2214 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=501 Participants
|
73 Participants
n=501 Participants
|
57 Participants
n=613 Participants
|
58 Participants
n=599 Participants
|
262 Participants
n=2214 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
427 Participants
n=501 Participants
|
428 Participants
n=501 Participants
|
556 Participants
n=613 Participants
|
541 Participants
n=599 Participants
|
1952 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=501 Participants
|
32 Participants
n=501 Participants
|
80 Participants
n=613 Participants
|
77 Participants
n=599 Participants
|
223 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
White
|
356 Participants
n=501 Participants
|
362 Participants
n=501 Participants
|
381 Participants
n=613 Participants
|
380 Participants
n=599 Participants
|
1479 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
More than one race
|
66 Participants
n=501 Participants
|
52 Participants
n=501 Participants
|
16 Participants
n=613 Participants
|
24 Participants
n=599 Participants
|
158 Participants
n=2214 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=501 Participants
|
8 Participants
n=501 Participants
|
0 Participants
n=613 Participants
|
3 Participants
n=599 Participants
|
14 Participants
n=2214 Participants
|
|
Intention to quit smoking
|
—
|
—
|
16.54 units on a scale
STANDARD_DEVIATION 5.83 • n=613 Participants • Non-smokers were not asked the questions about intentions to quit smoking.
|
16.35 units on a scale
STANDARD_DEVIATION 5.87 • n=599 Participants • Non-smokers were not asked the questions about intentions to quit smoking.
|
16.44 units on a scale
STANDARD_DEVIATION 5.85 • n=1212 Participants • Non-smokers were not asked the questions about intentions to quit smoking.
|
|
Intention to purchase cigarettes
|
0.47 units on a scale
STANDARD_DEVIATION 1.37 • n=501 Participants
|
0.39 units on a scale
STANDARD_DEVIATION 1.18 • n=501 Participants
|
7.42 units on a scale
STANDARD_DEVIATION 2.59 • n=613 Participants
|
7.36 units on a scale
STANDARD_DEVIATION 2.59 • n=599 Participants
|
4.24 units on a scale
STANDARD_DEVIATION 4.05 • n=2214 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: U.S. young adult sexual minority women who smoked at least one cigarette in the past 30 days as baseline.
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.
Outcome measures
| Measure |
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.
|
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.
|
Culturally Tailored (Smokers)
n=489 Participants
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.
|
Non-culturally Tailored (Smokers)
n=469 Participants
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.
|
|---|---|---|---|---|
|
Intention to Quit Smoking
|
—
|
—
|
4.814 Score on a scale
Standard Deviation 5.199
|
4.844 Score on a scale
Standard Deviation 4.966
|
PRIMARY outcome
Timeframe: Day 30Population: U.S. young adult sexual minority women who completed the follow-up survey.
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.
Outcome measures
| Measure |
Culturally Tailored (Non-smokers)
n=407 Participants
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.
|
Non-culturally Tailored (Non-smokers)
n=401 Participants
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.
|
Culturally Tailored (Smokers)
n=492 Participants
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.
|
Non-culturally Tailored (Smokers)
n=476 Participants
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.
|
|---|---|---|---|---|
|
Change in Intention to Purchase Cigarettes
|
-0.034 units on a scale
Standard Deviation 1.261
|
-0.110 units on a scale
Standard Deviation 1.050
|
-2.195 units on a scale
Standard Deviation 2.954
|
-2.313 units on a scale
Standard Deviation 2.837
|
Adverse Events
Culturally Tailored (Non-smokers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-culturally Tailored (Non-smokers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Culturally Tailored (Current Smokers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-culturally Tailored (Current Smokers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place