Trial Outcomes & Findings for Smokeless Tobacco Cessation Intervention for Firefighters (NCT NCT05111041)
NCT ID: NCT05111041
Last Updated: 2024-12-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Within 3 months of the initiation of study recruitment
Results posted on
2024-12-13
Participant Flow
All participants were recruited using social media (i.e., Facebook). An advertising profile for the study targeted the study population (e.g., current smokeless tobacco users (chewer/dipper), at or over age 18, currently working or volunteering as a firefighter or first responder, with access to a smartphone). This was a single-site study, which used electronic consents and survey measures.
Participants were required to verify their age, location, and smokeless tobacco use when submitting their information via the advertisement. During the electronic screener survey, participants were required to verify their age, first responder status, and use of smokeless tobacco as well. If any answers were outside of the eligibility requirements, they were directed to an ineligibility notification screen in the RedCap system. Those deemed eligible proceeded to the Baseline survey.
Participant milestones
| Measure |
#EnufSnuff.TXT- First Responder
Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention and support text messages.
#EnufSnuff.TXT- First Responder: Participants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco.
|
Enough Snuff Intervention
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
#EnufSnuff.TXT- First Responder
Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention and support text messages.
#EnufSnuff.TXT- First Responder: Participants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco.
|
Enough Snuff Intervention
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Smokeless Tobacco Cessation Intervention for Firefighters
Baseline characteristics by cohort
| Measure |
#EnufSnuff.TXT- First Responder
n=30 Participants
Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention and support text messages.
#EnufSnuff.TXT- First Responder: Participants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
37.7 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
37.5 years
STANDARD_DEVIATION 9.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within 3 months of the initiation of study recruitmentPopulation: First responders recruited and screened for the study.
Outcome measures
| Measure |
Recruited First Responders
n=163 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Number of First Responders Recruited Who Completed a Screening Assessment
|
163 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 3 months of the initiation of study recruitmentPopulation: First responders who met the study eligibility criteria.
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm
|
30 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 30 days following the end of the 10-week interventionStudy engagement defined as completing the End of Intervention Program assessment.
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire
|
23 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 30 days following the end of the 10-week interventionUsefulness was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 30 days following the end of the 10-week interventionPopulation: Not relevant to the Enough Snuff Intervention arm.
Helpfulness was measured on a scale of 1-5 where 1=not at all, 2=somewhat, 3=Undecided, 4=very, 5=extremely. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) and 1=yes (very, extremely).
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days following the end of the 10-week interventionConsidered quitting was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire
|
16 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 30 days following the end of the 10-week interventionRecommend to friend was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were then dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 30 days following the end of the 10-week interventionQuit was determined by the self-report response (yes or no) to the question, "In the past 7 days, have you used any dip?"
Outcome measures
| Measure |
Recruited First Responders
n=30 Participants
First responders recruited and screened for the study.
|
Enough Snuff Intervention
n=30 Participants
Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
|
|---|---|---|
|
Number of Participants Who Quit Smokeless Tobacco Measured by Self Report
|
12 Participants
|
10 Participants
|
Adverse Events
#EnufSnuff.TXT- First Responder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enough Snuff Intervention
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