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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA242593-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups.
The purpose of the focus groups is to learn how firefighting and shift work impact smokeless tobacco use and risk perceptions related to chew or dip. Using their feedback, the study team will then develop a cessation program specifically geared towards firefighters and first responders.
The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters and first responders who wish to stop using smokeless tobacco. About 50 firefighters and first responders will take part in this program, while being randomized into either the intervention group or the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| #EnufSnuff.TXT- First Responder | Experimental | Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention |
|
| Enough Snuff Intervention | Active Comparator | Participants in this group will receive tobacco cessation materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| #EnufSnuff.TXT- First Responder | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of First Responders Recruited Who Completed a Screening Assessment | Within 3 months of the initiation of study recruitment | |
| First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm | Within 3 months of the initiation of study recruitment | |
| Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire | Study engagement defined as completing the End of Intervention Program assessment. | 30 days following the end of the 10-week intervention |
| Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire | Usefulness 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). | 30 days following the end of the 10-week intervention |
| Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire | 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). | 30 days following the end of the 10-week intervention |
| Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire | Considered 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devon Noonan, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41635441 | Derived | Noonan D, Fish LJ, Silva SG, Da Costa M, Simmons LA, Garcia Ortiz N, Swinkels C, Jung D, Severson HH, Pollak KI. #EnufSnuff.TXT-FirstResponder: a pilot randomized controlled trial of a text message intervention for smokeless tobacco cessation among First Responders. Front Public Health. 2026 Jan 19;13:1699800. doi: 10.3389/fpubh.2025.1699800. eCollection 2025. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | #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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | #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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of First Responders Recruited Who Completed a Screening Assessment | First responders recruited and screened for the study. | Posted | Count of Participants | Participants | Within 3 months of the initiation of study recruitment |
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Up to 30 days following the end of the 10-week intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | #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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devon Noonan, Ph.D. | Duke University | 919-684-3786 | devon.noonan@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2024 | Nov 20, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2023 | Oct 26, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| Enough Snuff Intervention | Behavioral | 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. |
|
| 30 days following the end of the 10-week intervention |
| Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire | Recommend 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). | 30 days following the end of the 10-week intervention |
| Number of Participants Who Quit Smokeless Tobacco Measured by Self Report | Quit was determined by the self-report response (yes or no) to the question, "In the past 7 days, have you used any dip?" | 30 days following the end of the 10-week intervention |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm | First responders who met the study eligibility criteria. | Posted | Count of Participants | Participants | Within 3 months of the initiation of study recruitment |
|
|
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| Primary | Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire | Study engagement defined as completing the End of Intervention Program assessment. | Posted | Count of Participants | Participants | 30 days following the end of the 10-week intervention |
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|
|
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| Primary | Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire | Usefulness 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). | Posted | Count of Participants | Participants | 30 days following the end of the 10-week intervention |
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| Primary | Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire | 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). | Not relevant to the Enough Snuff Intervention arm. | Posted | Count of Participants | Participants | 30 days following the end of the 10-week intervention |
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| Primary | Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire | Considered 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). | Posted | Count of Participants | Participants | 30 days following the end of the 10-week intervention |
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| Primary | Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire | Recommend 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). | Posted | Count of Participants | Participants | 30 days following the end of the 10-week intervention |
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| Primary | Number of Participants Who Quit Smokeless Tobacco Measured by Self Report | Quit was determined by the self-report response (yes or no) to the question, "In the past 7 days, have you used any dip?" | Posted | Count of Participants | Participants | 30 days following the end of the 10-week intervention |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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