- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196102
Evaluation of a Brief Tobacco Intervention in the US Military
Study Overview
Status
Conditions
Detailed Description
This study builds on preliminary data from this population based on over 1,000 Airmen. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently being implemented as part of Technical Training. We found that a motivational interviewing based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant positive changes that are predictive of future tobacco use in self-reported intent to use (decreased) and self-reported perceived harm (increased), we did not obtain measures of actual tobacco resumption following the tobacco use ban in Air Force training. This study will obtain and analyze data on these measures.
Airmen will be consented in the presence of an Ombudsman and randomly assigned to either (1) BTI + The Airman's Guide to Remaining Tobacco Free at the beginning of Technical Training, (2) The Airman's Guide to Remaining Tobacco Free (no BTI), or (3) the standard smoking cessation pamphlet (no BTI). All interventions in this study are command-directed interventions provided to all Technical Training students in the 37th Training Group. Airmen who are willing to participate in the study will be consented before the administration of the brief assessment of the BTI. Immediately following the intervention, consented Airmen will receive another assessment to evaluate any immediate changes in several important cognitive constructs (e.g., perceived harm, self-efficacy, perceived behavioral control, subjective norms, attitudes, intentions). At the end of Technical Training (3 months), consented Airmen will complete a final assessment to determine tobacco abstinence.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Lackland Air Force Base, Texas, United States, 78236
- 37th Training Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants will be Active duty Air Force Technical Training students from the 37th Training Group (JBSA Lackland), who are at least 18 years old.
Exclusion Criteria:
- Individuals unable to understand the consent procedures would be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BTI + Cigarette smoking military tailored pamphlet
|
Brief Tobacco Intervention (BTI).
The group intervention was designed to include the components of effective tobacco control programs for military personnel, and specifically tailored to the Technical Training environment.
The intervention is approximately 40 minutes and delivered in a group format (e.g., groups of 50 Airmen).
The format of the BTI is meant to be interactive, utilizing the Socratic teaching style and eliciting participation through the principles of motivational interviewing.
A series of open-ended questions, reflections, and decisional balance, were used to increases motivation to remain tobacco free.
The Airmen's Guide is 5×7 inches, 46 pages, with text and color illustration.
The text covers the advantages of remaining tobacco-free after Basic Military Training, and the opportunity the ban provides to begin a lifetime without tobacco, focusing on cigarettes and smokeless tobacco.
Information is included about challenges and coping suggestions for the times that Airmen are at particular risk of smoking.
The text is supplemented by images created specifically for Airmen and designed to reinforce the messages that smoking: 1) is responsible for more fatalities than combat; 2) conveys a negative image to civilians; and 3) impedes military readiness and promotion through the ranks.
Other Names:
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Active Comparator: Cigarette smoking military tailored pamphlet
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The Airmen's Guide is 5×7 inches, 46 pages, with text and color illustration.
The text covers the advantages of remaining tobacco-free after Basic Military Training, and the opportunity the ban provides to begin a lifetime without tobacco, focusing on cigarettes and smokeless tobacco.
Information is included about challenges and coping suggestions for the times that Airmen are at particular risk of smoking.
The text is supplemented by images created specifically for Airmen and designed to reinforce the messages that smoking: 1) is responsible for more fatalities than combat; 2) conveys a negative image to civilians; and 3) impedes military readiness and promotion through the ranks.
Other Names:
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Active Comparator: Standard smoking cessation pamphlet
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This booklet is a 36-page, comprehensive guide for quitting smoking with 7 pages dedicated to relapse-prevention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tobacco continuous abstinence
Time Frame: 3 months
|
No tobacco use at 3 month follow-up since pre-assessment
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3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Fahey MC, Talcott GW, McMurry TL, Klesges RC, Tubman D, Krukowski RA, Little MA. When, How, & Where Tobacco Initiation and Relapse Occur During U.S. Air Force Technical Training. Mil Med. 2020 Jun 8;185(5-6):e609-e615. doi: 10.1093/milmed/usaa016.
- Little MA, Talcott GW, Bursac Z, Linde BD, Pagano LA, Messler EC, Ebbert JO, Klesges RC. Efficacy of a Brief Tobacco Intervention for Tobacco and Nicotine Containing Product Use in the US Air Force. Nicotine Tob Res. 2016 May;18(5):1142-9. doi: 10.1093/ntr/ntv242. Epub 2015 Oct 27.
- Little MA, Fahey MC, Klesges RC, McMurry T, Talcott GW. Evaluating the Effects of a Brief Tobacco Intervention in the US Air Force. Nicotine Tob Res. 2020 Aug 24;22(9):1569-1577. doi: 10.1093/ntr/ntaa001.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-04697-XP DoD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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