An interventional study of BTI and Cigarette smoking military tailored pamphlet in Tobacco Use, Tobacco Smoking and Smoking, Cigar, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by University of Virginia · Not applicable, Interventional, and Prevention
While the military has taken steps to reduce tobacco use over the past two decades, over a quarter of new military recruits report regular tobacco use prior to enlistment. This rate is higher than the national prevalence of 21.3% of US adults. Brief health prevention programs may be particularly effective for Airmen in Technical Training, given that all Airmen have been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to tobacco. 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 in latent cognitive constructs for tobacco behavior that are highly predictive of future tobacco use in youth and young adults, the Little et al study did not obtain measures of actual tobacco resumption following the ban on tobacco in Air Force training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training, a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately 2,000 Air Force trainees at the beginning of Technical Training at Joint Base San Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation ban; (2) To randomize participants to either (a) receive our cigarette smoking military tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide; which has been disseminated and is now the standard of care in the Air Force) or (b) the Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month, end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary outcome is tobacco abstinence at the end of Technical Training to determine an estimated effect size as well as establish the requisite preliminary work for a subsequent R01. Given that over 220,000 new recruits enter the military annually in one of the service branches, the public health implications of an effective brief tobacco intervention targeting the most commonly used tobacco for military personnel in Technical Training is considerable. If the BTI is proven efficacious it can be easily disseminated to other service branches that have similar tobacco bans during Technical Training.
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.
140 studies on the registry are indexed under Tobacco Use; 68 are open to participants now.
This study's enrollment of 2,999 is above the median of 150 across 131 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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BTI + Cigarette smoking military tailored pamphlet
Behavioral: BTI · Behavioral: Cigarette smoking military tailored pamphlet
Cigarette smoking military tailored pamphlet
Behavioral: Cigarette smoking military tailored pamphlet
Standard smoking cessation pamphlet
Behavioral: Standard smoking cessation intervention
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.
Also known as: The Airman's Guide to Remaining Tobacco Free
This booklet is a 36-page, comprehensive guide for quitting smoking with 7 pages dedicated to relapse-prevention.
Also known as: National Cancer Institute's Clearing the Air
tobacco continuous abstinence
No tobacco use at 3 month follow-up since pre-assessment
Time frame: 3 months
Plan to share: No
Ran from Apr 2017 to primary completion in Jan 2018, 9 months.
Of 73 non-industry interventional studies with no phase under Tobacco Use, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's 9 months is below that.
Counting every sponsor, half of 86 studies reached it within 20 months; a quarter within 11 and three quarters within 46.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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