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Evaluation of a Brief Tobacco Intervention in the US Military

Primary Purpose

Tobacco Use, Tobacco Smoking, Smoking, Cigar

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BTI
Cigarette smoking military tailored pamphlet
Standard smoking cessation intervention
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use focused on measuring tobacco prevention; tobacco intervention; military; brief intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 37th Training Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

BTI + Cigarette smoking military tailored pamphlet

Cigarette smoking military tailored pamphlet

Standard smoking cessation pamphlet

Arm Description

BTI + Cigarette smoking military tailored pamphlet

Cigarette smoking military tailored pamphlet

Standard smoking cessation pamphlet

Outcomes

Primary Outcome Measures

tobacco continuous abstinence
No tobacco use at 3 month follow-up since pre-assessment

Secondary Outcome Measures

Full Information

First Posted
June 20, 2017
Last Updated
September 29, 2021
Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03196102
Brief Title
Evaluation of a Brief Tobacco Intervention in the US Military
Official Title
Evaluation of a Brief Tobacco Intervention in the US Military
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Tobacco Smoking, Smoking, Cigar, Smoking, Pipe, Smoking, Hookah, Nicotine Dependence
Keywords
tobacco prevention; tobacco intervention; military; brief intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2999 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTI + Cigarette smoking military tailored pamphlet
Arm Type
Experimental
Arm Description
BTI + Cigarette smoking military tailored pamphlet
Arm Title
Cigarette smoking military tailored pamphlet
Arm Type
Active Comparator
Arm Description
Cigarette smoking military tailored pamphlet
Arm Title
Standard smoking cessation pamphlet
Arm Type
Active Comparator
Arm Description
Standard smoking cessation pamphlet
Intervention Type
Behavioral
Intervention Name(s)
BTI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cigarette smoking military tailored pamphlet
Other Intervention Name(s)
The Airman's Guide to Remaining Tobacco Free
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard smoking cessation intervention
Other Intervention Name(s)
National Cancer Institute's Clearing the Air
Intervention Description
This booklet is a 36-page, comprehensive guide for quitting smoking with 7 pages dedicated to relapse-prevention.
Primary Outcome Measure Information:
Title
tobacco continuous abstinence
Description
No tobacco use at 3 month follow-up since pre-assessment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
37th Training Group
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32060547
Citation
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.
Results Reference
background
PubMed Identifier
26508394
Citation
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.
Results Reference
background
PubMed Identifier
31903494
Citation
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.
Results Reference
result

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Evaluation of a Brief Tobacco Intervention in the US Military

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