NCT03196102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,999

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

June 20, 2017

Last Update Submit

September 29, 2021

Conditions

Keywords

tobacco prevention; tobacco intervention; military; brief intervention

Outcome Measures

Primary Outcomes (1)

  • tobacco continuous abstinence

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

    3 months

Study Arms (3)

BTI + Cigarette smoking military tailored pamphlet

EXPERIMENTAL

BTI + Cigarette smoking military tailored pamphlet

Behavioral: BTIBehavioral: Cigarette smoking military tailored pamphlet

Cigarette smoking military tailored pamphlet

ACTIVE COMPARATOR

Cigarette smoking military tailored pamphlet

Behavioral: Cigarette smoking military tailored pamphlet

Standard smoking cessation pamphlet

ACTIVE COMPARATOR

Standard smoking cessation pamphlet

Behavioral: Standard smoking cessation intervention

Interventions

BTIBEHAVIORAL

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.

BTI + Cigarette smoking military tailored pamphlet

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
BTI + Cigarette smoking military tailored pamphletCigarette smoking military tailored pamphlet

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
Standard smoking cessation pamphlet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be Active duty Air Force Technical Training students from the 37th Training Group (JBSA Lackland), who are at least 18 years old.

You may not qualify if:

  • Individuals unable to understand the consent procedures would be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

37th Training Group

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (3)

  • 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.

    PMID: 32060547BACKGROUND
  • 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.

    PMID: 26508394BACKGROUND
  • 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.

MeSH Terms

Conditions

Tobacco UseTobacco SmokingCigar SmokingPipe SmokingWater Pipe SmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSmokingSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Public Health Sciences

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

April 5, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

October 7, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations