Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-25 @ 4:10 AM
Study NCT ID:
NCT03196102
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2017-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Brief Tobacco Intervention in the US Military
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D000073863', 'term': 'Cigar Smoking'}, {'id': 'D000073868', 'term': 'Pipe Smoking'}, {'id': 'D000073867', 'term': 'Water Pipe Smoking'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2999}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tobacco continuous abstinence', 'timeFrame': '3 months', 'description': 'No tobacco use at 3 month follow-up since pre-assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tobacco prevention; tobacco intervention; military; brief intervention'], 'conditions': ['Tobacco Use', 'Tobacco Smoking', 'Smoking, Cigar', 'Smoking, Pipe', 'Smoking, Hookah', 'Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '32060547', 'type': 'BACKGROUND', '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.'}, {'pmid': '26508394', 'type': 'BACKGROUND', '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.'}, {'pmid': '31903494', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nAirmen 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be Active duty Air Force Technical Training students from the 37th Training Group (JBSA Lackland), who are at least 18 years old.\n\nExclusion Criteria:\n\n* Individuals unable to understand the consent procedures would be excluded.'}, 'identificationModule': {'nctId': 'NCT03196102', 'briefTitle': 'Evaluation of a Brief Tobacco Intervention in the US Military', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Evaluation of a Brief Tobacco Intervention in the US Military', 'orgStudyIdInfo': {'id': '16-04697-XP DoD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTI + Cigarette smoking military tailored pamphlet', 'description': 'BTI + Cigarette smoking military tailored pamphlet', 'interventionNames': ['Behavioral: BTI', 'Behavioral: Cigarette smoking military tailored pamphlet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cigarette smoking military tailored pamphlet', 'description': 'Cigarette smoking military tailored pamphlet', 'interventionNames': ['Behavioral: Cigarette smoking military tailored pamphlet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard smoking cessation pamphlet', 'description': 'Standard smoking cessation pamphlet', 'interventionNames': ['Behavioral: Standard smoking cessation intervention']}], 'interventions': [{'name': 'BTI', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['BTI + Cigarette smoking military tailored pamphlet']}, {'name': 'Cigarette smoking military tailored pamphlet', 'type': 'BEHAVIORAL', 'otherNames': ["The Airman's Guide to Remaining Tobacco Free"], '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.", 'armGroupLabels': ['BTI + Cigarette smoking military tailored pamphlet', 'Cigarette smoking military tailored pamphlet']}, {'name': 'Standard smoking cessation intervention', 'type': 'BEHAVIORAL', 'otherNames': ["National Cancer Institute's Clearing the Air"], 'description': 'This booklet is a 36-page, comprehensive guide for quitting smoking with 7 pages dedicated to relapse-prevention.', 'armGroupLabels': ['Standard smoking cessation pamphlet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78236', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': '37th Training Group', 'geoPoint': {'lat': 29.38663, 'lon': -98.61797}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Public Health Sciences', 'investigatorFullName': 'Melissa Little, PhD, MPH', 'investigatorAffiliation': 'University of Virginia'}}}}