Clinical trial NCT02695225: Tobacco Cessation Interventions With Ohio Appalachian Smokers
Official title: Tobacco Cessation Interventions With Ohio Appalachian Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-01
Enrollment: 707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tobacco use remains a significant public health problem and is increasingly prevalent among vulnerable groups. Appalachians have a high prevalence of tobacco use and are at increased risk for tobacco-attributable diseases. The efficacy of a scientifically valid tobacco cessation treatment delivered to Appalachian smokers remains untested. Also, little is known about the association of social-contextual factors that may modify or mediate the success of an intervention. These factors may be of particular relevance among disadvantaged smokers. Geographical patterns of tobacco exposure may also influence one's ability to quit, especially in pro- tobacco regions like Appalachia. The purposes of this application are to: 1) evaluate the efficacy of a lay-led (LL) intervention in promoting long term abstinence from tobacco; and 2) examine the association between 12 month abstinence and selected individual, interpersonal, organizational, neighborhood and community, and societal factors among adult Appalachian tobacco users exposed to a tobacco cessation intervention. A third aim is exploratory and includes the characterization of activity patterns using space-time measures among adult Appalachian tobacco users exposed to a tobacco cessation intervention. Using a group randomized trial design, 707 Appalachian residents from 6 intervention and 6 control counties will be randomly assigned by county to receive the LL intervention or a control condition which includes proactive telephone counseling via the Ohio Quit Line. LL group participants will receive face-to-face counseling, supervised by a county health department nurse, and delivered by a trained lay educator. A county Extension agent will assist with recruitment and retention efforts in this project. Social-contextual factors will be assessed at a baseline interview administered to all participants. Space-time activity geographical patterns of pro- and anti-tobacco exposures, or features, will be described among selected participants in four counties during weeks 1, 6 and 12 of treatment. At end of treatment and 6 and 12 months, LL and control group participants will be reassessed for tobacco use via self-report and cotinine-validation. Secondary analyses will explore differential trends over time between the two arms of the study. In a subset of the sample, pro- and anti-tobacco exposures will be estimated during weeks 1, 6 and 12 of treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years and older
* Current self-reported use of tobacco on a daily basis
* Resident of one of the 12 participating counties
* Absence of clinical condition that contraindicates use of over-the-counter NRT, including: severe arrhythmias, severe angina, or myocardial infarction within the previous 4 weeks
* If female, non-pregnant, as confirmed by urine human chorionic gonadotropin (HCG) test

Only one member per household will be enrolled. If more than one member is interested, the member whose birthday is closest to date of enrollment will be chosen. Once 12 month data collection is completed for the participant, cessation materials/referral to the Ohio Quit Line will be offered to other interested family member(s).

Exclusion Criteria:

* Under 18 years of age
* Non-daily use of tobacco (self-reported)
* Not a resident of one of the 12 participating counties
* Presences of clinical condition that contraindicates use of over-the-counter NRT, including: severe arrhythmias, severe angina, or myocardial infarction within the previous 4 weeks
* If female, pregnant, as confirmed by urine human chorionic gonadotropin (HCG) test

Primary outcomes:
measure: Self-reported tobacco abstinence in past 7 days as confirmed by saliva cotinine concentration < 15ng/ml
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
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