Tobacco DependenceNCT02695225
Tobacco Cessation Interventions With Ohio Appalachian Smokers
A study testing Lay-led tobacco abstinence and Lay-led promotion of Ohio Quit Line in people with Tobacco Dependence, run by Ohio State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Lay-led tobacco abstinence and Lay-led promotion of Ohio Quit Line
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 707 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
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.
- Conditions
- Tobacco Dependence
- Being tested
- Lay-led tobacco abstinence, Lay-led promotion of Ohio Quit Line
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay-led tobacco abstinenceBehavioural
Lay-led tobacco abstinence: Each intervention visit, which lasts an average of 30 minutes, will be delivered face-to-face in a mutually agreed upon convenient location (e.g. participant's home, county extension office). All behavioral and pharmacological intervention strategies will be delivered by the lay educator, with supervision by the county nurse (assigned by county with no overlap between conditions). As recommended by the USPHS guideline, all participants will set a 'quit date' and receive identical behavioral and pharmacological treatment throughout the intervention.
Lay-led promotion of Ohio Quit LineBehavioural
Lay-led promotion of Ohio Quit Line (control condition): Each participant will be given print information about the Ohio Tobacco QUIT LINE (1-800-QUIT-NOW) and encouraged to call for proactive telephone counseling and free NRT. Proactive telephone counseling and NRT administration will be provided by a QUIT LINE counselor, using their standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Lay-led tobacco abstinence | Other | Each intervention visit, which lasts an average of 30 minutes, will be delivered face-to-face in a mutually agreed upon convenient location (e.g. participant's home, county extension office). All behavioral and pharmacological intervention strategies will be delivered by the lay educator, with supervision by the county nurse (assigned by county with no overlap between conditions). As recommended by the USPHS guideline, all participants will set a 'quit date' and receive identical behavioral and pharmacological treatment throughout the intervention. Receives: Behavioral: Lay-led tobacco abstinence |
| Lay-led promotion of Ohio Quit Line | Other | Each participant will be given print information about the Ohio Tobacco QUIT LINE (1-800-QUIT-NOW) and encouraged to call for proactive telephone counseling and free NRT. Proactive telephone counseling and NRT administration will be provided by a QUIT LINE counselor, using their standard protocol. Receives: Behavioral: Lay-led promotion of Ohio Quit Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported tobacco abstinence in past 7 days as confirmed by saliva cotinine concentration < 15ng/ml
At the 12 month time point, tobacco abstinence (past 7 days) will be assessed using self-reported data. Saliva cotinine concentration of less than 15ng/ml will confirm as abstinence.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startNov 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary Ellen Wewers, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695225
- Sponsor's protocol ID
- 2008H0298
- Other IDs
- R01CA129771
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2016
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation Interventions With Ohio Appalachian Smokers
- ClinicalTrials.gov ID
- NCT02695225
- Acronym / sponsor ID
- 2008H0298
- Conditions
- Tobacco Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lay-led tobacco abstinence | Other | Behavioral: Lay-led tobacco abstinenceEach intervention visit, which lasts an average of 30 minutes, will be delivered face-to-face in a mutually agreed upon convenient location (e.g. participant's home, county extension office). All behavioral and pharmacological intervention strategies will be delivered by the lay educator, with supervision by the county nurse (assigned by county with no overlap between conditions). As recommended by the USPHS guideline, all participants will set a 'quit date' and receive identical behavioral and pharmacological treatment throughout the intervention. |
| Lay-led promotion of Ohio Quit Line | Other | Behavioral: Lay-led promotion of Ohio Quit LineEach participant will be given print information about the Ohio Tobacco QUIT LINE (1-800-QUIT-NOW) and encouraged to call for proactive telephone counseling and free NRT. Proactive telephone counseling and NRT administration will be provided by a QUIT LINE counselor, using their standard protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lay-led tobacco abstinenceLay-led tobacco abstinence: Each intervention visit, which lasts an average of 30 minutes, will be delivered face-to-face in a mutually agreed upon convenient location (e.g. participant's home, county extension office). All behavioral and pharmacological intervention strategies will be delivered by the lay educator, with supervision by the county nurse (assigned by county with no overlap between conditions). As recommended by the USPHS guideline, all participants will set a 'quit date' and receive identical behavioral and pharmacological treatment throughout the intervention. | Behavioural | Lay-led tobacco abstinence |
| Lay-led promotion of Ohio Quit LineLay-led promotion of Ohio Quit Line (control condition): Each participant will be given print information about the Ohio Tobacco QUIT LINE (1-800-QUIT-NOW) and encouraged to call for proactive telephone counseling and free NRT. Proactive telephone counseling and NRT administration will be provided by a QUIT LINE counselor, using their standard protocol. | Behavioural | Lay-led promotion of Ohio Quit Line |
Primary outcome
Self-reported tobacco abstinence in past 7 days as confirmed by saliva cotinine concentration < 15ng/ml
Time frame: 12 months
At the 12 month time point, tobacco abstinence (past 7 days) will be assessed using self-reported data. Saliva cotinine concentration of less than 15ng/ml will confirm as abstinence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lay-led tobacco abstinence and Lay-led promotion of Ohio Quit Line in people with Tobacco Dependence, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported tobacco abstinence in past 7 days as confirmed by saliva cotinine concentration < 15ng/ml (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.