Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation
Conditions
Brief summary
The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.
Interventions
DRUGNicorette
Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.
BEHAVIORALTobacco Quit-line
The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.
BEHAVIORALBrief Behavioral Counseling
The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the "5A's" for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.
BEHAVIORALIntensive Behavioral Counseling
Participants will receive four weekly counseling sessions which include information about how to quit, challenges, and short and long-term relapse prevention. Each session will last approximately 20 minutes.
Sponsors
University of Miami
Florida Department of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Cluster-randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Company leaders: * ≥ 18 years * Involved in decision making * Willing to participate in the implementation development and evaluation Safety Managers: \- ≥ 18 years Self-identified as a safety manager or superintendent Have no plans to leave the company in the next year Speak either English or Spanish Non-cigarette smoker Willing to receive training in smoking cessation treatment Willing to deliver the smoking cessation treatment to workers Construction Workers: * Be a construction worker * ≥ 18 years * Have smoked on average 5 or more cigarettes daily for the past year * Willing to make a serious quit attempt in the next 30 days * Willing to receive treatment from the Florida Tobacco Quitline. * Planning to stay in the company for the next 6 months * Own a telephone and plan to keep it active for the next 12 months
Exclusion criteria
Safety Managers: \- Current cigarette smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Effectiveness Measure in Percentage | Up to 4 years | Will be collected as the difference in percentage of participants who quit smoking at the 12-month follow-up assessment between the three treatment groups. |
| Program Cost-Effectiveness Measured by Number of U.S Dollars | Up to 4 years | Will be measured as the difference in the number of U.S. dollars between the three programs. |
| Program Cost-Effectiveness Measured by Quality Adjusted Life Years | Up to 4 years | Will be measured by quality-adjusted life years defined as the difference in the number of years lived in perfect health between the three programs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Program's Implementation- Acceptability Measured by Likert Scale | Up to 4 years | Using the Acceptability of Intervention Measure, acceptability will be scored on a 5-point Likert scale, with higher scores indicating greater acceptability. |
| Program's Implementation- Feasibility Measured by Likert Scale | Up to 4 years | Using the Feasibility of Intervention Measure, feasibility will be scored on a 5-point Likert scale, with higher scores indicating greater feasibility. |
| Program's Implementation- Sustainability Measured by Likert Scale | Up to 4 years | Using the Intervention Sustainability Assessment Tool, sustainability will be scored on a 7-point Likert scale, with higher scores indicating greater sustainability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTaghrid Asfar, MD
tasfar@miami.edu
Outcome results
None listed