Smoking Cessation Program in the Construction Sector
- Conditions
- Smoking CessationTobacco Use CessationTobacco Smoking
- Interventions
- Drug: Nicoderm C-Q GumBehavioral: Tobacco Quit-lineBehavioral: Intensive Behavioral CounselingBehavioral: Brief Behavioral Counseling
- Registration Number
- NCT06098144
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 608
Company leaders:
- ≥ 18 years
- Involved in decision making
- Willing to participate in the implementation development and evaluation
Safety Managers:
- ≥ 18 years
- Be a safety manager
- No plans to leave the company within the next year
- Bilingual
- 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
- 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
Safety Managers:
- Current cigarette smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Behavioral Counseling Group Nicoderm C-Q Gum Participants will receive one brief behavioral counseling session and be followed up for 12 months. Brief Behavioral Counseling Group Brief Behavioral Counseling Participants will receive one brief behavioral counseling session and be followed up for 12 months. Tobacco Quit-line (TQL) Group Tobacco Quit-line Participants will be referred to the TQL and will be followed up for up to 12 months. Brief Behavioral Counseling Group Tobacco Quit-line Participants will receive one brief behavioral counseling session and be followed up for 12 months. Intensive Behavioral Counseling Group Intensive Behavioral Counseling Participants will receive four behavioral counseling sessions and be followed up for 12 months. Intensive Behavioral Counseling Group Nicoderm C-Q Gum Participants will receive four behavioral counseling sessions and be followed up for 12 months.
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Don Soffer Clinical Research Center
🇺🇸Miami, Florida, United States