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NCT Number: NCT06098144

Smoking Cessation Program in the Construction Sector

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Tobacco Smoking Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicorette

Drug

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.

Tobacco Quit-line

Behavioral

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.

Brief behavioral counseling

Behavioral

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.

Intensive Behavioral Counseling

Behavioral

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.

Primary outcomes

  1. Program Effectiveness Measure in Percentage

    Time frame: 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.

  2. Program Cost-Effectiveness Measured by Number of U.S Dollars

    Time frame: Up to 4 years

    Will be measured as the difference in the number of U.S. dollars between the three programs.

  3. Program Cost-Effectiveness Measured by Quality Adjusted Life Years

    Time frame: 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 outcomes

  1. Program's Implementation- Acceptability Measured by Likert Scale

    Time frame: 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.

  2. Program's Implementation- Feasibility Measured by Likert Scale

    Time frame: 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.

  3. Program's Implementation- Sustainability Measured by Likert Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Roxana de Dios Despaux, MPH

CONTACT

[email protected]

786-317-7927

Taghrid Asfar, MD

CONTACT

[email protected]

305-243-3826

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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