Health TrialsbyHealthPanel

Smoking Cessation Program in the Construction Sector

ConditionsSmoking CessationTobacco Use CessationTobacco Smoking
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years

Involved in decision making

Willing to participate in the implementation development and evaluation

Be a construction worker

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

608 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase 1 Group A: Tobacco Quit-line (TQL) GroupExperimental treatment 1 intervention
Group B: Phase 1 Group B: Brief Behavioral Counseling GroupExperimental treatment 3 interventions
Group C: Phase 2 Group A: Second Tobacco Quit-line (TQL) GroupExperimental treatment 1 intervention
Group D: Phase 2 Group B: Second Brief Behavioral Counseling GroupExperimental treatment 3 interventions
Group E: Phase 2 Group A + C: TQL and Intensive Behavioral Counseling GroupExperimental treatment 3 interventions
Group F: Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling GroupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Program Effectiveness Measure in Percentage

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.

Time frame
Up to 4 years
2

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

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

Time frame
Up to 4 years
3

Program Cost-Effectiveness Measured by Quality Adjusted Life 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.

Time frame
Up to 4 years

Secondary outcomes

1

Program's Implementation- Acceptability Measured by Likert Scale

Using the Acceptability of Intervention Measure, acceptability will be scored on a 5-point Likert scale, with higher scores indicating greater acceptability.

Time frame
Up to 4 years
2

Program's Implementation- Feasibility Measured by Likert Scale

Using the Feasibility of Intervention Measure, feasibility will be scored on a 5-point Likert scale, with higher scores indicating greater feasibility.

Time frame
Up to 4 years
3

Program's Implementation- Sustainability Measured by Likert Scale

Using the Intervention Sustainability Assessment Tool, sustainability will be scored on a 7-point Likert scale, with higher scores indicating greater sustainability.

Time frame
Up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Florida Department of Health

Collaborator

Source ClinicalTrials.gov
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