Phase 4
N=134
Smoking Cessation in Hispanic Construction Workers
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT02873377 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Prolonged Abstinence Rates — 36.00; 30.43 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicorette Gum (Drug); Nicoderm CQ (Drug); Smoking Quitline Referral (Other); Behavioral Smoking Cessation Counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prolonged Abstinence Rates |
36.00; 30.43 | — |
| SECONDARY 7-day Point- Prevalence Prolonged Abstinence Rate |
36.00; 30.43 | — |
| SECONDARY Enrollment Rate |
85.9; 85.9 | — |
| SECONDARY Quitline Response Rate |
49.2; 40.6; 29.23; 23.19; 23.08; 11.59 | — |
| SECONDARY Follow-Up Rate |
66.15; 68.12; 76.92; 66.67 | — |
| SECONDARY Questionnaire Response Rate |
93.85; 88.41; 76.92; 66.67 | — |
| SECONDARY Rate of Compliance to Intervention |
43.08; 88.40; 93.85; 88.41; 6.15; 2.9 | — |
| SECONDARY Change in Number of Cigarettes Smoked |
-13.5; -11.5 | — |
Summary
Construction workers have the highest rate of smoking among all occupations, and are frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with smoking to increase their health risks. Minority construction workers, in particular, have higher smoking and lower cessation rates compared to other groups, and they generally show lower access and participation in cessation and health promotion services. The number of Hispanic workers employed in the construction industry in the US has tripled in the past decade to 2.6 million (23% of all construction workers). This study will develop, administer, and evaluate a novel smoking cessation program in a hard-to-reach and underserved population of Hispanic male construction workers using using pilot cluster randomized clinical trial (RCT) to test the developed intervention for feasibility and potential efficacy.
Eligibility Criteria
Inclusion Criteria
- Hispanic
- Construction worker
- Have smoked ≥ 5 cigarettes/day in the past year.
- Have access to telephone
- Have no plans to move in the next six months
- Are interested in making a serious quit attempt in the next 30 days
- Have no contraindication to NRT (e.g., history of hypersensitivity to nicotine, recent (past month) myocardial infarction, any history of serious arrhythmias or unstable angina pectoris, chronic dermatological disorder (e.g., psoriasis)).
Exclusion Criteria
- Inability to understand consent procedures
- Not Hispanic
- Not a construction worker
- Haven't smoked ≥ 5 cigarettes/day in the past year.
- No access to telephone
- Has plans to move in the next six months
- Not interested in making a serious quit attempt in the next 30 days
- Has a contraindication to NRT
- Has a generalized chronic dermatological disorder (e.g., psoriasis)
Data sourced from ClinicalTrials.gov (NCT02873377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.