NCT02873377

Smoking Cessation in Hispanic Construction Workers

A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

A two-arm, cluster-randomized controlled trial will be conducted with up to 15 construction sites, selected from one Construction Company in south Florida. Cluster randomization is used with construction site chosen as the unit of allocation because it is most practical in this setting and minimizes the risk of spillover effects from the intervention to the control group. In conjunction with the site's safety manager, the investigators will recruit 9 adult Hispanic construction workers per site (126 total) who smoke ≥5 cigarettes/day in the last year. Participants in the enhanced care will receive one culturally adapted brief face-to-face behavioral counseling session developed in phase 1 and delivered at a lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida quitline (QL), and provision of up to 6 weeks of free NRT. Participants in the standard care will receive fax referral to the Florida QL, and provision of up to 8 weeks of free NRT.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicorette Gum	GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
DRUG	Nicoderm CQ	GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
OTHER	Smoking Quitline Referral	Fax referral to the State smoking Quitline
BEHAVIORAL	Behavioral Smoking Cessation Counseling	One time face-to-face smoking cessation counseling and follow-up phone call

Timeline

• Start date: 2017-04-13
• Primary completion: 2018-10-11
• Completion: 2018-10-11
• First posted: 2016-08-19
• Last updated: 2019-11-07
• Results posted: 2019-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study