Clinical Research Building University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT02873377
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.
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Notify Me18 year and older
Male
Interventional
Phase 4
Miami, Florida, 33136, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Other names: NRT
GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Other names: NRT
Fax referral to the State smoking Quitline
Other names: Quitline
One time face-to-face smoking cessation counseling and follow-up phone call
Other names: Counseling
Time frame: 6-month
Prolonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of <15 ng/ml.
Time frame: 6-month
Point prevalence abstinence rates is defined as self report of not smoking; in the past 7 days not even a puff) confirmed by saliva cotinine level of <15ng/ml.
Time frame: Baseline
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
Time frame: 6-month
Quitline Response will be reported by the percentage of participants that contacted the Quitline, enrolled in the tobacco Quitline and the participants that completed at least 1 phone call from Tobacco Quitline.
Time frame: 3-month, 6-month
Follow up rate will be reported as the percentage of participants that completed their follow up visit.
Time frame: 6-month
Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.
Time frame: 6-month
Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.
Time frame: Baseline, 6-month
For the participants that did not quit, the change in number of cigarettes smoked will be reported as the number of cigarettes smoked per day at the 6 months follow up visit minus the number of cigarettes smoked per day at baseline
University of Miami
Other
A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers
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