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Randomized Controlled Trial
. 2018 Apr:67:47-55.
doi: 10.1016/j.cct.2018.02.007. Epub 2018 Feb 14.

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design

Taghrid Asfar  1 , Alberto J Caban-Martinez  2 , Laura A McClure  3 , Estefania C Ruano-Herreria  4 , Danielle Sierra  4 , G Gilford Clark Jr  4 , Daniel Samano  4 , Noella A Dietz  5 , Kenneth D Ward  6 , Kristopher L Arheart  4 , David J Lee  2
Affiliations
Randomized Controlled Trial

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design

Taghrid Asfar et al. Contemp Clin Trials. 2018 Apr.

Abstract

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml.

Trial registration: ClinicalTrials.gov NCT02873377.

Keywords: Cluster randomized clinical trial; Feasibly; Formative research; Smoking cessation intervention; Tailored; Worksite.

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Conflict of interest statement

DECLATION OF INTERESTS

The authors declare they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Study Design
Figure 2.
Figure 2.
The Cluster Randomization Clinical Trial Study Schema
See this image and copyright information in PMC

References

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