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Completed

NCT Number: NCT02873377

Smoking Cessation in Hispanic Construction Workers

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Research Building University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nicorette Gum

Drug

GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)

Other names: NRT

Nicoderm CQ

Drug

GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

Other names: NRT

Smoking Quitline Referral

Other

Fax referral to the State smoking Quitline

Other names: Quitline

Behavioral Smoking Cessation Counseling

Behavioral

One time face-to-face smoking cessation counseling and follow-up phone call

Other names: Counseling

Primary outcomes

  1. Prolonged Abstinence Rates

    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.

Secondary outcomes

  1. 7-day Point- Prevalence Prolonged Abstinence Rate

    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.

  2. Enrollment Rate

    Time frame: Baseline

    Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.

  3. Quitline Response Rate

    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.

  4. Follow-Up Rate

    Time frame: 3-month, 6-month

    Follow up rate will be reported as the percentage of participants that completed their follow up visit.

  5. Questionnaire Response Rate

    Time frame: 6-month

    Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.

  6. Rate of Compliance to Intervention

    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.

  7. Change in Number of Cigarettes Smoked

    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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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