A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Prolonged Abstinence Rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)).
排除标准
- •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)
研究组 & 干预措施
Enhanced Care
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Nicorette Gum (Drug)
Enhanced Care
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Nicoderm CQ (Drug)
Enhanced Care
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Smoking Quitline Referral (Other)
Enhanced Care
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Behavioral Smoking Cessation Counseling (Behavioral)
Standard Care
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Nicorette Gum (Drug)
Standard Care
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Nicoderm CQ (Drug)
Standard Care
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
干预措施: Smoking Quitline Referral (Other)
结局指标
主要结局
Prolonged Abstinence Rates
时间窗: 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.
次要结局
- 7-day Point- Prevalence Prolonged Abstinence Rate(6-month)
- Quitline Response Rate(6-month)
- Enrollment Rate(Baseline)
- Follow-Up Rate(3-month, 6-month)
- Change in Number of Cigarettes Smoked(Baseline, 6-month)
- Questionnaire Response Rate(6-month)
- Rate of Compliance to Intervention(6-month)
研究者
David Lee, PhD
Professor
University of Miami