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临床试验/NCT04772521
NCT04772521进行中(未招募)不适用

Evaluation of a Smoking Cessation Program in Workplaces in Hong Kong: a Pragmatic Randomized Controlled Trial on Mobile Phone-Based Intervention on Smoking Cessation and Reducing Mental Health Symptoms

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Self-reported 7-day point prevalence quit rate

研究概览

简要总结

Smoking causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been a leading risk factor for death globally. Despite the availability of smoking cessation services locally, most smokers do not use such services. Workplace is one of the most convenient platforms to provide smoking cessation services and over 55% of smokers are employed according to the local population-based survey. Moreover, The COVID-19 pandemic and new normal increase in mental health burden to people in the workplace. An online survey during the pandemic found 88% of Hong Kong employees suffered from stress at work during the past 7 days. Mental health can be both precursors and consequences of smoking. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the mental health support for smoking employees in promoting smoking cessation is not clear. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention on reducing mental health symptoms and smoking cessation in workplaces in Hong Kong; identify facilitators and barriers of successful policy implementation and quitting; examine and evaluate the company environment and their policies in promoting smoking cessation.

详细描述

This study will separate into two phases. Phase I is a large scale cross-sectional survey of corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting SC in the workplace. Phase II is a 2-arm randomized controlled trial that will be conducted to examine the effectiveness of mobile phone-based intervention combined with company health talk, brief phone counselling and nicotine replacement therapy sampling, for SC in workplaces.

Data analyses

Phase I:

Descriptive statistics will be used to analyze the (1) profile of the corporations, including the total number of employees and smoking employees; (2) employers/managerial staff's knowledge on smoking; (3) employers/managerial staff's attitudes on smoking cessation; (4) practices of the companies with respect to smoking cessation.

Phase II:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 cigarette per day or use e-cigarette (EC) or heated tobacco product (HTP) daily
  • PSS-4 score ≥ 6, or GAD-2 score≥ 3, or PHQ-2 score≥ 3
  • Able to communicate in Cantonese/Mandarin and read Chinese
  • Able to use instant messaging tool (e.g. WhatsApp) for communication.
  • Stay in Hong Kong during the intervention and follow-up periods (12 months)

排除标准

  • Smokers who are psychologically or physically unable to communicate
  • Currently following other smoking cessation program(s)
  • Smokers who have severe mental illness

研究组 & 干预措施

Intervention

Experimental

Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group

干预措施: General health talk (Behavioral)

Intervention

Experimental

Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group

干预措施: Personalized chat-based interactions (Behavioral)

Intervention

Experimental

Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group

干预措施: Phone follow-up/counselling service (Behavioral)

Intervention

Experimental

Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group

干预措施: Mailed nicotine replacement therapy (NRT) (Drug)

Control

Placebo Comparator

Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group

干预措施: General health talk (Behavioral)

Control

Placebo Comparator

Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group

干预措施: Text message (Behavioral)

Control

Placebo Comparator

Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group

干预措施: Phone follow-up/counselling service (Behavioral)

Control

Placebo Comparator

Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group

干预措施: Mailed nicotine replacement therapy (NRT) (Drug)

结局指标

主要结局

Self-reported 7-day point prevalence quit rate

时间窗: 6-month

Smokers who did not smoke even a puff in the 7 days preceding the follow-up

次要结局

  • Self-reported anxiety symptoms(6-, 9-, and 12-month)
  • Self-reported 7-day point prevalence quit rate(9-,12-month)
  • Self-rated health(6-, 9-, and 12-month)
  • Self-reported perceived stress(6-, 9-, and 12-month)
  • Self-reported depression symptoms(6-, 9-, and 12-month)
  • Self-reported reduction cigarette rate(6-, 9-, and 12-month)
  • Biochemical validation of smoking status(6-, 9-, and 12-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wang Man-Ping

Associate Professor

The University of Hong Kong

研究点 (1)

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