Smoking Cessation Programme in Workplaces in Hong Kong (Phase Ⅴ)

Not Applicable

Active, not recruiting

• Conditions: Smoking Cessation
• Interventions: Behavioral: General health talk; Behavioral: Personalized chat-based interactions; Behavioral: Text message; Behavioral: Phone follow-up/counselling service; Drug: Mailed nicotine replacement therapy (NRT)

• Registration Number: NCT04772521
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

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:

Primary outcome is self-reported abstinence in the past 7 days at 6-month follow-up. Secondary outcomes for smoking cessation include self-reported abstinence in the past 7 days at 9- and 12-month follow-ups, the biochemically validated abstinence (defined as exhaled CO level \<4ppm and saliva cotinine level ≤30 ng/ml); smoking reduction (50% or above reduction in cigarette consumption compared with baseline. Secondary outcomes for mental health include stress (Perceived Stress Scale-10), depression (Personal Health Questionnaire for Depression), anxiety (Generalized Anxiety Disorder scale) and self-rated health.

Descriptive statistics such as frequency, percentage, and mean will be used to summarize the outcomes and other variables. Chi-square tests and t-tests will be used to compare outcome variables between subgroups. The intention-to-treat (ITT) analysis will be used such that those lost to contact and refused cases at the follow-ups will be treated as no reduction in cigarette consumption nor quitting. Multiple imputations will be used to compute missing data for outcome variables. The association between intervention adherence (e.g., engagement in the IM interaction) and the primary outcome within the participants in the intervention group will be examined. The intervention effect by subgroups will be assessed respectively, including sex, age, education level, company types, previous quit attempts, cigarette dependence, and intention to quit, although the statistical power would be lower due to smaller numbers.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Study Start: 2021-04-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-08
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Mailed nicotine replacement therapy (NRT)	Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group
Control	Phone follow-up/counselling service	Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group
Intervention	Personalized chat-based interactions	Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group
Control	General health talk	Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group
Intervention	Phone follow-up/counselling service	Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group
Control	Mailed nicotine replacement therapy (NRT)	Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group
Intervention	General health talk	Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group
Control	Text message	Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group

Primary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence quit rate	6-month	Smokers who did not smoke even a puff in the 7 days preceding the follow-up

Secondary Outcome Measures

Name	Time	Method
Self-reported anxiety symptoms	6-, 9-, and 12-month	Anxiety will be assessed by Generalized Anxiety Disorder-2 (GAD-2). The GAD-2 is a very brief and easy to perform initial screening tool for generalized anxiety. A GAD-2 score ranges from 0-6. If the score is 3 or greater, generalized anxiety disorder is likely.
Self-reported 7-day point prevalence quit rate	9-,12-month	Smokers who did not smoke even a puff in the 7 days preceding the follow-up
Self-rated health	6-, 9-, and 12-month	Self-rated health will be measured as a single-item with the response items "excellent," "very good," "good," "fair," or "poor."
Self-reported perceived stress	6-, 9-, and 12-month	Stress will be assessed by Perceived Stress Scale-4 (PSS-4). It reports perceived stress in the past month on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Individual scores on the PSS can range from 0 to 16 with higher scores indicating higher perceived stress.
Self-reported depression symptoms	6-, 9-, and 12-month	Depression will be assessed by Personal Health Questionnaire for Depression-2 (PHQ-2). The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. A PHQ-2 score ranges from 0-6. If the score is 3 or greater, major depressive disorder is likely.
Self-reported reduction cigarette rate	6-, 9-, and 12-month	smoking reduction (50% or above reduction in cigarette consumption compared with baseline).
Biochemical validation of smoking status	6-, 9-, and 12-month	Biochemically validated quit rate (saliva cotinine level and exhale carbon monoxide test)

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong