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

NCT ID: NCT04772521

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

General health talk

Intervention Type BEHAVIORAL

Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.

Personalized chat-based interactions

Intervention Type BEHAVIORAL

Individual chat-based interactions last 3 months and consist of 2 parts. First part is regular message. The schedule will be adjusted according to the participants' quitting and mental health status. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using the acceptance and commitment therapy (ACT) model for smoking cessation and reliving mental health problems. The conversation is based on participants' socio-demographic characteristics, smoking habit at baseline, and updated smoking status and mental health status assessed during online conversation and the baseline questionnaire.

Phone follow-up/counselling service

Intervention Type BEHAVIORAL

The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).

Mailed nicotine replacement therapy (NRT)

Intervention Type DRUG

Full course of NRT treatment (8 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics.

Control

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

Group Type PLACEBO_COMPARATOR

General health talk

Intervention Type BEHAVIORAL

Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.

Text message

Intervention Type BEHAVIORAL

Regular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups.

Phone follow-up/counselling service

Intervention Type BEHAVIORAL

The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).

Mailed nicotine replacement therapy (NRT)

Intervention Type DRUG

Full course of NRT treatment (8 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics.

Interventions

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General health talk

Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.

Intervention Type BEHAVIORAL

Personalized chat-based interactions

Individual chat-based interactions last 3 months and consist of 2 parts. First part is regular message. The schedule will be adjusted according to the participants' quitting and mental health status. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using the acceptance and commitment therapy (ACT) model for smoking cessation and reliving mental health problems. The conversation is based on participants' socio-demographic characteristics, smoking habit at baseline, and updated smoking status and mental health status assessed during online conversation and the baseline questionnaire.

Intervention Type BEHAVIORAL

Text message

Regular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups.

Intervention Type BEHAVIORAL

Phone follow-up/counselling service

The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).

Intervention Type BEHAVIORAL

Mailed nicotine replacement therapy (NRT)

Full course of NRT treatment (8 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics.

Intervention Type DRUG

Other Intervention Names

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NRT

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lok Sin Tong Benevolent Society, Kowloon

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wang Man-Ping

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Man Ping Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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School of Nursing, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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LST SCPW P5

Identifier Type: -

Identifier Source: org_study_id