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

Smoking Cessation Clinical Trial

Official title:

Assessing the Corporate Environment in Promoting Tobacco Control and Evaluation of a Smoking Cessation Programme in Workplaces in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870906
• Other study ID #: LST SCPW P4
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the attitudes and practices of corporations in promoting smoking cessation are not clear. Thus, this study aims to examine the employers'/ managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace and evaluate the smoking behaviors of participants before and after attending a smoking cessation intervention.

Description:

This study will separate into two phases. Phase I is a large scale cross-sectional survey to corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplace. Phase II is a 2-arm randomized controlled trial will be conducted to examine the effectiveness of WhatsApp intervention.

Outcome:

The primary outcome of the study is to measure participated smokers' self reported 7-day point prevalence quit rate at 6-month follow-up. Secondary outcomes include participated smokers' (i) self reported 7-day point prevalence quit rate at 9- and 12-month follow-ups; (ii) self-reported reduction rate at 6-, 9- and 12-month follow-ups; (iii) self-reported quit attempt at 6-, 9- and 12-month follow-ups; (iv) change in self-efficacy towards smoking cessation at 6-, 9- and 12-month follow-ups compared with baseline.

Data analyses

Phase I:

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

Phase II:

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 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. Subgroup analyses will be conducted among the "adherence" cohort, which is classified as subjects who actively participant in the WhatsApp interaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hong Kong residents aged 18 or above

• Smoke at least one cigarette per day

• Able to communicate in Cantonese/Mandarin and read Chinese

• Able to use instant messaging tool (e.g. WhatsApp) for communication

• Stay at Hong Kong during the intervention and follow-up periods (12 months)

Exclusion Criteria:

• Smokers who are psychologically or physically unable to communicate

• Currently following other smoking cessation programme(s)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Occupational-specific health talk
Health talk will provide information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
• WhatsApp interaction
Individual WhatsApp interactions last 3-month and consist of 2 parts. First part is regular WhatsApp message. The schedule will be adjusted according to the participants' quitting status. Second part is real-time discussion intervention based on participants' socio-demographic characteristics, smoking habit at baseline and updated smoking status obtained during online conversation. At 3-month follow-up, participants who are still smoking are encouraged to join an additional 1-month online group chat moderated by a smoking cessation counselor.
• Phone follow-up/counselling service
The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).

Biological:
• Text message
Participants will receive regular text messages with similar frequency to those in the intervention group.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Lok Sin Tong Benevolent Society, Kowloon

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported 7-day point prevalence quit rate	Smokers who did not smoke even a puff in the 7 days preceding the follow-up	6-month
Secondary	Self-reported 7-day point prevalence quit rate	Smokers who did not smoke even a puff in the 7 days preceding the follow-up	9- and 12-month
Secondary	Self-reported reduction rate	Smokers' who reduced tobacco use (in term of daily cigarette consumption) in the follow-up when comparing with the baseline	6-, 9-, and 12-month
Secondary	Biochemical validation of smoking status	Biochemically validated quit rate (saliva cotinine level and exhale carbon monoxide test)	6-, 9-, and 12-month