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

NCT04772521 | Unknown DMC

• 1 other identifier: LST SCPW P5
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Self-reported 7-day point prevalence quit rate

  9-,12-month

• Biochemical validation of smoking status

  6-, 9-, and 12-month

• Self-reported reduction cigarette rate

  6-, 9-, and 12-month

• Self-reported perceived stress

  6-, 9-, and 12-month

• Self-reported depression symptoms

  6-, 9-, and 12-month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: General health talk; Behavioral: Personalized chat-based interactions; Behavioral: Phone follow-up/counselling service; Drug: Mailed nicotine replacement therapy (NRT)

Control

PLACEBO COMPARATOR

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

Behavioral: General health talk; Behavioral: Text message; Behavioral: Phone follow-up/counselling service; Drug: Mailed nicotine replacement therapy (NRT)

Interventions

General health talk 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.

Control; Intervention

Personalized chat-based interactions 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.

Intervention

Text message BEHAVIORAL

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

Control

Phone follow-up/counselling service BEHAVIORAL

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

Control; Intervention

Mailed nicotine replacement therapy (NRT) 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.

Also known as: NRT

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Lok Sin Tong Benevolent Society, Kowloon: collaborator

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Man Ping Wang, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: April 15, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)