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Clinical Trials/NCT04772521
NCT04772521Active, not recruitingNot Applicable

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 site in 1 country300 target enrollmentStarted: April 15, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
1
Primary Endpoint
Self-reported 7-day point prevalence quit rate

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Arms & Interventions

Intervention

Experimental

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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: 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

Intervention: Mailed nicotine replacement therapy (NRT) (Drug)

Outcomes

Primary Outcomes

Self-reported 7-day point prevalence quit rate

Time Frame: 6-month

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Wang Man-Ping

Associate Professor

The University of Hong Kong

Study Sites (1)

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