Clinical trial NCT04772521: Smoking Cessation Programme in Workplaces in Hong Kong (Phase Ⅴ)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Lok Sin Tong Benevolent Society, Kowloon
First posted: 2021-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 6-month
Secondary outcomes:
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 9-,12-month
measure: Biochemical validation of smoking status
timeFrame: 6-, 9-, and 12-month
measure: Self-reported reduction cigarette rate
timeFrame: 6-, 9-, and 12-month
measure: Self-reported perceived stress
timeFrame: 6-, 9-, and 12-month
measure: Self-reported depression symptoms
timeFrame: 6-, 9-, and 12-month
measure: Self-reported anxiety symptoms
timeFrame: 6-, 9-, and 12-month
measure: Self-rated health
timeFrame: 6-, 9-, and 12-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: