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

September 20, 2021 updated by: Dr. Wang Man-Ping, The University of Hong Kong

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

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 behaviours of participants before and after attending a smoking cessation intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 randomized controlled trial study to evaluate the effectiveness of a smoking cessation intervention to assess the subjects' smoking behaviors, knowledge on smoking and satisfaction of the smoking cessation services. The investigators are interested to know if the intervention package including health education,social media and telephone follow-up would trigger higher quit rate or other changes in smoking behaviors. The investigators will also monitor the smoking status of the subjects regularly through telephone follow-ups, understand the company's practices about smoke-free policy as well as evaluate the outcomes of the intervention.

The primary outcome of the study is to measure participated smokers' self-reported 7-day point prevalence quit rate at 26 weeks follow-ups. The secondary outcomes include participated smokers' (i) self-reported reduction rate at 52 weeks follow-ups; (ii) self-reported quit attempt at 26 and 52 weeks follow-ups; (iii) self-reported reduction rate at 26 and 52 weeks follow-ups; (iv) Engagement in social media intervention.

Data of the above outcomes will be collected through telephone interviews (follow-ups) by the investigators. Descriptive statistics will be used to measure the (1) basic info of the participants, 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. Logistic regression, linear regression and spearman correlation coefficient will be used to examine the relationships between corporates' policy in smoking cessation and the knowledge and attitudes of employers/ managerial staff. Chi square and t-test will also be used to compare the quit rates between groups and logistic regression will be used to predict quitting. Data will be entered and analyzed using IBM SPSS version 23.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
679

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hong Kong residents aged 18 or above
  • Cantonese speaker
  • Smoke at least one cigarette per day in the past 30 days
  • 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 programme(s)
  • Smokers with diagnosed psychiatric illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health talk plus intensive social media intervention

Subjects in this group will receive:

  1. General health talk;
  2. Phone follow-up/counselling service (15 - 30 minutes);
  3. Social media (intensive reminders);
  4. Regular personalized what's app interaction ( up to 2 months duration)
Behavioral: Health talk plus intensive social media intervention
Subjects in this group will receive treatments including a general health education talk about smoking cessation. Subjects will also get involved in the personalized what's app interaction (up to 2 months duration) to receive social support to quit smoking. The intervention outcomes and subjects' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
Placebo Comparator: Health talk plus less intensive social media intervention

Subjects in this group will receive:

  1. General health talk;
  2. Phone follow-up/counselling service (15 - 30 mintues);
  3. Social media ( less intensive reminders)
Behavioral: Health talk plus less intensive social media intervention
Subjects in this group will receive treatments including a general health education talk about smoking cessation but without the information of active referral to other smoking cessation services. Subjects will receive less intensive reminders via social media. The intervention outcomes and subjects' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported 7-day point prevalence quit rate
Time Frame: 26 weeks
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported 7-day point prevalence quit rate
Time Frame: 52 weeks
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
52 weeks
Self-reported reduction rate
Time Frame: 26 and 52 weeks
Smokers' who reduced tobacco use (in term of daily cigarette consumption) in the follow-up when comparing with the baseline
26 and 52 weeks
Self-reported quit attempt rate
Time Frame: 26 and 52 weeks
Smokers' who refrained from smoking for 24 hours in the 7 days preceding the follow-up
26 and 52 weeks
Engagement in social media intervention
Time Frame: 26 weeks
Self-reported engagement in social media intervention in the two groups
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lok Sin Tong Benevolent Society, Kowloon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tai Hing Lam, MD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LST SCPW P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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