Condition category
Mental and Behavioural Disorders
Date applied
06/07/2012
Date assigned
31/07/2012
Last edited
16/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This project aims to promote quitting smoking in the community. The specific aims are to find out how well the Quit to Win Contest works in attracting smokers to quit smoking in the community, and test the effectiveness of on-site brief smoking cessation advice on quit rate and change in smoking behaviors among smokers who join the Quit to Win Contest.

Who can participate?
Adults, who smoked at least 1 cigarette per day in the past 6 months, and able to communicate in Cantonese and read Chinese.

What does the study involve?
Participants are randomly allocated to one of two groups. We set up 20 promotional booths to publicize the Quit to Win Contest and to recruit participants in selected shopping malls in the community for about two months. Smokers were invited to visit the booth and participate in the Quit to Win Contest and study. A total of 20 sessions was planned for recruitment in the study. Each of the 20 sessions was randomly allocated to intervention or control group. All participants (including the 2 study groups and the non-study group) were followed up at 6-month after the initial recruitment. Participants reported to have stopped smoking at 6 months were invited for smoking status assessment. Biochemical validation of measuring exhaled CO and salivary cotinine levels were used for the assessment. Participants who passed the biochemical tests were offered the opportunity to enter into a lucky draw. At the end of the study, we will compare the 7-day point prevalence of abstinent from smoking and the reduced cigarette consumption by at least half, and quit attempts across the two study groups.

What are the possible benefits and risks of participating?
Since participants received a brief telephone counseling from a nurse or receiving mobile phone messages, there will be no immediate direct benefit to those taking part. There was also no potential risk to the participants.

Where is the study run from?
Daily smokers were recruited in the shopping malls of 14 districts in Hong Kong.

When is study starting and how long is it expected to run for?
The study was launched from June 2009 to August 2009.

Who is funding the study?
The Hong Kong Council of Smoking and Health, Hong Kong.

Who is the main contact?
Professor Sophia Siu Chee Chan, nssophia@hku.hk
Professor David Wong, cnwong@hku.hk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sophia Siu Chee Chan

ORCID ID

Contact details

4/F
William M.W. Mong Block
21 Sassoon Road
Pokfulam
-
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Promoting smoking cessation on the site via Quit to Win 2010: a cluster randomized trial

Acronym

Study hypothesis

The study is a cluster randomized trial to evaluate the effectiveness of an on-site brief smoking cessation advice comparing to self-help materials to smokers who join the Quit to Win Contest 2010 organized by The Hong Kong Council on Smoking and Health (COSH). The aims are to promote smoking cessation in the community, and to assess the effectiveness of minimal intervention on smoking cessation through the Quit to Win Contest. We hypothesize that the on-site brief smoking cessation advice will lead to significant increases in rates of smoking cessation in the intervention group than the control group.

The specific objectives of the study are:
1. To test the effectiveness of the on-site brief smoking cessation advice on quit rate and change in smoking behaviors among smokers who join the Quit to Win Contest
2. To evaluate the impacts of the Quit to Win Contest in attracting smokers to quit smoking.

Ethics approval

Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster, ref: UW 10-239

Study design

Cluster randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Promoting smoking cessation

Intervention

Intervention group:
Study participants who are randomized to the intervention group will receive a proactive brief smoking cessation advice from our trained smoking cessation counselor on the study site after consent. They will receive advice on quitting smoking and specific warning on the hazardous effects of smoking on health will be highlighted. A hotline number will be given to the participants if they need further help. The brief advice will last about 5 minutes. They will also receive the COSH self-help materials at the recruitment sites.

Control group:
Study participants who are randomized to the control group will not receive any quitting assistance other than the self-help materials from COSH at the recruitment sites.

Non-trial group:
For those who join the Quit to Win Contest but either refused or ineligible for the cluster trial will also receive self-help material on smoking cessation. They will not be treated as subjects of the cluster randomized trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cluster randomized trial of smoking cessation interventions:
Self-reported 7-day point prevalence (pp) quit rate at 6 months.

Process evaluation of Quit to Win Contest:
1. Number of people visited the exhibition
2. Number of leaflets distributed
3. Number of people visited the smoking cessation booth
4. Number of smoking cessation self-help materials (for example: booklets and CD ROM) distributed
5. Number of people interested to join the Quit to Win Contest
6. Number of eligible participants
7. Number of eligible participants enrolled into the Contest
8. Number of eligible participants consented to the RCT study

Secondary outcome measures

1. Biochemical validated quit rate at 6 months
2. Rate of smoking reduction by at least of half
3. Number of quit attempts at 6 months

Overall trial start date

19/06/2010

Overall trial end date

30/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hong Kong residents aged 18 or above
2. Smoke at least one cigarette per day in the past 6 months
3. Able to communicate in Cantonese and read Chinese

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

964

Participant exclusion criteria

1. Smokers who are psychologically or physically unable to communicate
2. Currently following other forms of smoking cessation programme

Recruitment start date

19/06/2010

Recruitment end date

30/08/2010

Locations

Countries of recruitment

Hong Kong

Trial participating centre

4/F, William M.W. Mong Block
-
-
Hong Kong

Sponsor information

Organisation

Hong Kong Council on Smoking and Health (Hong Kong)

Sponsor details

Unit 4402-03
44/F
Hopewell Centre
183 Queen’s Road East
Wanchai
-
-
Hong Kong

Sponsor type

Government

Website

http://www.smokefree.hk/

Funders

Funder type

Government

Funder name

Hong Kong Council on Smoking and Health (Hong Kong)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes