Comparative Effectiveness Research Clinical Trial
Official title:
Promoting Smoking Cessation in the Community Via Quit to Win Contest 2012: Aa Cluster Randomized Controlled Trial of 18 Districts in Hong Kong
Verified date | July 2013 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Ethics Committee |
Study type | Interventional |
Background According to the report of Census & Statistics Department, there are still
659,300 daily smokers (11.1%) in Hong Kong and smoking kills over 7,000 people per year. The
Quit and Win programme provided another opportunity to reach large group of smokers, and it
aims to widespread quit attempts among smokers via incentives in order to boost up the
number of quitters. Although such competitions appear to reach large cohorts of smokers,
there is still insufficient evidence of its effectiveness in helping smokers to achieve
complete cessation.
Aim This project aims to promote and evaluate community-based smoking cessation services
through the Quit to Win Contest organised in the 18 districts of Hong Kong. The specific
objectives of the study are (1) to build capacity in the community on smoking cessation
through a training programme; (2) to empower the participated NGOs (a) to raise the
awareness of smoking cessation in the community level; (b) to reach as many smokers as
possible; (c) to arouse the interest of smokers to quit, through organizing the Quit to Win
Contest; (3) to test the effectiveness of community-based on-site face-to-face counselling
and Short Message Service (SMS) message vs. self-help booklet to assist current smokers to
quit smoking; and (4) to build-up a community-based participatory research (CBPR) model in
smoking cessation intervention at a district level in Hong Kong.
Methods A community-based participatory (CBP) approach, which is an effective way to engage
public health researchers and community members (NGOs, other major stakeholders, and
participants), will be used. Two domains of outcome will be assessed: (1) Effectiveness of
smoking cessation interventions, (2) process evaluation of the recruitment activities
including number of eligible participants and amount of publicity.
Procedure At the recruitment sites, after screening for eligibility of participants for the
Quit to Win Contest, smoking counselor will measure eligible participant's level of carbon
monoxide (CO) on expired air, and provide the self-help smoking cessation materials
developed by the Hong Kong Council on Smoking and Health (COSH). Then the counselor will
explain and invite the participants to join the cluster randomized controlled trial on
smoking cessation intervention. Participants will be allocated to one of the groups of the
smoking cessation intervention. 3- and 6-month follow-ups will be conducted
Hypothesis 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 (with the self-help materials only). Another hypothesis to be tested is that
the intervention of sending SMS messages of smoking cessation advice is effective to
increase the quit rate comparing to the control group.
Status | Completed |
Enrollment | 1193 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Hong Kong residents aged 18 or above - Smoke at least 1 cigarette per day in the past 3 months - Able to communicate in Cantonese and read Chinese - Have a local network mobile phone - Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer Exclusion Criteria: - Smokers who have difficulties (either physical or cognitive condition) to communicate - Currently following other forms of smoking cessation programme |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The University of Hong Kong | Hong Kong SAR |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The self-reported 7-day point prevalence (pp) quit rate of smoking at 3 months | Whether the participant has quitted smoking in the past seven days at the time point of 3 months | Three months | No |
Secondary | Biochemical validated and self-reported smoking habit at 3 and 6 months | Test the cotinine level in the saliva provided by the participants Self-reported quit rate at 6 months Rate of smoking reduction by at least of half Number of quit attempts at 3 and 6 months |
3 and 6 months after recruitment | No |
Secondary | Service output of the community-based smoking cessation intervention | Assessed by a Process Evaluation onsite observation form, and a series of checklists including participants record list, proposal and final report from NGOs. The components of process evaluation, including context, reach, dose delivered, dose received, fidelity and recruitment will be assessed. | Whole project | No |
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