Comparative Effectiveness Research Clinical Trial
Official title:
Helping Smokers to Quit Via the Smoke-free Teen Contest 2011: A Randomized Controlled Trial
Background The home is the primary source of SHS exposure. The scientific evidence shows
that there is no risk-free level of exposure to SHS that stop smoking is the sole way to
completely eliminate the risk of SHS exposure. Although research studies indicated that
smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS
exposure, governments lack the authority to restrict smoking in homes. Therefore, parental
cessation is a more effective means to reduce the SHS exposure.
Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect
of different smoking cessation approaches through the Smoke-free Teen Contest. The specific
objectives of the study are to test the effectiveness of different smoking cessation
approaches on quit rate and change in smoking behaviours among smokers who are referred by
Hong Kong Council on Smoking and Health (COSH).
Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined
the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1)
the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months
and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and
(ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6
months.
Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH),
were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized
by COSH. Those smokers will be randomized into two groups (Intervention group and Control
group) using the clustered randomization method by school. After the clustered
randomization, the oral consent of eligible subjects were obtained to the study through
telephone interview. Intervention group will receive 1,2,3, 8-week and 6-month telephone
follow-up after baseline, while control group will only receive 6-month telephone follow-up
after baseline. Those participants who reported to have stopped smoking will be invited for
biochemical validation of smoking status at 6-month follow-up.
Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will
lead to significant increases in rates of smoking cessation in the intervention groups than
the control group.
Status | Recruiting |
Enrollment | 269 |
Est. completion date | October 2012 |
Est. primary completion date | July 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 - Able to communicate in Cantonese - Intend to quit smoking Exclusion Criteria: - Smokers who are psychologically or physically unable to communicate - Currently following other forms of smoking cessation programme - Have a previous history of allergy to NRT patch or gum |
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 at 6 months | Whether the participant has quitted smoking in the past seven days at the time point of 6 months | Six months | No |
Secondary | Biochemical validated quit rate at 6 months | Test the cotinine level in the saliva provided by the participants Rate of smoking reduction by at least of half Number of quit attempts at 6 months |
Six months | No |
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