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.
Smoking is the single most preventable cause of deaths in Hong Kong and the smoking
prevalence was about 11.8% (20.5% in males and 3.6% in females) in 2008. It was estimated
that smoking accounts for about one fifth of all deaths and kills about 5,700 people per
year. Smoking has been associated with serious damage to health at all ages, leading to
cancers, heart diseases, stroke, chronic lung diseases, and many other health problems. It
was estimated in 1998 that a total of US$688 million medical cost were attributed to
smoking-related diseases annually, with active smoking accounted for 77% and passive smoking
23% of the total cost. However, it is difficult for smokers to quit smoking without
assistance because smoking is addictive, and most smokers prefer to try and quit on their
own rather than seeking treatment, thus it is hard to reach those smokers who do not present
themselves for treatment. On the other hand, a previous study also indicated that high quit
rate (38%) could be achieved for those smokers who received a 6-week supply of free NRT plus
telephone counselling and self-help materials.
Consistent findings from previous studies demonstrated that social support appears to be one
of the strongest determinants of success at quitting smoking and remaining abstinent. Ward
and Klesges showed that social (family) support affects smoking outcome and may influence
readiness to quit. In a US study, family support was reported to be the most significant
predictor, compared to peer and significant-other support, on the experiential and
behavioral processes of change in a smoking cessation program for adult smokers. Similar
results were also found in a local study on the motivation to reduce smoking among smokers
who are not willing to quit. It is therefore imperative to involve a family member as the
first point of contact in the health care system regarding supporting their smoking family
members in the quitting process.
In Hong Kong, 33.6% of fathers and 2.6% of mothers smoke. Nevertheless, only 1.8% male
smokers had tried smoking cessation service and among those who had not tried any, 86.1%
reported that they would not try the service. Establishing rapport with schools and building
capacity in tobacco control in students could be a feasible way to engage smokers in tobacco
control advocacy. This could also help smokers who may not have access to services which
assists them in quitting smoking.
To fill those aforementioned gaps, in this proposed project, all primary school students and
junior forms of secondary school students are mobilized for the establishment of smoke-free
homes. They play an active role in advocating for a 'Smoke-free Environment' in their home
by nominating, encouraging and supporting their family members and relatives to quit
smoking.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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