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
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.
According to the report of Census & Statistics Department (2011a), there are still 659,300
daily smokers (11.1%) in Hong Kong and smoking kills over 7,000 people per year (Lam et al.,
2001). Smoking also led to an annual medical cost, long-term care and productivity loss of
US$688 million in 1998 (McGhee et al., 2006), which was equivalent to 0.6% of GDP in the
region (Census & Statistics Department, 2011b). Smoking is addictive, and it is difficult
for motivated smokers to quit without assistance. On the other hand, many smokers may not be
ready to quit or wanted to quit on their own, and it is difficult to reach them.
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 (Cahill & Perera, 2011). 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 (Cahill & Perera, 2009).
In 2009, we conducted a 3-armed randomized controlled trial to compare the effectiveness of
two additional interventions of a 3-minute brief telephone advice (TEL group) and 8 of SMS
messages (SMS group) to the usual care of smoking cessation self-help material (Control
group) in the Quit to Win Contest 2009 [cite the final report]. More than one thousand
participants were successfully recruited in a period of 2 months, with an overall
self-reported quit rate of 21.6% among the contestants. However, no statistical significant
evidence was found for the additional brief telephone advice or the SMS messages in
increasing the quit rate. In 2010, we conducted another RCT on the Quit to Win Contest 2010
to compare the effectiveness of an on-site face-to-face brief smoking cessation advice vs.
self-help materials (control) to achieve quit rate and changes in smoking behaviors. Once
again, we recruited over one thousand participants during a period of 2.5 months. A higher
quit rate was observed in the intervention group (18.4%) than the control group (13.8%) at
6-month follow-up, although it was marginally statistical insignificant (p = 0.08) (Wong et
al., 2012). To conclude, both Quit to Win Contests in Hong Kong have successfully reached
and captured the interest of a large number of smokers in the community who otherwise may
not even think about quitting smoking. On the other hand, additional smoking cessation
interventions seem to boost up the quit rate among smokers who joined the Quit to Win
contest, and a dose-response relationship may appear among the additional interventions.
The theory of The Health Action Process Approach (HAPA) suggests that one's intention of
behaviour change can be fostered by knowing that the new behaviour has positive outcomes as
opposed to the negative outcomes that accompany the current behaviour; and planning (action
planning and coping planning) serves as an operative mediator between intentions and
behaviour (Schwarzer, 2008). Previous evidence has shown the applicability of the HAPA in
changing people's health behaviours, e.g., physical exercise, breast self-examination, seat
belt use, dietary behaviours, and dental flossing; and its generalizability has been
confirmed by Schwarzer (2008). A theory-based health education card (pocket size), which was
guided by the HAPA, will be developed and distributed to the participants as a reminder and
like a 'homework assignment' to be completed at home, for the purpose of enhancing their
intention and practice of the suggested behaviour (quitting smoking).
Short-Message Service (SMS) is one of the new methods of communication in the recent decade
and an expanding number of studies were conducted in 2000s since it is in a self-help mode,
inexpensive (in terms of manpower), can be readily disseminated, and available immediately
upon request. Research evidences suggested that the SMS-delivered health intervention
(including smoking cessation) have positive short-term outcomes (Fjeldsoe et al., 2009).
Specifically, the intervention may increase the intention of quitting (Yu, 2010, Ybarra,
2011), but the use of such program was under-utilized (Andrews et al., 2012). In 2009, we
conducted a RCT to test the additional effect of 8 SMS smoking cessation advice toward
smokers who participated in a Quit to Win contest towards self-help material [cite the final
report]. Although the results did not support the additional effect of SMS smoking cessation
advice, it may due to the deficient number of SMS messages provided.
Community-Based Participatory Research (CBPR) is a partnership approach in a scientific
research that involves the collaboration among community partners and academic researchers
throughout the research process (Israel et al., 1998). It has been found effective in
enhancing community input, building community capacity, and addressing barriers to health in
study participants who have historically been underrepresented in research (Andrews et al.,
2012, Horowitz et al., 2009). Community partners have the capability of managing a great
deal of resources and manpower, and utilizing their network within the community, which are
beneficial to a scientific research involving population-based interventions. To effectively
raise the awareness of the contest and recruit as many participants as we can from the
community, working with NGOs in the 18 Hong Kong districts with a CBPR model may be one
possible way of program implementation.
The challenge of applying the CBPR model in the smoking cessation program is to equip the
staffs from NGO about the related skills and knowledge, and maintain the quality of research
process and intervention. Therefore, training programme and briefing session will be
provided to the participated NGOs for the relevant knowledge transfer. In addition, process
evaluation will be conducted throughout the recruitment and research process so that the
quality and integrity of the effort by the involved NGOs can be monitored and evaluated.
Hence, we proposed to (1) test the effectiveness of an on-site face-to-face counseling using
a theory-based health education model vs. SMS message vs. self-help materials to assist
smokers who participate in the Quit to Win Contest 2012; (2) use a Community-Based
Participatory Research (CBPR) model to build capacity and to engage community partners in
taking on this important public health issue for sustainability in the community.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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