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Smoking CessationNCT01928251

Promoting Smoking Cessation in the Community Via Quit to Win Contest 2013

A study testing Informed early monetary incentive and Uninformed early monetary incentive in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

According to the Census \& Statistics Department (2011), there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking and passive smoking kill over 7,000 people per year. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Informed early monetary incentive and Uninformed early monetary incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,143 participants
Where
1 siteChina
Study dates
Jun 2013to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 cigarette per day in the past 3 months
  • Able to communicate in Cantonese
  • Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer

Who cannot join

  • Smokers who have difficulties (either physical or cognitive condition) to communicate
  • Currently following other smoking cessation programs

Trial locations and contacts

1 site in 1 country.

China1 site
  • The University of Hong Kong

    Hong Kong SAR

Other trials in China

About this study

Official title: Promoting Smoking Cessation in the Community Via Quit to Win Contest 2013: A Prospective Study and a Randomized Controlled Trial

According to the Census \& Statistics Department (2011), there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking and passive smoking kill over 7,000 people per year. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. On the other hand, many smokers may not be ready to quit or want to quit on their own, so it is difficult to reach them.

Quit and Win programme is an opportunity to reach and encourage a large group of smokers to make quit attempt. Quit and Win Contest assumes that smokers can develop a higher motivation to quit and gain a wider social support in quitting. According to Cahill and Petera (2011), smokers can develop a high motivation to quit and gain a wider social support through participating in the Quit and Win Contest.

Read more

The Hong Kong Council on Smoking and Health (COSH) organized three "Quit to Win Contests" and recruited over 3000 smokers from 2009-2012. These events enhanced the motivation and confidence to quit smoking. Lucky draw was also conducted to attract smokers to quit smoking and winners were validated by biochemical tests.

Community-Based Participatory Research (CBPR) is an partnership approach that can enlighten and utilize the network within communities as community partners can obtain ample manpower and social resources. 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 effective way of program implementation.

Thus, we proposed to (1) test the effectiveness of combining competition and short-term monetary incentives to motivate smokers who participate in the Quit to Win Contest 2013 to quit smoking; (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; and (3) conduct the process evaluation to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Hypothesis:

To examine the effectiveness of the interventions, three arms are (i) Group A: Informed early monetary incentive, which participants will be notified of the incentive through telephone follow-up at 1-week and 1-month follow-ups; (ii) Group B: Uninformed early monetary incentive, which participants will not be informed about the incentive until 3-month telephone follow-up; (iii) Group C (control group): Uninformed late monetary incentive, which participants will not be informed about the incentive throughout 1-week, 1-month and 3-month follow-ups.

The primary outcomes are the self-reported 7-day point prevalence (pp) quit rate at 3 months of group A compared to group B and group C. The secondary outcomes include (i) self-reported 7-day point prevalence (pp) quit rate at 6 months, (ii) biochemical validated quit rates, (iii) rate of smoking reduction by at least half of baseline amount, (iv) number of quit attempts at 3 and 6 months among the three groups and (v) the above cessation outcomes of all subjects, including or not including in the RCT.

Read the detailed description

According to the report of Census \& Statistics Department (Census \& Statistics Department (Hong Kong SAR government), 2011), there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking and passive smoking kills over 7,000 people per year (Lam, Ho, Hedley, Mak, \& Peto, 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 (Hong Kong SAR government), 2001). Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. On the other hand, many smokers may not be ready to quit or want to quit on their own, so it is difficult to reach them.

The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt, in order to increase the number of quitters. This Quit and Win model assumes that smokers can develop a higher motivation to quit and gain a wider social support in quitting thru participating in this kind of contests (Cahill \& Petera, 2011). Such quitting contests or incentive programs appeared to reach a large number of smokers, and demonstrated a significantly higher quit rate for the quit and win group than for the control group (Cahill \& Rafael, 2008). Cognitive theory suggested that immediate incentive exerts more influence than delayed reward for implementing more patient preferences (Berns, Laibson, \& Loewenstein, 2007). Some critics echoed this by considering to reward the participants who were abstinent or achieved other cessation outcomes in the early stage of the quitting process, instead of a later cessation outcome (Aveyard \& Bauld, 2011). Among the three overseas studies attempted to combine short-term monetary reward and competition as the incentive for abstinence (Glasgow, Hollis, Ary, \& Boles, 1993; Hennrikus, Jeffery, Lando, \& Murray, 2002; Koffman, Lee, Hopp, \& Emont, 1998), Koffman's study in the workplace supported that participants with short-term incentives had a higher quit rate at 6 months than others without the incentives.

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 and 8 mobile phone messages to the usual care of smoking cessation self-help material in the Quit to Win Contest 2009 (Chan, 2011). More than one thousand participants were successfully recruited in a period of one and half months, with an overall self-reported quit rate of 21.6% among the contestants. However, the additional brief telephone advice or the SMS messages did not show a higher quit rate than control group. 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 versus self-help materials (control) on 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%), in which participants received an on-site brief counselling, than the control group (13.8%) at 6-month follow-up, although it was marginally statistically insignificant (p = 0.08) (Wong \& Chan, 2012). In 2012, the RCT in the Quit to Win Contest tested the effectiveness of the on-site counselling with telephone boosters and health education card theoretically based on the Health Action Process Approach for the intervention group (Schwarzer, 2008). 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. In addition, another SMS intervention group received 16 SMS about cessation advice and motivation within one month. The quit rates for these two intervention groups were 9.4% and 11.5%, respectively, but they did not differ from the control group significantly (9.7%).

The three Quit to Win Contests in Hong Kong recruited over 3,000 smokers from the community who otherwise might not even think about quitting smoking. On the other hand, the engagement in the competition boosted up the confidence and motivation to quit among smokers who joined the Quit to Win contest, but additional counselling and short messaging services did not increase the quit rate. All the three contests conducted a lucky draw to select a few prize winners whose abstinence was validated by biochemical tests. In accordance with the research direction suggested by the above foreign studies, the forthcoming RCT on Quit to Win Contest will explore the effectiveness of short-term monetary incentives combined with the prizes of the lucky draws.

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, Schulz, \& Parker, 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, Newman, Heath, Williams, \& Tingen, 2012; Horowitz, Robinson, \& Seifer, 2009). Community partners have the capability of mobilizing local social 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 effective way of program implementation.

The challenge of applying the CBPR model in the smoking cessation program is to equip the staff from NGOs and HKU about the related skills and knowledge, and maintain the quality of research process and intervention. Process evaluation is a systematic procedure during the delivery of public health interventions in order to understand how well the program does and to link the progress to outcomes (Centers for Disease Control and Prevention, 2008). In addition to the training programme and briefing session to be provided to the participating NGOs, monitoring and documentation are needed throughout the recruitment and research process so that the quality and integrity of the effort by the involved NGOs can be evaluated.

To conclude, we proposed to (1) test the effectiveness of combining competition and short-term monetary incentives to motivate smokers who participate in the Quit to Win Contest 2013 to quit smoking; (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; and (3) conduct the process evaluation to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Being tested
Informed early monetary incentive, Uninformed early monetary incentive
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Informed early monetary incentiveBehavioural

    Participants will be informed at 1 week after the baseline recruitment about the monetary incentive of quitting.

    Apart from the different arrangement of monetary incentives for the three RCT arms, all participants of the Quit to Win Contest will receive self-help materials on smoking cessation, including a COSH-developed self-help smoking cessation booklet, a health education card, and the quitline (i.e. 1833183). The theory-based health education card (pocket size), which guided by the HAPA, will be developed and distributed to the participants as a reminder and a 'homework assignment' to be completed at home, for the purpose of enhancing their intention and practice of the suggested behaviour (quitting smoking).

  • Uninformed early monetary incentiveBehavioural

    Participants will be informed at 3 months after the baseline recruitment about the monetary incentive of quitting.

    Apart from the different arrangement of monetary incentives for the three RCT arms, all participants of the Quit to Win Contest will receive self-help materials on smoking cessation, including a COSH-developed self-help smoking cessation booklet, a health education card, and the quitline (i.e. 1833183). The theory-based health education card (pocket size), which guided by the HAPA, will be developed and distributed to the participants as a reminder and a 'homework assignment' to be completed at home, for the purpose of enhancing their intention and practice of the suggested behaviour (quitting smoking).

Study groups in NCT01928251
Study groupRoleWhat they receive
Informed early monetary incentiveExperimentalIncentives of abstinence will be given to those who self-report abstinence for the past 7 days at 3-month follow-up and pass the 3-month biochemical validation (Exhaled carbon monoxide level < 4 ppm, saliva cotinine level < 10 ng/ml) (Group A-Q). Participants will be informed about the incentives through telephone follow-up at 1 week and 1 month. Those who have not quitted at 3 months (Group A-N) or those self-reported quitters who refuse to participate in biochemical validation will be informed again that they will be given the same incentive if they have quitted at 6 months and the quitting is validated.
Receives: Behavioral: Informed early monetary incentive
Uninformed early monetary incentiveExperimentalIncentives of abstinence will be given to those who self-report abstinence for the past 7 days and pass the 3-month biochemical validation (Group B-Q), but they will not be informed about the incentive at the 1-week and 1-month follow-up. Those who have not quitted at 3 months (Group B-N) or those self-reported quitters who refuse to participate in the biochemical validation will be informed that they will be given the same incentive if they have quitted at 6 months and the quitting is validated.
Receives: Behavioral: Uninformed early monetary incentive
Uninformed late monetary incentiveNo interventionIncentives for the self-reported and biochemically-validated abstinence at 6-month follow-up will be given after the 6-month biomedical validation. They would not be informed about the incentive at the 1-week, 1-month and 3-month follow-up. Group C also has two subgroups, those who have quitted at 3 months (Group C-Q) and those who have not (Group C-N).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported quit rate

    Self-reported 7-day point prevalence quit rate after 3 months

    Measured: 3 months after recruitment

Secondary outcomes (1)
  1. Biochemically validated and self-reported smoking habit at 3 and 6 months

    (i) self-reported 7-day point prevalence (pp) quit rate at 6 months, (ii) biochemical validated quit rates, (iii) rate of smoking reduction by at least half of baseline amount, (iv) number of quit attempts at 3 and 6 months among the three groups and (v) the above cessation outcomes of all subjects, including or not including in the RCT.

    Measured: 3 and 6 months after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01928251
Sponsor's protocol ID
QTW2013
Status last verified
Jun 2014
First submitted
30 May 2013
Last updated
27 Jun 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Informed early monetary incentive and Uninformed early monetary incentive in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported quit rate (time frame: 3 months after recruitment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.

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