Clinical trial NCT03992742: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019: Personalized Cocktail Interventions to Increase Abstinence: a Sequential, Multiple Assignment, Randomized Trial (SMART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Quit to Win
Cocktail intervention
SMART design
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Council on Smoking and Health
First posted: 2019-06-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a sequential multiple assignment randomised trial (SMART) and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Detailed description: Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking which accounts for over 7,000 deaths per year. Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP). Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.

The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support. Studies have found that 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.

We propose to use adaptive design for the QTW 2019 specifically a two-phase adaptive design, i.e., a sequential, multiple assignment, randomized trial (SMART) design. Optional cocktail cessation supports will be provided based on smokers' smoking status and preference. The supports, including multimedia messages, active referral plus financial incentive, phone counseling, social support and medications, are empirically evidence-supported and most have been used in our previous QTW interventions.

Therefore, the present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a SMART design and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Eligibility criteria: Inclusion Criteria:

* Hong Kong residents aged 18 or above
* Smoke at least 1 cigarette per day in the past 3-month
* Able to communicate in Cantonese (including reading Chinese)
* Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO Smokerlyzer.
* Intent to quit / reduce smoking
* Able to use instant messaging tool (e.g., WhatsApp, WeChat) for communication.

Exclusion Criteria:

* Smokers who have communication barrier (either physically or cognitively)
* Have participation in other smoking cessation programmes or services

Primary outcomes:
measure: Validated abstinence of PIM + OCI vs. RIM + PIM
timeFrame: 6-month follow-up
measure: Validated abstinence of OCI vs. RIM in incomplete responders
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Validated abstinence of PIM + OCI vs. RIM + PIM adjusted for potential imbalance of baseline characteristic
timeFrame: 6-month follow-up
measure: Validated abstinence of OCI vs. RIM in incomplete responders adjusted for potential imbalance of baseline characteristic
timeFrame: 6-month follow-up
measure: Validated and self-reported abstinence of OCI vs. PIM in incomplete responders
timeFrame: 3- and 6-month follow-up
measure: Validated and self-reported abstinence of PIM vs. RIM in incomplete responders
timeFrame: 3- and 6-month follow-up
measure: Validated and self-reported abstinence of PIM vs. RIM
timeFrame: 3- and 6-month follow-up
measure: PIM intervention engagement on validated and self-reported abstinence
timeFrame: 3- and 6-month follow-up
measure: OCI intervention engagement on validated and self-reported abstinence
timeFrame: 3- and 6-month follow-up
measure: Smoking reduction rate change from baseline at 3- and 6-month follow-up
timeFrame: 3- and 6-month follow-up
measure: Smoking cessation service use
timeFrame: 3- and 6-month follow-up
measure: Nicotine independence (HSI) on abstinence and intervention engagement
timeFrame: 3- and 6-month follow-up
measure: Intention to quit analyses on abstinence and intervention engagement
timeFrame: 3- and 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao SZ, Weng X, Luk TT, Wu Y, Cheung DYT, Li WHC, Tong H, Lai V, Lam TH, Wang MP. Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART). Trials. 2022 Aug 18;23(1):681. doi: 10.1186/s13063-022-06502-7.