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Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992742
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Hong Kong Council on Smoking and Health
Information provided by (Responsible Party):
Dr. Wang Man-Ping, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Initial phase: personalized instant messaging (PIM) Behavioral: Second phase: optional cocktail interventions (OCI) Behavioral: Initial phase: regular instant messaging (RIM) Behavioral: Second phase: personalized instant messaging (PIM) Behavioral: AWARD advice Behavioral: Warning leaflet Behavioral: Referral card Behavioral: COSH booklet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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)
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group (subgroup A+B+C)
Personalized instant messaging (PIM) + optional cocktail interventions (OCI) + AWARD advice + referral card + warning leaflet+ COSH booklet
Behavioral: Initial phase: personalized instant messaging (PIM)

intervention Group participants will receive three months of personalized interaction through IM Apps (e.g. WhatsApp, WeChat). Our counsellors will trigger the conversation and encourage the participants to set a quit day. A total of pre-set 26 messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. These messages covered generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and encouragement to quit and use SC services.

At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PIM (subgroup C). Incomplete responders (smokers) will be randomized to continue PIM (subgroup B) or receive OCI (subgroup A).


Behavioral: Second phase: optional cocktail interventions (OCI)
For incomplete respondents (subgroup A) randomized to OCI, the available intervention options include multi-media messages, active referral plus financial incentive, phone counseling, family/peer support and medications (NRT). Participants will be guided by cessation counsellors at 1-month follow-up telephone survey to choose any combination of OCI based on their preference. If OCI participants cannot be followed up at 1-month, they will receive multi-media messages by default.

Behavioral: AWARD advice
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
Other Name: Ask, Warn, Advise, Refer, Do-it-again

Behavioral: Warning leaflet
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
Other Name: Brief leaflet on health warning and smoking cessation

Behavioral: Referral card
The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans
Other Name: Smoking Cessation Service Card

Behavioral: COSH booklet
A general smoking cessation self-help booklet
Other Name: COSH self-help smoking cessation booklet

Experimental: Control Group (subgroup D+E+F)
Regular instant messaging (RIM) + personalized instant messaging (PIM) + AWARD advice + referral card + warning leaflet+ COSH booklet
Behavioral: Initial phase: regular instant messaging (RIM)

Participants enrolled in the Control Group will receive regular messages via IM services (e.g. WhatsApp, WeChat) since initial contact and until 3-month after baseline with a tapering schedule: 1) Baseline to 4-week (1-month): 2 times/ week (8 in total); 2) 4-week to 12-week (2- & 3-month): 1 time/week (8 in total).

SC messages will generally include benefits of SC, encouragement on abstinence and use of SC services, tips on avoiding/ handling craving and reminder of participating in telephone follow-up. A reminder to participate in the telephone follow-up will also be sent at 1-, 2-, 3- and 6-month, making up a total of 20 messages.

At the end of the initial phase (1-month), complete responders (quitters) will continue to receive RIM (subgroup F). Incomplete responders (smokers) will be second randomized to continue RIM (subgroup E) or receive PIM (subgroup D). Those who are unable to follow up at 1-month will be considered as nonresponsive to the intervention.


Behavioral: Second phase: personalized instant messaging (PIM)
For incomplete responders allocated to PIM (subgroup D), participants will receive the same intervention as the Group A delivered at the initial stage. Participants will receive two months of personalized interaction through IM application. Please refer to Intervention Group "Initial phase: personalized instant messaging (PIM)" for details.

Behavioral: AWARD advice
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
Other Name: Ask, Warn, Advise, Refer, Do-it-again

Behavioral: Warning leaflet
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
Other Name: Brief leaflet on health warning and smoking cessation

Behavioral: Referral card
The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans
Other Name: Smoking Cessation Service Card

Behavioral: COSH booklet
A general smoking cessation self-help booklet
Other Name: COSH self-help smoking cessation booklet




Primary Outcome Measures :
  1. Validated abstinence of PIM + OCI vs. RIM + PIM [ Time Frame: 6-month follow-up ]
    PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml)

  2. Validated abstinence of OCI vs. PIM in incomplete responders [ Time Frame: 6-month follow-up ]
    OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml)


Secondary Outcome Measures :
  1. Validated abstinence of PIM + OCI vs. RIM + PIM adjusted for potential imbalance of baseline characteristic [ Time Frame: 6-month follow-up ]
    PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) adjusted for potential imbalance of baseline characteristic.

  2. Validated abstinence of OCI vs. RIM in incomplete responders adjusted for potential imbalance of baseline characteristic [ Time Frame: 6-month follow-up ]
    OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) adjusted for potential imbalance of baseline characteristic

  3. Validated and self-reported abstinence of OCI vs. PIM in incomplete responders [ Time Frame: 3- and 6-month follow-up ]
    OCI (subgroup A) vs. PIM (subgroup B) in incomplete responders (those who are still smoking with 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence

  4. Validated and self-reported abstinence of PIM vs. RIM in incomplete responders [ Time Frame: 3- and 6-month follow-up ]
    PIM (subgroup D) vs. RIM (subgroup E) in incomplete responders (those who are still smoking with 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence

  5. Validated and self-reported abstinence of PIM vs. RIM [ Time Frame: 3- and 6-month follow-up ]
    PIM (subgroup B+C) vs. RIM (subgroup E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence

  6. PIM intervention engagement on validated and self-reported abstinence [ Time Frame: 3- and 6-month follow-up ]

    Difference between engagement of PIM intervention vs. no engagement of PIM intervention vs. RIM intervention on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence.

    PIM intervention include subgroup B+C+D, RIM intervention include subgroup E+F.


  7. OCI intervention engagement on validated and self-reported abstinence [ Time Frame: 3- and 6-month follow-up ]

    Difference between engagement of OCI intervention vs. no engagement of OCI intervention vs. engagement of PIM intervention vs. no engagement of PIM intervention vs. RIM intervention on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence.

    OCI intervention include subgroup A, PIM intervention include subgroup B+C+D, RIM intervention include subgroup E+F.


  8. Smoking reduction rate change from baseline at 3- and 6-month follow-up [ Time Frame: 3- and 6-month follow-up ]
    Rate of smoking reduction by at least half of baseline amount

  9. Smoking cessation service use [ Time Frame: 3- and 6-month follow-up ]
    Use of smoking cessation service

  10. Nicotine independence (HSI) on abstinence and intervention engagement [ Time Frame: 3- and 6-month follow-up ]
    Subgroup analyses of high nicotine independence vs. low nicotine independence on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence, and intervention engagement (use of PIM and/or OCI intervention)

  11. Intention to quit analyses on abstinence and intervention engagement [ Time Frame: 3- and 6-month follow-up ]
    Subgroup analyses of high intention to quit vs. low intention to quit on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence, and intervention engagement (use of OCI intervention and/or PIM intervention and/or RIM intervention).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992742


Contacts
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Contact: Man Ping Wang, PhD 852 3917 6636 mpwang@hku.hk
Contact: Xue Weng, PhD 852 3917 6304 xueweng@hku.hk

Locations
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Hong Kong
School of Nursing, The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Man Ping Wang, PhD    +852 39176636    mpwang@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Council on Smoking and Health
Investigators
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Principal Investigator: Man Ping Wang, PhD The University of Hong Kong

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Responsible Party: Dr. Wang Man-Ping, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03992742    
Other Study ID Numbers: QTW 2019
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Wang Man-Ping, The University of Hong Kong:
Smoking cessation
Quit to Win
Cocktail intervention
SMART design