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

August 18, 2020 updated by: Dr. Wang Man-Ping, The University of Hong Kong

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group (subgroup A+B+C)
Personalized instant messaging (PIM) + optional cocktail interventions (OCI) + AWARD advice + referral card + warning leaflet+ COSH booklet
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 Names:
  • Ask, Warn, Advise, Refer, Do-it-again
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: Warning leaflet
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
Other Names:
  • 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 Names:
  • Smoking Cessation Service Card
Behavioral: COSH booklet
A general smoking cessation self-help booklet
Other Names:
  • 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: 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 Names:
  • 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 Names:
  • 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 Names:
  • Smoking Cessation Service Card
Behavioral: COSH booklet
A general smoking cessation self-help booklet
Other Names:
  • COSH self-help smoking cessation 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
6-month follow-up
Validated abstinence of OCI vs. RIM 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)
6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6-month follow-up
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
6-month follow-up
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
3- and 6-month follow-up
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
3- and 6-month follow-up
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
3- and 6-month follow-up
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.
3- and 6-month follow-up
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.
3- and 6-month follow-up
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
3- and 6-month follow-up
Smoking cessation service use
Time Frame: 3- and 6-month follow-up
Use of smoking cessation service
3- and 6-month follow-up
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)
3- and 6-month follow-up
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).
3- and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hong Kong Council on Smoking and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QTW 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on AWARD advice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings