Study Results
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Basic Information
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COMPLETED
NA
1369 participants
INTERVENTIONAL
2016-08-17
2017-11-27
Brief Summary
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Detailed Description
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Objectives: The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018) project is to assess whether a program of widely accessed mobile phone-based text message interventions ('Happy Quit') will be effective at helping people in China who smoke, to quit. Based on the efficacy of previous studies in smoking cessation, it is hypothesized that'Happy Quit' will be an effective, feasible and affordable smoking cessation program in China.
Methods: In this single-blind, randomized trial, undertaken in China, about 2,000 smokers willing to make a quit attempt will be randomly allocated, using an independent telephone randomization system that includes a minimization algorithm balancing for sex (male, female), age (19-34 or \>34 years), educational level (≤ or \>12 years), and Fagerstrom score for nicotine addiction (≤5, \>5), to 'Happy Quit', comprising motivational messages and behavioral-change support, or to a control group that receives text messages unrelated to quitting.
Outcome measures: The primary outcome will be continuous smoking abstinence. A secondary outcome will be point prevalence of abstinence. Abstinence will be assessed by means of brief telephone interviews at six time points (4, 8, 12, 16, 20 and 24 weeks post-intervention). A third outcome will be reductions in number of cigarettes smoked per day.
Implications: The results will provide valuable insights into bridging the gap between need and services received for smoking cessation interventions and tobacco use prevention in China. It will also serve as mHealth model for extending the public health significance of other interventions, such as mental health interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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intensive cessation message
Participants who allocate to this intervention group will receive regular, personalized text messages providing smoking cessation advice, support, and distraction. A quit day will be negotiated with each participant, and one to five messages will be sent per day for the time leading up to the quit day and the following 12 weeks.
One to three messages will be sent per week until the end of the 24 week follow up. In order to measure the main two outcomes (self-reported continuous smoking abstinence and point prevalence of abstinence), continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last 4 weeks and past 1 week if they are still smoking, they will also be checked by phone call at 4, 8, 12, 16, 20, 24 week points.
intensive cessation message
Mobile phone-based text message （three to five messages per day） interventions ('Happy Quit') for smoking cessation for 12 weeks with 24 week follow up.
No cessation message intervention
Control group participants only will receive one text message every week, thanking them for being in the study, providing study center contact details, and reminding them of the time until their free month at the end of follow up. Another one to two messages will be sent per week until the end of the 24 week. In order to measure the main two outcomes (self-reported continuous smoking abstinence and point prevalence of abstinence), continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last 4 weeks and past 1 week if they are still smoking, they will also be checked by phone call at 4, 8, 12, 16, 20, 24 week points.
No interventions assigned to this group
Not intensive cessation message
Participants who allocate to this intervention group will receive regular, personalized text messages providing smoking cessation advice, support, and distraction. A quit day will be negotiated with each participant, and one to five messages will be sent per week for the time leading up to the quit day and the following 12 weeks.
One to three messages will be sent per week until the end of the 24 week follow up. In order to measure the main two outcomes (self-reported continuous smoking abstinence and point prevalence of abstinence), continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last 4 weeks and past 1 week if they are still smoking, they will also be checked by phone call at 4, 8, 12, 16, 20, 24 week points.
Not intensive cessation message
Mobile phone-based text message （three to five messages per week） interventions ('Happy Quit') for smoking cessation for 12 weeks with 24 week follow up.
Interventions
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intensive cessation message
Mobile phone-based text message （three to five messages per day） interventions ('Happy Quit') for smoking cessation for 12 weeks with 24 week follow up.
Not intensive cessation message
Mobile phone-based text message （three to five messages per week） interventions ('Happy Quit') for smoking cessation for 12 weeks with 24 week follow up.
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age and older living.
3. Being able to read and write in Chinese.
4. Owning a text-capable cell phone and knowing how to text.
5. Willing to make an attempt to quit smoking in the next month.
6. Willing to provide informed consent to participate in the study.
Exclusion Criteria
2. Below 18 years old.
3. Unable to read and write in Chinese.
18 Years
ALL
Yes
Sponsors
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Purdue University
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Central South University
OTHER
Responsible Party
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Yanhui Liao
Dr.
References
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Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
Liao Y, Wu Q, Kelly BC, Zhang F, Tang YY, Wang Q, Ren H, Hao Y, Yang M, Cohen J, Tang J. Effectiveness of a text-messaging-based smoking cessation intervention ("Happy Quit") for smoking cessation in China: A randomized controlled trial. PLoS Med. 2018 Dec 18;15(12):e1002713. doi: 10.1371/journal.pmed.1002713. eCollection 2018 Dec.
Liao Y, Wu Q, Tang J, Zhang F, Wang X, Qi C, He H, Long J, Kelly BC, Cohen J. The efficacy of mobile phone-based text message interventions ('Happy Quit') for smoking cessation in China. BMC Public Health. 2016 Aug 19;16(1):833. doi: 10.1186/s12889-016-3528-5.
Study Documents
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Document Type: Study Protocol
Please send me email: [email protected] if you cannot open it.
View DocumentOther Identifiers
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2015S007
Identifier Type: -
Identifier Source: org_study_id
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