Happy Quit for Smoking Cessation in China

Study Overview
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Brief Summary
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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.

Detailed Description
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Background: Considering the extreme shortage of smoking cessation services in China, and the acceptability, feasibility and efficacy of mobile phone-based text message interventions for quitting smoking in other countries, here a study of the efficacy of mobile phone-based text message interventions ('Happy Quit') for smoking cessation in Chinahas been proposed. 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.

Official Title
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The Efficacy of Mobile Phone-based Text Message Interventions ('Happy Quit') for Smoking Cessation in China

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: intensive cessation message
* Behavioral: Not intensive cessation message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily Chinese cigarette smokers. 18 years of age and older living. Being able to read and write in Chinese. Owning a text-capable cell phone and knowing how to text. Willing to make an attempt to quit smoking in the next month. Willing to provide informed consent to participate in the study. Exclusion Criteria: Nonsmokers Below 18 years old. Unable to read and write in Chinese.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive cessation message<br>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. | Behavioral: intensive cessation message<br>* 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.<br>|
| No Intervention: No cessation message intervention<br>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. | |
| Experimental: Not intensive cessation message<br>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. | Behavioral: Not intensive cessation message<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be self-reported and biologically verified continuous smoking abstinence. |  | Six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary outcome will be point prevalence of abstinence. |  | six month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile phone-based text message interventions, 'Happy Quit', smoking cessation