Happy Quit for Smoking Cessation in China (HQ)

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: intensive cessation message; Behavioral: Not intensive cessation message

Detailed Description

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 China"has 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.

• Study Type: Interventional
• Enrollment (Actual): 1369
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Daily Chinese cigarette smokers.
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:

1. Nonsmokers
2. Below 18 years old.
3. Unable to read and write in Chinese.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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 Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central South University
• Collaborators: Johns Hopkins Bloomberg School of Public Health; Purdue University

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): August 17, 2016
• Primary Completion (Actual): November 27, 2017
• Study Completion (Actual): November 27, 2017

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: smoking cessation; mobile phone-based text message interventions; 'Happy Quit'
• Other Study ID Numbers: 2015S007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: I would be happy to share the data with everyone.

Study Data/Documents

1. Study Protocol
   Information identifier: 15OCCSULiaoYanhui
   Information comments: Please send me email: tangliaoyanhui@163.com if you cannot open it.