Clinical trial NCT02693626: Happy Quit for Smoking Cessation in China
Official title: The Efficacy of Mobile Phone-based Text Message Interventions ('Happy Quit') for Smoking Cessation in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: mobile phone-based text message interventions
'Happy Quit'
smoking cessation
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2016-02-29
Enrollment: 1369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome will be self-reported and biologically verified continuous smoking abstinence.
timeFrame: Six month
Secondary outcomes:
measure: A secondary outcome will be point prevalence of abstinence.
timeFrame: six month
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.