Smoking Cessation Clinical Trial
Official title:
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.
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.
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