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Completed

NCT Number: NCT02693626

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intensive cessation message

Behavioral

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

Behavioral

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.

Primary outcomes

  1. The primary outcome will be self-reported and biologically verified continuous smoking abstinence.

    Time frame: Six month

Secondary outcomes

  1. A secondary outcome will be point prevalence of abstinence.

    Time frame: six month

Sponsors and collaborators

Lead sponsor

Central South University

Other

Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • Purdue University

Registry information

Official study title

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

Acronym: HQ

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 29, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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