Happy Quit for Smoking Cessation in China

Smoking Cessation Clinical Trial

— HQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693626
• Other study ID #: 2015S007
• Status: Completed
• Phase: N/A
• Start date: August 17, 2016
• Est. completion date: November 27, 2017

Study information

• Verified date: April 2018
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1369
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Central South University	Johns Hopkins Bloomberg School of Public Health, Purdue University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be self-reported and biologically verified continuous smoking abstinence.		Six month
Secondary	A secondary outcome will be point prevalence of abstinence.		six month