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Happy Quit for Smoking Cessation in China (HQ)

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ClinicalTrials.gov Identifier: NCT02693626
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Purdue University
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
Yanhui Liao, Central South University

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: intensive cessation message Behavioral: Not intensive cessation message Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Efficacy of Mobile Phone-based Text Message Interventions ('Happy Quit') for Smoking Cessation in China
Actual Study Start Date : August 17, 2016
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The primary outcome will be self-reported continuous smoking abstinence. [ Time Frame: three month ]

Secondary Outcome Measures :
  1. A secondary outcome will be point prevalence of abstinence. [ Time Frame: six month ]

Other Outcome Measures:
  1. A third outcome will be reductions in number of cigarettes smoked per day. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 15OCCSULiaoYanhui
Please send me email: tangliaoyanhui@163.com if you cannot open it.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanhui Liao, Dr., Central South University
ClinicalTrials.gov Identifier: NCT02693626     History of Changes
Other Study ID Numbers: 2015S007
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: I would be happy to share the data with everyone.

Keywords provided by Yanhui Liao, Central South University:
mobile phone-based text message interventions
'Happy Quit'
smoking cessation