NCT02693626

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,369

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

February 6, 2019

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

February 19, 2016

Last Update Submit

February 4, 2019

Conditions

Smoking Cessation

Keywords

mobile phone-based text message interventions'Happy Quit'smoking cessation

Outcome Measures

Primary Outcomes (1)

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

    Six month

Secondary Outcomes (1)

  • A secondary outcome will be point prevalence of abstinence.

    six month

Study Arms (3)

intensive cessation message

EXPERIMENTAL

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

No cessation message intervention

NO 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.

Not intensive cessation message

EXPERIMENTAL

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

Interventions

intensive cessation messageBEHAVIORAL

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.

intensive cessation message
Not intensive cessation messageBEHAVIORAL

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.

Not intensive cessation message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Daily Chinese cigarette smokers.
  • 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.

You may not qualify if:

  • Nonsmokers
  • Below 18 years old.
  • Unable to read and write in Chinese.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • 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.

    PMID: 30562352DERIVED

  • 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.

    PMID: 27543164DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 19, 2016

First Posted

February 29, 2016

Study Start

August 17, 2016

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

February 6, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

I would be happy to share the data with everyone.

Available IPD Datasets

Study Protocol (15OCCSULiaoYanhui)Access