NCT03169686

Brief Summary

This proposed project is to assess whether WeChat-based smoking cessation interventions ('WeChat WeQuit' program) will be effective at helping people in China who smoke, to quit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2.8 years until next milestone

Study Start

First participant enrolled

March 19, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

May 25, 2017

Last Update Submit

November 30, 2022

Conditions

Cigarette SmokingSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Biochemically Validated Continuously Abstinence

    The primary outcome will be biochemical validation of self-reported 26-week continuous smoking abstinence

    26 weeks

Secondary Outcomes (2)

  • Self-reported 7-day Point Abstinence

    26 weeks

  • Self-reported Continuous Abstinence

    26 weeks

Other Outcomes (1)

  • Smoking Reduction and Participation

    26 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive the 'WeChat WeQuit' program from the WeChat subscription account. The period for intervention was 14 weeks, including 2-week quiting preparation intervention and 12-week postquit intervention. The number of messages/pictures/audios received by participants will gradually decrease (will be intensively sent to them during 2-week prequit and 4-week postquit, and less intensively during 5-week to 12-week postquit), and follow-up questionnaires were sent only once a month in 14-28 weeks (week 16, 20, and 26 after the quit date). A WeChat group was created for answering questions from participants, and sharing the latest resources related to quitting smoking, and promoting communication between participants.

Behavioral: Cognitive and Behavioral Intervention

Control Group

NO INTERVENTION

Control group participants will not receive any smoking cessation messages by professional team. They will receive messages of thanking them for being in the study and reminding them of the time until their free month at the end of 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 week if they are still smoking will be checked at week 1, 4, 8, 12, 16, 20 and 26 points.

Interventions

Cognitive and Behavioral InterventionBEHAVIORAL

Participants who allocate to the intervention group will receive regular smoking cessation related information by professional team.

Intervention Group

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 smartphone and knowing how to use WeChat.
  • 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.
  • Smokers without attempt to quit.
  • Below 18 years old.
  • Unable to use smartphone and WeChat.
  • Unable to read and write in Chinese.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yanhui Liao

Hanzhou, Zhejiang, 360000, China

Location

Related Publications (1)

  • Tang J, Yang J, Liu Y, Liu X, Li L, Sun Y, Jin J, Fang Y, Zhou Z, Wang Y, Liu Y, Chen W, McNeill A, Kelly BC, Cohen JE, Liao Y. Efficacy of WeChat-based online smoking cessation intervention ('WeChat WeQuit') in China: a randomised controlled trial. EClinicalMedicine. 2023 May 18;60:102009. doi: 10.1016/j.eclinm.2023.102009. eCollection 2023 Jun.

    PMID: 37251625DERIVED

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

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
Attending Psychiatrist

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

March 19, 2020

Primary Completion

November 16, 2022

Study Completion

November 16, 2022

Last Updated

December 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

All individual participant data (without personal information) will be included in submission and will be available to other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

CN(1)