Promoting Smoking Cessation in Campus

Sponsor

Beijing Normal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05777005

Collaborator

(none)

200

Enrollment

Location

Arms

9.8

Anticipated Duration (Months)

20.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to explore the effectiveness of a combined intervention using brief cessation advice and personalized WeChat support compared with the group support via WeChat on current smokers who join the smoking cessation contest at Beijing Normal University, Zhuhai.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Mobile Health	Behavioral: 5A's/5R's advice Other: Brief leaflet on health warning and smoking cessation Other: Self-help smoking cessation booklet Behavioral: Chat-based support Behavioral: WeChat group support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Promoting Smoking Cessation in Campus Via Smoking Cessation Contest: a WeChat-based Smoking Cessation Intervention

Actual Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 5A's/5R's advice+ Chat-based support+ WeChat group support+ health warning leaflet+ Self-help booklet	Behavioral: 5A's/5R's advice 5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit. Other: Brief leaflet on health warning and smoking cessation The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting. Other: Self-help smoking cessation booklet The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc. Behavioral: Chat-based support Participants will receive three months of chat-based support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting. Behavioral: WeChat group support Participants will receive three months of group support via WeChat.
Active Comparator: Control group 5A's/5R's advice+ WeChat group support+ health warning leaflet+ Self-help booklet	Behavioral: 5A's/5R's advice 5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit. Other: Brief leaflet on health warning and smoking cessation The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting. Other: Self-help smoking cessation booklet The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc. Behavioral: WeChat group support Participants will receive three months of group support via WeChat.

Arm

Intervention/Treatment

Experimental: Intervention group

5A's/5R's advice+ Chat-based support+ WeChat group support+ health warning leaflet+ Self-help booklet

Behavioral: 5A's/5R's advice

5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.

Other: Brief leaflet on health warning and smoking cessation

The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.

Other: Self-help smoking cessation booklet

The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.

Behavioral: Chat-based support

Participants will receive three months of chat-based support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.

Behavioral: WeChat group support

Participants will receive three months of group support via WeChat.

Active Comparator: Control group

5A's/5R's advice+ WeChat group support+ health warning leaflet+ Self-help booklet

Behavioral: 5A's/5R's advice

5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.

Other: Brief leaflet on health warning and smoking cessation

Other: Self-help smoking cessation booklet

The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.

Behavioral: WeChat group support

Participants will receive three months of group support via WeChat.

Outcome Measures

Primary Outcome Measures

Biochemical validated quit rate [6-month follow-up]
The primary outcomes are biochemically validated quit rate (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 6-month in the two groups

Secondary Outcome Measures

Biochemical validated quit rate [3-month follow-up]
The primary outcomes are biochemically validated quit rate (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 3-month in the two groups
Self-reported 7-day point prevalence quit rate [3 and 6 months follow-up]
Self-reported 7-day point prevalence quit rate in the two groups
Smoking reduction rate [3 and 6 months follow-up]
Rate of smoking reduction by at least half of baseline amount in the two groups
Engagement in chat-based/group support [3 and 6 months follow-up]
Self-reported engagement in chat-based/group support in the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aged 18 and above, reside in Zhuhai for the next 6 months;
smoke at least 1 cigarette or use e-cigarettes daily;
Having a smartphone and a WeChat account, being able to use WeChat skillfully.

Exclusion Criteria:

Smokers who have communication barrier (either physically or cognitively);
Smokers who are currently participating in other SC programmes or services

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Normal University	Zhuhai	Guangdong	China	519087

Sponsors and Collaborators

Beijing Normal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Normal University

ClinicalTrials.gov Identifier:

NCT05777005

Other Study ID Numbers:

Smoking Cessation in Campus

First Posted:

Mar 20, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 20, 2023