Mobile Phone-based Smoking Cessation Program

Not Applicable

Completed

• Conditions: Substance Use Disorder (SUD)

• Registration Number: NCT06747182
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

In this online, randomized controlled trial (RCT), the participants will be randomized and allocated in 1:1 ratio to mobile phone-based intervention group or to the wait-list control group. Participants will receive a 12-week intervention with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 2000 smokers with willingness to make a quit attempt within a month from October 2022 to April 2023 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in November 2023. The trial results will be available by the end of 2023 .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-01
• Study Completion: 2023-11-01
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• In this RCT, approximately 2,000 smokers (a smoker is defined as an individual who smoked 100 cigarettes in their lifetime, and currently smoke ≥ 5 cigarettes per day) who are willing to make a quit attempt within one month with CVDs diagnosis or risk.

Exclusion Criteria

• patients unwilling to quit smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Continuous smoking abstinence	at week 26 after the quit date	biologically verified continuous smoking abstinence at week 26 after the quit date

Secondary Outcome Measures

Name	Time	Method
7-day point prevalence smoking abstinence	week 1, 2, 3, 4, 8, 12, 16, 20 and 26	seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26
self-reported continuous smoking abstinence	week 4, 8, 12, 16, 20 and 26 after the quit date	self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.; 🇨🇳 Hangzhou, Zhejiang, China