Mobile Phone-based Smoking Cessation Program

Mobile Phone-based Smoking Cessation Program for Individuals With Cardiovascular Risk or Disease in China

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 .

Study Overview

• Status: Completed
• Conditions: Substance Use Disorder (SUD)
• Intervention / Treatment: Other: mobile phone-based intervention

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310029
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: the wait-list control group
Experimental: mobile phone-based intervention group; Participants will receive a 12-week intervention with follow-up at week 26.	Other: mobile phone-based intervention; Participants in intervention group will receive a 12-week mobile phone-based intervention with follow-up at week 26.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous smoking abstinence	biologically verified continuous smoking abstinence at week 26 after the quit date	at week 26 after the quit date

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular diseases; smoke cessation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 0716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No