Mobile Phone-based Smoking Cessation Program

NCT06747182 | Completed DMC

• 1 other identifier: 0716
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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 .

Conditions

Substance Use Disorder (SUD)

Keywords

smoke cessation; cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• Continuous smoking abstinence

  biologically verified continuous smoking abstinence at week 26 after the quit date

  at week 26 after the quit date

Secondary Outcomes (2)

• 7-day point prevalence smoking abstinence

  week 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

Study Arms (2)

the wait-list control group

NO INTERVENTION

the wait-list control group

mobile phone-based intervention group

EXPERIMENTAL

Participants will receive a 12-week intervention with follow-up at week 26.

Other: mobile phone-based intervention

Interventions

mobile phone-based intervention OTHER

Participants in intervention group will receive a 12-week mobile phone-based intervention with follow-up at week 26.

mobile phone-based intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients unwilling to quit smoking

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310029, China

Location

MeSH Terms

Conditions

Substance-Related Disorders; Smoking Cessation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: October 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 13, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)