Mobile Phone-based Smoking Cessation Program

NCT ID: NCT06747182

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-11-01

Brief Summary

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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

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Conditions

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Substance Use Disorder (SUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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the wait-list control group

the wait-list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

mobile phone-based intervention group

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

Group Type EXPERIMENTAL

mobile phone-based intervention

Intervention Type OTHER

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

Interventions

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mobile phone-based intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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0716

Identifier Type: -

Identifier Source: org_study_id

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