NCT06570070

Brief Summary

This study aims to explore the feasibility and preliminary effectiveness of AI-powered chatbot support in community smokers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

August 16, 2024

Last Update Submit

August 22, 2024

Conditions

Smoking CessationMobile Health

Outcome Measures

Primary Outcomes (1)

  • Biochemical validated quit rate at 6 months follow-up

    The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide \< 4 ppm or salivary cotinine \< 30 ng/ml)

    6 months follow-up

Secondary Outcomes (6)

  • Biochemical validated quit rate at 3 months follow-up

    3 months follow-up

  • Self-reported 7-day point prevalence quit rate

    3 and 6 months follow-up

  • Smoking reduction rate

    3 and 6 months follow-up

  • Eligibility rate

    baseline

  • Consent rate

    baseline

  • +1 more secondary outcomes

Study Arms (3)

AI support group

EXPERIMENTAL

AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet

Behavioral: 5A's/5R's adviceOther: Brief leaflet on health warning and smoking cessationOther: Self-help smoking cessation bookletBehavioral: AI-powered chatbot support

Counselor support group

EXPERIMENTAL

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

Behavioral: 5A's/5R's adviceOther: Brief leaflet on health warning and smoking cessationOther: Self-help smoking cessation bookletBehavioral: Counselor individual support

Control group

ACTIVE COMPARATOR

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

Behavioral: 5A's/5R's adviceOther: Brief leaflet on health warning and smoking cessationOther: Self-help smoking cessation booklet

Interventions

5A's/5R's adviceBEHAVIORAL

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.

AI support groupControl groupCounselor support group
Brief leaflet on health warning and smoking cessationOTHER

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.

AI support groupControl groupCounselor support group
Self-help smoking cessation bookletOTHER

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

AI support groupControl groupCounselor support group
AI-powered chatbot supportBEHAVIORAL

Participants will receive three months of AI-powered chatbot, equipped with personalized interactions and real-time support, via WeChat.

AI support group
Counselor individual supportBEHAVIORAL

Participants will receive three months of counselor-led individual 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.

Counselor support group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Normal University

Zhuhai, Guangdong, 519087, China

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Xue Weng

CONTACT

3621259xueweng@bnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 26, 2024

Study Start

September 1, 2024

Primary Completion

June 20, 2025

Study Completion

December 30, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations

CN(1)