NCT06570122

Brief Summary

This study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention tailored specifically for smoking parents.

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

Outcome Measures

Primary Outcomes (2)

  • Self-reported 7-day point prevalence quit rate

    Self-reported 7-day point prevalence quit rate in the two groups

    3 and 6 months follow-up

  • Eligibility rate

    the percentage of eligible smokers out of the total number of smokers screened

    baseline

Secondary Outcomes (2)

  • Consent rate

    baseline

  • Percentage of Participant Engagement with E-Messages and Counselor Chats

    3 months follow-up

Study Arms (2)

AI chatbot support group

EXPERIMENTAL

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

Behavioral: 5A's/5R's adviceOther: Health warning leafletBehavioral: AI-powered chatbot support

Control group

ACTIVE COMPARATOR

5A's/5R's advice + health warning leaflet

Behavioral: 5A's/5R's adviceOther: Health warning leaflet

Interventions

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 chatbot support groupControl group

The health warning leaflet provides essential information on the dangers of secondhand and thirdhand smoke. It outlines how exposure to these forms of smoke can harm both smokers and non-smokers, particularly children, by increasing the risk of respiratory illnesses and other health issues.

AI chatbot support groupControl group

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

AI chatbot support group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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
  • have a smartphone and a WeChat account, 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

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

Data Sharing

IPD Sharing
Will not share

Locations