NCT06127589

Brief Summary

This project aims to test the effectiveness of an integrated intervention of brief cessation advice (AWARD), Nicotine Replacement Therapy, and Instant Messaging support compared with waitlist control participants among adult daily smokers who lived with their children and non-smoking partners.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Feb 2024Sep 2027

First Submitted

Initial submission to the registry

October 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

October 10, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

Smoking CessationSecond Hand Smoke ExposureChildren HealthMobile Health InterventionNicotine Replacement TherapyFamily-based Intervention

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated abstinence

    Defined as exhaled carbon monoxide level \<4ppm and saliva cotinine level ≤30ng/ml

    6-month after recruitment

Secondary Outcomes (13)

  • Self-reported 7-day point prevalence quit rate (for smokers)

    3- and 6-month after recruitment

  • Self-reported reduction rate (for smokers)

    3- and 6-month after recruitment

  • Self-reported intention to quit (for smokers)

    3- and 6-month after recruitment

  • Smoking cessation service use (for smokers)

    3- and 6-month after recruitment

  • Self-rated health (for smokers)

    3- and 6-month after recruitment

  • +8 more secondary outcomes

Study Arms (2)

Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

EXPERIMENTAL

Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.

Behavioral: Brief cessation advice (AWARD)Drug: Nicotine Replacement Therapy (NRT)Behavioral: Instant messaging Support (IM)Behavioral: Financial Incentive (FI)Behavioral: Self-help smoking cessation bookletBehavioral: Environmental assessment derived intervention

Brief cessation advice (AWARD) + Waitlist for same intervention

ACTIVE COMPARATOR

Participants in the control group will receive the same AWARD brief advice model, self-help booklet at baseline, and financial incentives for validated abstinence at 3- and 6-month follow-up. After the 6-month follow-up, participants who continued to smoke will receive the remaining intervention components: 1-week sampling of NRT and 3 months instant messaging chat-based personalized psychosocial and behavioural counselling for quitting. Participants who validated abstinence at the 12 months or actively engaged in mobile Health counselling will also receive the financial incentives of HK$ 500 and HK$ 200, respectively (waitlist control). Similar to the Intervention group, environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.

Behavioral: Brief cessation advice (AWARD)Behavioral: Self-help smoking cessation bookletBehavioral: Environmental assessment derived intervention

Interventions

Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refuse to set a quit date).

Also known as: Brief Advice (BA)
Brief cessation advice (AWARD) + Waitlist for same interventionBrief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

1-week sampling of Nicotine Replacement Therapy (NRT) will be provided to support quit attempt. Full pharmacological treatment (12-week) will be available if needed.

Also known as: NRT
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

Chat-based mHealth personalized psychosocial and behavioural counselling (smoking cessation and SHS exposure reduction messages will be derived from previously tested interventional studies) using baseline children health and biofeedback data to support quitting throughout the intervention period of 3 months.

Also known as: IM
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

A financial incentive (vouchers) of HK$ 500 will be provided for biochemically validated smoking abstinence at 3- and 6-month follow-up. Considering a possibly low engagement rate of the smokers in mHealth-based support (17% in our previous trial, non-engagement mostly due to busy work), additional HK$ 200 will be provided for participants who actively engaged in the mHealth counselling (defined by have discussed quitting process for \>2 times) at 3-month follow-up.

Also known as: FI
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

A well-designed self-help booklet will be provided to guide and provide detailed information on smoking cessation. The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.

Also known as: Self-help material
Brief cessation advice (AWARD) + Waitlist for same interventionBrief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

In a selected subgroup of 50 families with an additional signed consents, four home visits will be done to: 1. Setup an indoor air quality (IAQ) monitor to collect 24hr air quality data (2 weeks), 2. Collect the monitor for data retrieval, 3. Setup the monitor at 6 months follow-up (2 weeks), 4. Collect the monitor for data retrieval. Environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.

Brief cessation advice (AWARD) + Waitlist for same interventionBrief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives

Eligibility Criteria

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

You may qualify if:

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the preceding 3-month and verified by exhaled carbon monoxide level of 4ppm (parts per million) or above, assessed by a validated Carbon monoxide Smokerlyzer®
  • Living with at least one child of primary 6 or below (aged 12 or below)
  • Living with at least one non-smoking family member
  • Living in deprived households (monthly household income of less than the median of household monthly income in Hong Kong, HK$ 28,000, or living in subdivided flats or social housing)
  • Able to communicate in Chinese (including reading Chinese in IM)
  • Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication

You may not qualify if:

  • Those who have communication barriers (either physically or cognitively)
  • Those who are currently participating in other smoking cessation programmes or services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Crisis InterventionNicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDrug TherapyTherapeutics

Central Study Contacts

Sophia SC Chan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

November 13, 2023

Study Start

February 5, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations