Smoking Cessation for Fathers of Sick Children

NCT07014124 | Recruiting DMC

• 1 other identifier: Sick Children
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children.

Conditions

Cigarette Smoking; mHealth Intervention

Keywords

tobacco exposure; sick children; quit smoking; Nicotine replacement therapy; mHealth support; smoking fathers

Outcome Measures

Primary Outcomes (1)

• Biochemically validated abstinence

  Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device

  3-months follow-ups

Secondary Outcomes (17)

• Biochemically validated abstinence

  6-month follow-up

• Past 7-day point prevalence abstinence (PPA)

  3-month follow-up

• Past 7-day point prevalence abstinence (PPA)

  6-month follow-up

• Smoking reduction

  3-month follow-up

• Smoking reduction

  6-month follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

A 1-week free sample of NRT patch or gum will be provided to encourage quit attempt without the pressure of quitting successfully. mHealth messages will be provided to motivate and support quitting and improve the protection measured of SHS exposure for children throughout the intervention period of 3 months.

Behavioral: Nicotine Replacement Therapy (NRT) Sampling; Behavioral: mHealth-based motivational counselling; Behavioral: Brief cessation advice and self-help material

Control group

ACTIVE COMPARATOR

Participants in the control group will only receive brief advice on SHS protective measures. Self-help materials will also be provided without follow-up interventions.

Behavioral: Brief cessation advice and self-help material

Interventions

Nicotine Replacement Therapy (NRT) Sampling BEHAVIORAL

Participants will be advised to choose the NRT according to their preferences and daily cigarette consumption. Cigarette consumption of ≤20 daily will receive the 14mg patch or 2mg gum and participants consume \>20 cigarettes daily will receive the 21mg patch. An NRT use card (Appendix 6 draft) containing the instructions and potential side effects were given with a brief oral explanation. Full course of pharmacological treatment for 12-week are available in smoking cessation services. Participants requesting for additional or full course of NRT will be actively refer to the respective services as part of the Referral step in the AWARD model (Ask, Warn, Advise, Refer, and Do-it-again).

Intervention group

mHealth-based motivational counselling BEHAVIORAL

The mHealth intervention will be delivered via the most popular instant messaging app in Hong Kong (WhatsApp). A total of 24 messages with contents including the harms of smoking and smoke exposure for children, encouragement, benefits of quitting for children, methods of quitting, dealing with craving, and measures to reduce cigarette smoke exposure at home will be provided. The messages will be scheduled in a tapering schedule that participants will receive 5 messages in the first week, then cut down to 3 messages/week for the next 4 weeks and 1 message/week for the last 7 weeks. Using a more personalized approach, the messages will be tailored to the participants' motivation, intention to quit and other quitting patterns collected at baseline. Real-time conversations could be initiated by participants themselves, triggered by regular messages, or through prompt inquires (e.g., asking about the quitting progress).

Intervention group

Brief cessation advice and self-help material BEHAVIORAL

At baseline, participants will receive brief face-to-face advice on quitting smoking for the health of the children using the validated AWARD model (Ask, Warn, Advise, Refer, Do-it-again) with a print-based self-help material providing detailed information on health hazards of SHS exposure on children, methods to deal with craving and withdrawal symptoms, and measures on preventing SHS exposure for children at home.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents (mainly fathers) aged ≥18 years and smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
• Living with a child aged \<18 years who attended the clinic or were admitted to the pediatric ward
• Hong Kong residents able to read and communicate in Cantonese or Putonghua
• Children aged \<18 years who attended the clinic or were admitted to the pediatric ward
• Lives with at least one or more parents who smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
• Able to provide biochemical samples (e.g. saliva) for purpose of research

You may not qualify if:

• Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
• Children who already have serious health diseases (e.g.chronic disease, genetic disease)
• Children who are participating in other clinical trials that may affect the results of this study
• Children who live in certain environments, such as those living in highly contaminated areas or areas with other potential disease-causing factors

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Pokfulam, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Shengzhi Zhao, PhD

CONTACT

+852 6561 4500; lubabezz@connect.hku.hk

Mengyao Li, MPhil

CONTACT

+852 6851 8462; lmy0814@connect.hku.hk

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: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: June 10, 2025
• Study Start: March 18, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)