Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID07014124

mHealth-based Motivational Counselling Integrated with Nicotine Replacement Therapy Sampling for Fathers of Sick Children Who Smoke: A Pilot Randomized Controlled Trial

Led by The University of Hong Kong · Updated on 2025-06-10

160

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a proactive intervention to help fathers of sick children quit smoking. This study focuses on fathers who smoke daily and live with their children, aiming to increase smoking abstinence through a combination of brief advice, nicotine replacement therapy (NRT) sampling, and mobile health (mHealth) counseling. The pilot randomized trial will assess the intervention's feasibility, acceptability, and preliminary effectiveness, with follow-ups at 1, 3, and 6 months after enrollment. Participants will be randomly assigned to one of two groups. The intervention group receives a 1-week free sample of NRT patches or gum to encourage quitting without pressure, along with motivational messages via WhatsApp over 3 months. The control group receives brief advice on protecting children from secondhand smoke and self-help materials without follow-up support. Additional counseling and referral to smoking cessation services are offered as needed. Throughout the study, researchers will collect survey data by phone and saliva samples from children for biochemical validation of smoking abstinence at 3 and 6 months. Participants in the intervention group will also be interviewed about their perceptions of the program. Primary outcomes include biochemically validated smoking abstinence at 3 months. Secondary outcomes cover abstinence at 6 months, self-reported quit attempts, smoking reduction, respiratory symptoms, and family well-being. Incentives are provided to encourage participation and completion of assessments.

CONDITIONS

Brief Title

Smoking Cessation for Fathers of Sick Children

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male parents aged 18 years or older who smoke at least one cigarette daily in the past 7 days
  • Living with a child under 18 years who attends the clinic or pediatric ward
  • Hong Kong residents able to read and communicate in Cantonese or Putonghua
  • Own a smartphone and can use instant messaging apps like WhatsApp or Facebook
  • Children under 18 years living with at least one parent who smokes daily in the past 7 days
  • Children able to provide saliva samples for research
Not Eligible

You will not qualify if you...

  • Parents with a history of psychiatric or psychological disease or currently using psychotropic medications
  • Parents currently using smoking cessation medications or services
  • Children with serious health conditions such as chronic or genetic diseases
  • Children participating in other clinical trials that may affect this study's results
  • Children living in highly contaminated or disease-prone environments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 3 months

Participants in the intervention group receive a 1-week free sample of nicotine replacement therapy (NRT) patch or gum and motivational messages via WhatsApp over 3 months. Participants in the control group receive brief advice and self-help materials without follow-up interventions.

Regular telephone surveys and face-to-face saliva sample collections at 3 months

Follow-up

Duration - Up to 6 months post-enrollment

Participants are followed up at 1, 3, and 6 months after enrollment to assess smoking abstinence and other outcomes, including biochemical validation using children's saliva samples and qualitative interviews for the intervention group.

Telephone surveys at 1, 3, and 6 months; face-to-face saliva collections at 3 and 6 months; qualitative interviews at 6 months for intervention group

Trial Site Locations

Total: 1 location

1

School of Nursing, The University of Hong Kong

Hong Kong, Pokfulam, Hong Kong, 999077

Actively Recruiting

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Research Team

S

Shengzhi Zhao, PhD

M

Mengyao Li, MPhil

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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