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NCT Number: NCT07014124

Smoking Cessation for Fathers of Sick Children

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The University of Hong Kong

Hong Kong, Pokfulam, 999077

Location status: Recruiting

Location contact

Ka Ka Siu, PhD

SUB_INVESTIGATOR

Man Ping Wang, PhD

SUB_INVESTIGATOR

Mengyao Lee, MPhil

CONTACT

[email protected]

+852 6851 8462

Shengzhi Zhao, PhD

CONTACT

[email protected]

+852 6561 4500

Shengzhi Zhao, PhD

PRINCIPAL_INVESTIGATOR

Sophia Chan, PhD

SUB_INVESTIGATOR

Tzu Tsun Luk, PhD

SUB_INVESTIGATOR

About this study

Targeted participants are fathers of sick children who smoke daily in the past 7 days and live together with their children. The primary caregiver will be selected if both parents smoke. Participants will be recruited from pediatric wards/outpatient departments of Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. The recruitment will be extended to other public hospitals if needed.

This study will be a two-arm, parallel pilot randomized trial with follow-ups at 1-, 3-, and 6-month since enrolment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. Surveys will be collected via telephone and children's saliva will be collected face-to-face at 3-months and 6-months after randomisation using Alere iScreen OFD saliva cotinine test device. Semi-structured individual telephone or face-to-face in-depth interviews will be conducted with the participants in the intervention group at 6 months follow-up to explore the participants' perception towards the intervention.

This study's clinical outcome will be biochemically validated abstinence at 3 months after randomisation. Secondary outcomes include validated abstinence at 6 months after randomisation, self-reported 7-day point prevalence abstinence (PPA), 24-hour quit attempts, and smoking reduction by at least 50% at 3 and 6 months. Incentives of HK$200 will be given to participants who report 7-day PPA at 1 month post randomisation. Additionally, incentives of HK$ 500 will be provided for the completion of each biochemical validation (a total $1000 for validation at 3- and 6-month). Such an amount can increase the response rate in our experience. Another incentive of $200 will be given to subjects completing qualitative interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for parents:

  • 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
  • Owned a smartphone and can use an instant messaging app (e.g., WhatsApp, Facebook) Inclusion criteria for children
  • 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

Exclusion criteria

for parents

  • Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
  • Smokers using smoking cessation medications or other smoking cessation services or projects Exclusion criteria for children
  • 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

Treatment and study plan

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).

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).

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.

Primary outcomes

  1. Biochemically validated abstinence

    Time frame: 3-months follow-ups

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

Secondary outcomes

  1. Biochemically validated abstinence

    Time frame: 6-month follow-up

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

  2. Past 7-day point prevalence abstinence (PPA)

    Time frame: 3-month follow-up

    Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?

  3. Past 7-day point prevalence abstinence (PPA)

    Time frame: 6-month follow-up

    Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?

  4. Smoking reduction

    Time frame: 3-month follow-up

    50% or above reduction in cigarette consumption compared with baseline

  5. Smoking reduction

    Time frame: 6-month follow-up

    50% or above reduction in cigarette consumption compared with baseline

  6. Use of smoking cessation services

    Time frame: 3-month follow-up

    Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days?

  7. Use of smoking cessation services

    Time frame: 6-month follow-up

    Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days?

  8. Respiratory symptoms

    Time frame: 3-month follow-up

    Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list.

  9. Respiratory symptoms

    Time frame: 6-month follow-up

    Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list.

  10. Perceived family well-being

    Time frame: 3-month follow-up

    Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function.

  11. Perceived family well-being

    Time frame: 6-month follow-up

    Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function.

  12. Self-reported life quality

    Time frame: 3-month follow-up

    Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life.

  13. Self-reported life quality

    Time frame: 6-month follow-up

    Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life.

  14. Self-reported secondhand exposure

    Time frame: 3-month follow-up

    Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke.

  15. Self-reported secondhand exposure

    Time frame: 6-month follow-up

    Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke.

  16. Self-reported thirdhand exposure

    Time frame: 3-month follow-up

    Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke.

  17. Self-reported thirdhand exposure

    Time frame: 6-month follow-up

    Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke.

Study contacts

Contact information is provided by the study sponsor or research team.

Mengyao Li, MPhil

CONTACT

[email protected]

+852 6851 8462

Shengzhi Zhao, PhD

CONTACT

[email protected]

+852 6561 4500

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

mHealth-based Motivational Counselling Integrate With a Sample of Nicotine Replacement Therapy for Fathers of Sick Children Who Smoke Cigarettes: A Pilot Randomized Controlled Trial

Acronym: Quit-for-Love

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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