Smoking Cessation for Fathers of Sick Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotine Replacement Therapy (NRT) Sampling
BehavioralParticipants 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
BehavioralThe 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
BehavioralAt 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 3 interventions
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Biochemically validated abstinence
Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
Time frame
3-months follow-upsSecondary outcomes
1
Biochemically validated abstinence
Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
Time frame
6-month follow-up2
Past 7-day point prevalence abstinence (PPA)
Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?
Time frame
3-month follow-up3
Past 7-day point prevalence abstinence (PPA)
Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?
Time frame
6-month follow-up4
Smoking reduction
50% or above reduction in cigarette consumption compared with baseline
Time frame
3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov