Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Smoking Cessation
  • Tobacco Use Cessation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Objectives: Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S). Design and subjects: Pragmatic, in...

Objectives: Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S). Design and subjects: Pragmatic, individual randomized controlled trial in 664 daily smokers proactively recruited in smoking hotspots in Hong Kong. Interventions: Subjects in the Intervention group will receive face-to-face brief advice (including SC services referral) using AWARD model and 1-week free NRT sample (NRT-S) at baseline; and 12-week personalized behavioral support using interactive communication technologies (include regular tailored messages on abstinence, and synchronous IM Apps [e.g. WhatsApp] conversation with trained SC advisors and a Chatbot). Subjects in the Control group will receive the same AWARD advice without NRT-S at baseline, and regular short-message-service messages on general health and reminders to participate in follow-up. Main outcome measures: Primary outcomes are carbon monoxide validated smoking abstinence at 6-month and 12-month. Secondary outcomes include self-reported past 7-day abstinence, smoking reduction, quit attempt, SC services use, NRT use, self-efficacy on quitting and quality of life. Data analysis: Intention-to-treat and cost-effectiveness analyses will be conducted. Mediation analyses will explore the underlying mechanisms of Chatbot and IM Apps behavioral support to promote quitting. Individual interviews with quitters and non-quitters, and content analysis of Chatbot/IM Apps will be conducted to have in-depth understanding on the effects of intervention on various outcomes. Expected results: The Intervention group will have statistically significant higher validated smoking abstinence rates than the Control group at 6-month and 12-month.

Tracking Information

NCT #
NCT04001972
Collaborators
Food and Health Bureau, Hong Kong
Investigators
Principal Investigator: Man Ping Wang, PhD The University of Hong Kong