A Pilot Randomized Control Trial to Help Youth Smokers to Quit Smoking:

Not Applicable

• Conditions: Smoking Cessation
• Interventions: Behavioral: Control group; Behavioral: Adventure-based intervention group; Behavioral: WhatsApp intervention group

• Registration Number: NCT03021655
• Lead Sponsor: The University of Hong Kong

Brief Summary

This study is a 3-arm randomized controlled trial including: (1) Adventure-based training intervention group, (2) WhatsApp intervention group and (3) Control group.

Detailed Description

Depression and stress are obstacles of youth smokers to quit smoking, youth smokers who have positive thinking and less depression exhibited smoking abstinence at last. Adventure-based training could enhance participants' self-efficacy, self-esteem and also improve mental health of children and youth by doing physical activity. On the other hand, previous mobile phone-based studies (e.g. short messaging services or Apps) showed that the mental health of youth had been improved by providing instant response to the subjects when they felt depressed. A paper published recently proved that WhatsApp group could prevent relapse among the quitters. Thus, adventure-based training and social support in WhatsApp group would predict to reduce depression and stress so as to quit smoking in youth.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Primary Completion: 2021-11
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Hong Kong resident aged 25 or below
• Able to communicate, read and write in Cantonese/ Chinese
• Smoked in the past 30 days
• Mobile can access internet
• Would access internet through mobile or at home

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Exclusion Criteria

• Have difficulty to communicate via telephone
• Ever used/using psychiatric drugs
• Physically disabled
• Having queries irrelevant to tobacco control
• Undergoing other smoking cessation service

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	For the control group, the subjects will receive telephone counseling on quitting smoking at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.
Adventure-based intervention group	Adventure-based intervention group	Adventure-based intervention group included 1 day-camp and will be divided into 2 parts: (1) physical activity such as wall climbing, ropes course etc, (2) health education delivering about the relationship of self-efficacy, self-esteem, emotion and smoking abstinence. The training will be held before the 6-month follow-up. Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.
WhatsApp intervention group	WhatsApp intervention group	For WhatsApp intervention group, not more than 8 subjects with same gender will be assigned into a group. Messages about mood and stress management will be sent to the group per week and the group will last for 6 months. It aims to relieve their pressure and emotion by sharing their unhappy things with other subjects. Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.

Primary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence	6-month	The subjects will be asked whether they have smoked cigarette in the past 7 day at 6-month

Secondary Outcome Measures

Name	Time	Method
Biochemical validated quit rate	6-month	Bio-chemical validated quit rate will be conducted if the subjects who reported they have been stop smoking for at least 7 days at 6-month. They will be invited to perform saliva cotinine test (using NicAlert strip) plus exhaled carbon monoxide text to validate the smoking status.
Change in Self-esteem	6-month	A 10-item scale (RSES) will be used to assess the self-esteem level of the subjects after 6 months.
Change in Depressive symptoms	6-month	A 20-item scale (CESDC) will be used to assess the depressive symptoms of the subjects after 6 months.
Change in Quality of life	6-month	A 11-item scale (SF-6D) will be used to assess the quality of life of the subjects after 6 months.

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, China