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

November 2, 2020 updated by: Dr. LI William Ho Cheung, The University of Hong Kong

Effectiveness of Using Adventure-based Training and WhatsApp Group to Relieve Emotion and Pressure so as to Quit Smoking: A Pilot Randomized Control Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Adventure-based intervention group
One-day adventure-based training will be assigned to subjects and the activities include wall climbing, rope course and health talk on mood, pressure management and smoking cessation.
Experimental: 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.
Behavioral: WhatsApp intervention group
A WhatsApp group will be opened for the subjects and we will send messages about mood and pressure management to them and encourage them to quit smoking. The subjects can share their unhappy things in the group.
Other: 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.
Behavioral: Control group
Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12-, 24-month and smoking cessation counselling will be delivered to the subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported 7-day point prevalence
Time Frame: 6-month
The subjects will be asked whether they have smoked cigarette in the past 7 day at 6-month
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical validated quit rate
Time Frame: 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.
6-month
Change in Depressive symptoms
Time Frame: 6-month
A 20-item scale (CESDC) will be used to assess the depressive symptoms of the subjects after 6 months.
6-month
Change in Self-esteem
Time Frame: 6-month
A 10-item scale (RSES) will be used to assess the self-esteem level of the subjects after 6 months.
6-month
Change in Quality of life
Time Frame: 6-month
A 11-item scale (SF-6D) will be used to assess the quality of life of the subjects after 6 months.
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YouthQuitline_RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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