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Trial record 10 of 37 for:    smoking [CONDITION] AND child [AGE-GROUP] | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03021655
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. LI William Ho Cheung, 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Adventure-based intervention group Behavioral: WhatsApp intervention group Behavioral: Control group Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Using Adventure-based Training and WhatsApp Group to Relieve Emotion and Pressure so as to Quit Smoking: A Pilot Randomized Control Trial
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021655


Contacts
Contact: Ho-cheung Li, PhD 39176634 william3@hku.hk

Locations
China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: William Li, PhD    852-39176634    william3@hku.hk   
Principal Investigator: Ho Cheung William Li, PhD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ho-cheung Li, PhD The University of Hong Kong

Responsible Party: Dr. LI William Ho Cheung, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03021655     History of Changes
Other Study ID Numbers: YouthQuitline_RCT
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. LI William Ho Cheung, The University of Hong Kong:
Youth
Randomized controlled trial
Adventure-based training
WhatsApp