A Pilot Randomized Control Trial to Help Youth Smokers to Quit Smoking:
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03021655|
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Adventure-based intervention group Behavioral: WhatsApp intervention group Behavioral: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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.
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.
- 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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Ho-cheung Li, PhDfirstname.lastname@example.org|
|The University of Hong Kong||Recruiting|
|Hong Kong, China|
|Contact: William Li, PhD 852-39176634 email@example.com|
|Principal Investigator: Ho Cheung William Li, PhD|
|Principal Investigator:||Ho-cheung Li, PhD||The University of Hong Kong|