Helping Smokers to Quit Via the Smoke-free Teen Contest 2011: A Randomized Controlled Trial

NCT01671553 | Unknown DMC

• 1 other identifier: COSH-SmokefreeTeen
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

Background The home is the primary source of SHS exposure. The scientific evidence shows that there is no risk-free level of exposure to SHS that stop smoking is the sole way to completely eliminate the risk of SHS exposure. Although research studies indicated that smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS exposure, governments lack the authority to restrict smoking in homes. Therefore, parental cessation is a more effective means to reduce the SHS exposure. Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect of different smoking cessation approaches through the Smoke-free Teen Contest. The specific objectives of the study are to test the effectiveness of different smoking cessation approaches on quit rate and change in smoking behaviours among smokers who are referred by Hong Kong Council on Smoking and Health (COSH). Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1) the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and (ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6 months. Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH), were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized by COSH. Those smokers will be randomized into two groups (Intervention group and Control group) using the clustered randomization method by school. After the clustered randomization, the oral consent of eligible subjects were obtained to the study through telephone interview. Intervention group will receive 1,2,3, 8-week and 6-month telephone follow-up after baseline, while control group will only receive 6-month telephone follow-up after baseline. Those participants who reported to have stopped smoking will be invited for biochemical validation of smoking status at 6-month follow-up. Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will lead to significant increases in rates of smoking cessation in the intervention groups than the control group.

Conditions

Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (1)

• The self-reported 7-day point prevalence (pp) quit rate at 6 months

  Whether the participant has quitted smoking in the past seven days at the time point of 6 months

  Six months

Secondary Outcomes (1)

• Biochemical validated quit rate at 6 months

  Six months

Study Arms (2)

Counseling group

EXPERIMENTAL

Study participants in the intervention group were received an intensive smoking cessation telephone counselling with 2-weeks free and 6-weeks discount nicotine replacement therapy (NRT).

Behavioral: Counseling group

Control group

NO INTERVENTION

Study participants in the control group were not received any quitting assistance other than the self-help materials provided by Hong Kong Council on Smoking and Health (COSH).

Interventions

Counseling group BEHAVIORAL

The content for the brief counseling group adopts a AWARD approach including asking the smoking habit, warning about the health risks associated with smoking, advising the smokers to quit, referring to specialized service, and repeating the above message. Additional telephone follow-up counseling at 1, 2, 3 and 8-week will be made to the participants in this group.

Counseling group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hong Kong residents aged 18 or above
• Able to communicate in Cantonese
• Intend to quit smoking

You may not qualify if:

• Smokers who are psychologically or physically unable to communicate
• Currently following other forms of smoking cessation programme
• Have a previous history of allergy to NRT patch or gum

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong SAR, China

RECRUITING

Study Officials

• Sophia SC Chan, PhD

  HKU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia SC Chan, PhD

CONTACT

852-28192622; nssophia@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

CN (1)