NCT02007369

Brief Summary

According to the Census \& Statistics Department, there are still 659,300 daily smokers (11.1%) in Hong Kong. Smoking is addictive, and it is difficult for some motivated smokers to quit without assistance. About 33.2% daily smokers in Hong Kong had tried quitting but they could not maintain abstinence. Relapse prevention is aimed at providing interventions to prevent relapse after starting the abstinence status. This pilot single-blind randomized controlled trial (proof of concept study) will test the effectiveness of social networking services for relapse prevention. The study will first recruit 6 quitters and 6 relapsers for a qualitative interview for the design of intervention. Then, the pilot-RCT trial will recruit 120 participants who have recently quitted smoking, and they will be randomly allocated to 2 intervention groups and one control group. The 2 intervention groups will be arranged to join a WhatsApp or Facebook group for receiving quitting advices from the group moderators and sharing quitting experience with other participants. All participants will receive a self-help booklet of relapse prevention, and will be followed up at 6 weeks, 3 months and 6 months. The primary outcome is the self-report relapse rate (Relapse is tentatively defined as smoking 5 cigarettes in 3 consecutive days since joining the RCT among the 3 study arms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 11, 2016

Completed
Last Updated

January 4, 2017

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

November 28, 2013

Results QC Date

July 9, 2015

Last Update Submit

November 16, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self Reported Relapse Rate at 2 Months

    Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 2 months.

    2 months after joining the groups for the social networking services.

  • Self Reported Relapse Rate at 6 Months

    Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 6 months.

    6-months

Secondary Outcomes (2)

  • Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 2 Months

    2 months

  • Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 6 Months

    6 months

Study Arms (3)

WhatsApp

EXPERIMENTAL

Provide peer support and deliver relapse prevention messages through WhatsApp for 8 weeks and telephone follow ups

Behavioral: WhatsApp

Facebook

EXPERIMENTAL

Provide peer support and deliver relapse prevention messages through Facebook for 8 weeks and telephone follow ups

Behavioral: Facebook

Control

NO INTERVENTION

Telephone follow ups and received a self-help book only

Interventions

WhatsAppBEHAVIORAL

Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp and the duration of the intervention will be 8 weeks.

WhatsApp
FacebookBEHAVIORAL

Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook and the duration of the intervention will be 8 weeks.

Facebook

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoked at least 1 cigarette a day when first joined ICSC
  • Aged 18 or above at the baseline of the RCT
  • Clients who have received 3 to 5 smoking cessation counseling provided by ICSC
  • Reported tobacco abstinence in the past 7 days at the 8-week follow-up since receiving treatment from ICSC
  • Able to communicate in Cantonese and read Chinese
  • Have a local network mobile phone with mobile internet access

You may not qualify if:

  • Those with unstable physical or psychological conditions as advised by the doctor or counselor in charge
  • Smokers with diagnosed alcohol dependence by clinicians or the score of the Alcohol Use Disorders Identification Test (AUDIT) is 8 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Centres on Smoking Cessation (ICSC), Tung Wah Groups of Hospital (TWGH)

Hong Kong, China

Location

Related Publications (1)

  • Cheung YT, Chan CH, Lai CK, Chan WF, Wang MP, Li HC, Chan SS, Lam TH. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Oct 22;17(10):e238. doi: 10.2196/jmir.4829.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Most subjects had already quit for a few weeks before joining the RCT, so the present RCT did not examine if the intervention helped subjects manage smoking urges at the early stage of quitting. Also, the pilot RCT had small sample size.

Results Point of Contact

Title
Dr. Cheung, Yee Tak Derek
Organization
School of Public Health, The University of Hong Kong

Study Officials

  • Tai Hing Lam, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 10, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

January 4, 2017

Results First Posted

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations