RCT for Evaluation of Online Social Networking Intervention in Smoking Cessations

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT03387800
Collaborator
(none)
408
1
2
30
13.6

Study Details

Study Description

Brief Summary

The proposed RCT evaluates the efficacy of the aforementioned novel 2-month online smoking cessation intervention in increasing 7-day point prevalence quit rate over a 6-month follow-up period among Chinese adult smokers in Hong Kong.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Basic health education messages
  • Behavioral: WeChat interactive peer support group
N/A

Detailed Description

Aims and hypothesis: The proposed RCT evaluates the efficacy of the aforementioned novel 2-month online smoking cessation intervention in increasing 7-day point prevalence quit rate over a 6-month follow-up period among Chinese adult smokers in Hong Kong. It is hypothesized that the quit rate of the intervention group would be higher than that of the control group at 6 month follow up (i.e. one-sided hypothesis).

Design and subjects: The RCT study will randomize participants into the intervention group or the control group. Prior to randomization, a baseline telephone survey will be conducted. Phone interviews will be conducted to evaluate the outcomes at Months 3 and 6 after completion of the intervention. Interviewers will be blinded from the randomization status. The inclusion criteria are: i) current smokers who have smoked at least one cigarette in the past seven days prior to the baseline survey, ii) age 18 years old or above, iii) able to communicate in Chinese (Cantonese), iv) having access to a smart phone or mobile electronic devices and social networking media (WeChat), v) willing to be followed up (Months 3 and 6),

  1. should own a smart phone or a similar device.

Study instruments: Structured questionnaires.

Interventions: The 2-month intervention includes i) interactive online support groups and ii) immediate preventive 'SOS' cue to action messages to be sent to fellow support group members in need via WeChat. Besides, basic health education messages will be sent to both the intervention and the control groups.

Main outcome measures: self-reported 7-day point prevalence (pp) quit rate of smokers at 6 months post end-of-intervention.

Data analysis and expected results: Baseline characteristics between the two groups will be compared using t-test and chi-square test as appropriate. To evaluate efficacy in terms of the primary outcome, absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT) at Months 3 and 6 and their 95% confidence intervals will be derived. Mixed effects models will be used to compare the differential changes on the outcome variables across the time points Months 0, 3 and 6 between the two study arms with adjustment for potential confounding variables. Significance differences in smoking cessation will be found among the two groups.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Randomized Controlled Trial Evaluating Efficacy of an Intervention Which Enhances Social Support and Positive Affect Through Online Social Networking in Smoking Cessations
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Jul 31, 2017
Anticipated Study Completion Date :
Jan 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: WeChat interactive peer support group

Participants will be grouped together by the researcher to form closed online peer support groups (with group names they choose). Activities on the WeChat groups serve two functions: i) It enhances social support among peer members toward smoking cessation. ii) The online support group also enhances the participants' positive affect.

Behavioral: Basic health education messages
Messages containing basic health education materials, including perceived severity of smoking, perceived benefit of smoking cessation and tips on resisting situational temptations will be sent to the participants of both arms through WeChat after randomization takes place.

Behavioral: WeChat interactive peer support group
Participants will be grouped together by the researcher to form closed online peer support groups (with group names they choose). Activities on the WeChat groups serve two functions: i) It enhances social support among peer members toward smoking cessation. ii) The online support group also enhances the participants' positive affect.

Active Comparator: Basic health education messages

Members of the control group will receive health education messages that will also be sent to the intervention group through WeChat. The messages include topics on physical and psychological aspects of perceived severity of smoking and perceived benefits of smoking cessation, and tips/skills on resisting situational temptations that may lead to relapse.

Behavioral: Basic health education messages
Messages containing basic health education materials, including perceived severity of smoking, perceived benefit of smoking cessation and tips on resisting situational temptations will be sent to the participants of both arms through WeChat after randomization takes place.

Outcome Measures

Primary Outcome Measures

  1. Self-reported 7-day point prevalence (pp) quit rate [6 months]

    Self-reported 7-day point prevalence (pp) quit rate of smokers at 6 months post end-of-intervention

Secondary Outcome Measures

  1. Number of cigarettes consumed per day as compared to that of the baseline [6 months]

    Number of cigarettes consumed per day as compared to that of the baseline at 6 months post end-of-intervention

  2. Positive and Negative Affect Scale score [6 months]

    Positive and Negative Affect Scale score as compared to that of the baseline at 6 months post end-of-intervention. Positive and Negative Affect Scale is consisted of two subscales, i.e. Positive Affect Scale (total score is ranged from 10 to 50, the higher value represents a better outcome) and Negative Affect Scale (total score is ranged from 10 to 50, the higher value represents a worse outcome). Two subscales will not be combined to compute a total score.

  3. Smoking Self-Efficacy Questionnaire score [6 months]

    Smoking Self-Efficacy Questionnaire score as compared to that of the baseline at 6 months post end-of-intervention. The total score is ranged from 12 to 60. The higher values represents a better outcome.

  4. Subjective Norms Scale score [6 months]

    Subjective Norms Scale score as compared to that of the baseline at 6 months post end-of-intervention. The total score is 6 to 30. The higher value represents a better outcome.

  5. Attitude Towards Smoking Scale score [6 months]

    Attitude Towards Smoking Scale score as compared to that of the baseline at 6 months post end-of-intervention. The total score is ranged from 8 to 56. The higher values represents a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Current smokers who have smoked at least one cigarette in the past seven days prior to the baseline survey

  • Age 18 years old or above

  • Able to communicate in Chinese (Cantonese)

  • Having access to a smart phone or mobile electronic devices and social networking media (WeChat), v) willing to be followed up (Months 3 and 6)

  • Should own a smart phone or a similar device

Exclusion Criteria:
  • Physically or mentally unfit

  • Having participated in smoking cessation programs (last six months)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Health Behaviours Research, the Chinese University of Hong Kong Hong Kong Hong Kong 666888

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Zixin Wang, PhD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zixin Wang, Research Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03387800
Other Study ID Numbers:
  • HMRF 1213049
First Posted:
Jan 2, 2018
Last Update Posted:
Jan 2, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zixin Wang, Research Assistant Professor, Chinese University of Hong Kong

Study Results

No Results Posted as of Jan 2, 2018