RCT for Evaluation of Online Social Networking Intervention in Smoking Cessations

A Randomized Controlled Trial Evaluating Efficacy of an Intervention Which Enhances Social Support and Positive Affect Through Online Social Networking in Smoking Cessations

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.

Study Overview

• Status: Unknown
• Conditions: Health Behavior; Self Efficacy
• Intervention / Treatment: Behavioral: Basic health education messages; Behavioral: WeChat interactive peer support group

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), vi) 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 Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 666888
    • Centre for Health Behaviours Research, the Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cigarettes consumed per day as compared to that of the baseline	Number of cigarettes consumed per day as compared to that of the baseline at 6 months post end-of-intervention	6 months
Positive and Negative Affect Scale score	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.	6 months
Smoking Self-Efficacy Questionnaire score	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.	6 months
Subjective Norms Scale score	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.	6 months
Attitude Towards Smoking Scale score	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.	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ANTICIPATED): January 31, 2018

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (ACTUAL): January 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; smoking cessation; social support; theory-based; positive effect; online social networking
• Other Study ID Numbers: HMRF 1213049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No