RCT for Evaluation of Online Social Networking Intervention in Smoking Cessations

NCT ID: NCT03387800

Last Updated: 2018-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Self Efficacy Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Basic health education messages

Intervention Type BEHAVIORAL

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.

WeChat interactive peer support group

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Basic health education messages

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Zixin Wang

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zixin Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HMRF 1213049

Identifier Type: -

Identifier Source: org_study_id

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