Clinical trial NCT03387800: RCT for Evaluation of Online Social Networking Intervention in Smoking Cessations
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Efficacy
Health Behavior
Keywords: randomized controlled trial
smoking cessation
social support
positive effect
online social networking
theory-based
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Self-reported 7-day point prevalence (pp) quit rate
timeFrame: 6 months
Secondary outcomes:
measure: Number of cigarettes consumed per day as compared to that of the baseline
timeFrame: 6 months
measure: Positive and Negative Affect Scale score
timeFrame: 6 months
measure: Smoking Self-Efficacy Questionnaire score
timeFrame: 6 months
measure: Subjective Norms Scale score
timeFrame: 6 months
measure: Attitude Towards Smoking Scale score
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zixin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: