RCT for Evaluation of Online Social Networking Intervention in Smoking Cessations

Health Behavior Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03387800
• Other study ID #: HMRF 1213049
• Status: Active, not recruiting
• Phase: N/A
• First received: December 18, 2017
• Last updated: December 22, 2017
• Start date: August 1, 2015
• Est. completion date: January 31, 2018

Study information

• Verified date: December 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: January 31, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Health Behavior
• Self Efficacy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Centre for Health Behaviours Research, the Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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