Self EfficacyNCT03387800
RCT for Evaluation of Online Social Networking Intervention in Smoking Cessations
A study testing Basic health education messages and WeChat interactive peer support group in people with Self Efficacy and Health Behavior, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy, Health Behavior
- What is being tested?
- Basic health education messages and WeChat interactive peer support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2015to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Physically or mentally unfit
- Having participated in smoking cessation programs (last six months)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888
About this study
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
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.
Read the 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.
- Conditions
- Self Efficacy, Health Behavior
- Being tested
- Basic health education messages, WeChat interactive peer support group
- Keywords
- randomized controlled trial, smoking cessation, social support, positive effect, online social networking, theory-based
- Medical subject headings
- Health Behavior, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic health education messagesBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WeChat interactive peer support group | Experimental | 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. Receives: Behavioral: Basic health education messages; Behavioral: WeChat interactive peer support group |
| Basic health education messages | Active comparator | 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. Receives: Behavioral: Basic health education messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Aug 2015
- Primary completion31 Jul 2017
- Study completion31 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zixin Wang, Chinese University of Hong Kong
- Investigators
- Zixin Wang, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387800
- Sponsor's protocol ID
- HMRF 1213049
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03387800
- Acronym / sponsor ID
- HMRF 1213049
- Conditions
- Self Efficacy, Health Behavior
- Keywords
- randomized controlled trial, smoking cessation, social support, positive effect, online social networking, theory-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WeChat interactive peer support group | Experimental | Behavioral: Basic health education messages, Behavioral: WeChat interactive peer support groupParticipants 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 | Active comparator | Behavioral: Basic health education messagesMembers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Physically or mentally unfit
- Having participated in smoking cessation programs (last six months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic health education messagesMessages 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. | Behavioural | Basic health education messages, WeChat interactive peer support group |
| WeChat interactive peer support groupParticipants 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. | Behavioural | WeChat interactive peer support group |
Primary outcome
Self-reported 7-day point prevalence (pp) quit rate
Time frame: 6 months
Self-reported 7-day point prevalence (pp) quit rate of smokers at 6 months post end-of-intervention
5 secondary outcomes
Number of cigarettes consumed per day as compared to that of the baseline
Time frame: 6 months
Positive and Negative Affect Scale score
Time frame: 6 months
Smoking Self-Efficacy Questionnaire score
Time frame: 6 months
Subjective Norms Scale score
Time frame: 6 months
Attitude Towards Smoking Scale score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zixin Wang, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic health education messages and WeChat interactive peer support group in people with Self Efficacy and Health Behavior, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 7-day point prevalence (pp) quit rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.