Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam

Study Overview
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Brief Summary
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The purpose of this study is to develop and then test the feasibility, acceptability, and preliminary effect of a bidirectional text message smoking cessation intervention among Vietnamese smokers in Hanoi, Vietnam. The specific aim are: 1) To develop a smoking cessation text message library among Vietnamese smokers; 2) To evaluate message preferences, and the feasibility and acceptability of the bidirectional text message smoking cessation intervention; and 3) To assess the preliminary effect of a bidirectional mobile phone text message intervention on biochemically validated smoking abstinence.

Detailed Description
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For two-arm randomized control (RCT) pilot study (AIM 3), 100 current smokers will be observed to examine the preliminary effect of bidirectional SMS smoking cessation intervention. Subjects will be randomized into two groups (intervention vs. control), and compare the carbon monoxide (CO) validated 7-day point prevalence smoking abstinence rates at 4-week follow-up between intervention group (SMS smoking cessation treatment) and control group (assessment texts only). Investigators will administer surveys at baseline, 4- and 12-weeks, and assess daily cigarette consumption using text message surveys. After the intervention, they will randomly select 10 participants from the intervention group to attend semi-structured interviews to obtain more in-depth understanding about the usefulness, usability, and acceptability of the intervention. Findings from the pilot RCT will be used to derive an estimate of the effect size, power, and sample size for a full-scale efficacy trial.

Official Title
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Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Interventional Automated mobile phone text
* Behavioral: Control Automated mobile phone text


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoke ≥10 cigarettes per day capability to read and communicate plan to quit in the next 30 days has a mobile phone has experience using mobile phone text messaging during the past 6 months. Exclusion Criteria: Under smoking cessation treatment or is participating in other tobacco cessation intervention pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional Automated mobile phone text<br>Subjects will receive 2 messages per day in the pre-quit phase, 3 messages per day on the quit date and the first week in the post-quit phase, and 2 messages per day in the last 3 weeks of the intervention. During the intervention, participants will receive a text question at the end of every day asking you How many cigarettes have you smoked today? | Behavioral: Interventional Automated mobile phone text<br>* Participants will receive 2 messages per day in the pre-quit phase, 3 messages per day on the quit date and the first week in the post-quit phase, and 2 messages per day in the last 3 weeks of the intervention.<br>|
| Placebo Comparator: Control Texts<br>The intervention will consist of a 3-day pre-quit period and then a 4-week post-quit period. Participants will receive 2 text questions each week asking the number of smoking days in the past week and the average number of cigarette smoked per day. | Behavioral: Control Automated mobile phone text<br>* Participants will receive 2 text questions each week asking the number of smoking days in the past week and the average number of cigarette smoked per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability | Measured by ranking the mean score of each message | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of quit attempts | Measured using the 12-item Cigarette Dependence Scale (CDS) | 12 Weeks | 
| Percentage of respondents who have made at least one quit attempt during the intervention period, | Measured using the Smoking Absitinence Questionnaire (SAQ) | 12 Weeks | 
| Percent decrease in cigarette consumption per day at 2- and 4-week follow-ups compared to baseline | Measured using the Smoking Absitinence Questionnaire (SAQ) | 4 Weeks |