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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219541
• Other study ID #: 17-00630
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: March 13, 2019

Study information

• Verified date: April 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Interventional Automated mobile phone text
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.
• Control Automated mobile phone text
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Acceptability	Measured by ranking the mean score of each message	12 Weeks
Secondary	Number of quit attempts	Measured using the 12-item Cigarette Dependence Scale (CDS)	12 Weeks
Secondary	Percentage of respondents who have made at least one quit attempt during the intervention period,	Measured using the Smoking Absitinence Questionnaire (SAQ)	12 Weeks
Secondary	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