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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Interventional Automated mobile phone text; Behavioral: Control Automated mobile phone text

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional Automated mobile phone text; 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; 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.
Placebo Comparator: Control Texts; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Donna Shelley, NYU Langone Health

Publications and helpful links

General Publications

• Jiang N, Nguyen N, Siman N, Cleland CM, Nguyen T, Doan HT, Abroms LC, Shelley DR. Adaptation and Assessment of a Text Messaging Smoking Cessation Intervention in Vietnam: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Oct 8;9(10):e27478. doi: 10.2196/27478.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): March 13, 2019
• Study Completion (Actual): March 13, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17-00630

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No