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Completed

NCT Number: NCT03219541

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.

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Key information

Conditions

Smoking Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interventional Automated mobile phone text

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Intervention Acceptability

    Time frame: 12 Weeks

    Measured by ranking the mean score of each message

Secondary outcomes

  1. Number of quit attempts

    Time frame: 12 Weeks

    Measured using the 12-item Cigarette Dependence Scale (CDS)

  2. Percentage of respondents who have made at least one quit attempt during the intervention period,

    Time frame: 12 Weeks

    Measured using the Smoking Absitinence Questionnaire (SAQ)

  3. Percent decrease in cigarette consumption per day at 2- and 4-week follow-ups compared to baseline

    Time frame: 4 Weeks

    Measured using the Smoking Absitinence Questionnaire (SAQ)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2017
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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