Clinical trial NCT03219541: Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam
Official title: Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 190
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Acceptability
timeFrame: 12 Weeks
Secondary outcomes:
measure: Number of quit attempts
timeFrame: 12 Weeks
measure: Percentage of respondents who have made at least one quit attempt during the intervention period,
timeFrame: 12 Weeks
measure: Percent decrease in cigarette consumption per day at 2- and 4-week follow-ups compared to baseline
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Donna Shelley
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.