NCT03219541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

July 6, 2017

Last Update Submit

April 16, 2020

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Intervention Acceptability

    Measured by ranking the mean score of each message

    12 Weeks

Secondary Outcomes (3)

  • Number of quit attempts

    12 Weeks

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

    12 Weeks

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

    4 Weeks

Study Arms (2)

Interventional Automated mobile phone text

ACTIVE COMPARATOR

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

Control Texts

PLACEBO COMPARATOR

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

Interventions

Interventional Automated mobile phone textBEHAVIORAL

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.

Interventional Automated mobile phone text
Control Automated mobile phone textBEHAVIORAL

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.

Control Texts

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Under smoking cessation treatment or is participating in other tobacco cessation intervention
  • pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 34623318DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Donna Shelley

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 17, 2017

Study Start

February 5, 2018

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

US(1)