SmokingNCT03219541
Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam
A study testing Interventional Automated mobile phone text in people with Smoking, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Interventional Automated mobile phone text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 13 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Under smoking cessation treatment or is participating in other tobacco cessation intervention
- pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Interventional Automated mobile phone text, Control Automated mobile phone text
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Automated mobile phone textBehavioural
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 textBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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?" Receives: 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. Receives: Behavioral: Control Automated mobile phone text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
Measured by ranking the mean score of each message
Measured: 12 Weeks
Secondary outcomes (3)
Number of quit attempts
Measured using the 12-item Cigarette Dependence Scale (CDS)
Measured: 12 Weeks
Percentage of respondents who have made at least one quit attempt during the intervention period,
Measured using the Smoking Absitinence Questionnaire (SAQ)
Measured: 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)
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start5 Feb 2018
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Shelley, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219541
- Sponsor's protocol ID
- 17-00630
- Status last verified
- Apr 2020
- First submitted
- 6 Jul 2017
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34623318
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam
- ClinicalTrials.gov ID
- NCT03219541
- Acronym / sponsor ID
- 17-00630
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Automated mobile phone text | Active comparator | Behavioral: Interventional Automated mobile phone textSubjects 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?" |
| Control Texts | Placebo comparator | Behavioral: Control Automated mobile phone textThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Under smoking cessation treatment or is participating in other tobacco cessation intervention
- pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional Automated mobile phone textParticipants 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. | Behavioural | Interventional Automated mobile phone text |
| Control Automated mobile phone textParticipants 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. | Behavioural | Control Texts |
Primary outcome
Intervention Acceptability
Time frame: 12 Weeks
Measured by ranking the mean score of each message
3 secondary outcomes
Number of quit attempts
Time frame: 12 Weeks
Percentage of respondents who have made at least one quit attempt during the intervention period,
Time frame: 12 Weeks
Percent decrease in cigarette consumption per day at 2- and 4-week follow-ups compared to baseline
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Derived from this study: PubMed 34623318Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Shelley principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Automated mobile phone text in people with Smoking, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.