Smoking CessationNCT06228976
Mindfulness-based, Mobile Health (mHealth) Smoking Cessation Intervention in Vietnam
A study testing Mindfulness-based, smoking cessation focused text messages. and Educational messages in people with Smoking Cessation and Mindfulness, run by Hanoi University of Public Health at 1 site in Vietnam.
Trial summary
The goals of this a three-arm randomized controlled trial (RCT) is to evaluate the efficacy of mindfulness-based, culturally appropriate, and mobile phone-based smoking cessation intervention among Vietnamese adult male smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Mindfulness, Telemedicine
- What is being tested?
- Mindfulness-based, smoking cessation focused text messages. and Educational messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteVietnam
- Study dates
- 27 Aug 2023to Dec 2024
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current cigarette smokers (irrespective of the person's current intention to quit) who are living in the 6 communes in Hai Duong province
- Ability to read and write in Vietnamese
- Ownership of a cell phone and knowledge/ability to send and receive text messages
- Do not have any plan to relocate in the next year
- Agree to receive text messages for 12 weeks
- Agree to be contacted by the research team for follow-ups interviews
Who cannot join
- Do not agree to participate in the study
- Have serious chronic illnesses or injuries that affect reading and comprehension
- Cannot participate in the intervention activities during the proposed intervention period
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi University of Public Health
Hanoi
Thao TP Tran, PhD, ttpt@huph.edu.vn
Van M Nguyen, MSc, +84386815959, nmv@huph.edu.vn
About this study
Official title: A Randomized Controlled Trial Exploring Mindfulness-based Smoking Cessation Intervention Using Mobile Technology in Vietnam
The goals of this a three-arm randomized controlled trial (RCT) is to evaluate the efficacy of mindfulness-based, culturally appropriate, and mobile phone-based smoking cessation intervention among Vietnamese adult male smokers.
The intervention will be delivered via text messages, involving 1,200 adult male smokers, with 400 participants in each of three intervention arms (Cessation Intervention - culturally-adapted smoking cessation messages that incorporate mindfulness; Education Intervention - messages that solely focus on health risks of smoking; Control - basic messages that solely focus on general healthy lifestyle). The investigator will assess cessation rates up to 6-month follow-up, as well as secondary outcomes of knowledge of smoking health risks; stages of change; quit attempts; self-efficacy; cigarettes per day; and nicotine dependence. The investigators hypothesize that participants in the Cessation Intervention group (who will receive culturally-adapted messages) will have higher rates of smoking abstinence, greater knowledge of the health risks of smoking, more transitions from pre-contemplation/contemplation stages to planning/action stages, higher likelihood of making a quit attempt, higher self-efficacy for abstaining from smoking, greater reductions in cigarette consumption, and lower nicotine dependence, compared to participants in the Education Intervention group and Control group.
Read the detailed description
Cessation Intervention: Participants in the Cessation Intervention group will be divided into two groups (have intention to quit vs. not have intention to quit) based on the participants' stage of change (Transtheoretical Model) [1] at baseline assessment to receive different message libraries during the 12 week intervention. Participants who have intention to quit (at the action or preparation stage of change) will set the quit date at time of enrollment to the study. The two weeks before the quit date, participants will receive 2 messages per day with content focusing on health benefits of quitting, monetary costs of smoking, encouragement and some tips/strategies to prepare for the quit date. Two days around the quit date, participants will receive 3-4 messages per day, and the first five weeks participants will receive 2 messages per day. The content of messages in the first five weeks after the quit date is diverse, providing participants a lot of tips/strategies (including mindfulness practice) to deal with cravings/withdrawal symptoms, benefits of quitting, interactive messages asking the participants' mood and craving levels, motivating messages and encouraging to get supports from family/friends and other smoking cessation resources (i.e., quit line, website). During this period, participants will periodically be asked about maintain smoke-free, and based on the particpants' answer, further messages will provide encouragement to get back on track or stay focus to avoid relapse. From week 6 to week 12, participants will just receive one message per day, with content covers benefits of quitting smoking, motivating messages, tips to avoid cravings/relapse, and interactive messages asking about the participants' smoke free status. Participants who do not have intention to quit will receive messages from another library, with the frequency of one message per day throughout 12 weeks of the intervention. This message library will provide participants knowledge of negative effects of smoking with specific evidences, benefits of quitting, encouraging messages as well as messages to increase the participants self-efficacy in quitting smoking. From week 2 to week 7, participants in this group will receive an interactive message on every 7-day period, asking if the participants want to set a quit date in the next week. If participants answer yes to the question, the participants will be switch to the message library for those who have intention to quit as mentioned above.
Education Intervention Group and Control Group: Participants in the Education Intervention and Control groups will also receive one single message per day for the entire 12-week intervention period. Education Intervention messages will specifically focus on the health risks of smoking and secondhand smoking (i.e., education about health risks, without providing specific strategies for quitting). These messages will be taken from the text message library developed by NCI, and will be directly translated into Chinese and Vietnamese without cultural adaptions. Control messages will provide general health education (not including smoking), including promoting fruit and vegetable intake and low sodium intake; encouraging physical activity; and avoiding drug use/excess alcohol use. These messages will be translated from previous studies that use mHealth approaches to promote healthy lifestyles.
- Conditions
- Smoking Cessation, Mindfulness, Telemedicine, Smoking
- Being tested
- Mindfulness-based, smoking cessation focused text messages., Educational messages, Control messages
- Keywords
- smoking cessation, smoking behavior, Mindfulness-based, randomized controlled trial, Vietnam, mobile health
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based, smoking cessation focused text messages.Behavioural
Participants will receive mindfulness-based, smoking cessation focused text messages everyday for 12 weeks.
Educational messagesBehavioural
Text messages focus on the health risks of smoking and secondhand smoking, once everyday for 12 weeks.
Control messagesBehavioural
Text messages focus on the general healthy lifestyle, once everyday for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | One or two tailored messages will be sent to participants everyday at designated time for 12 weeks Receives: Behavioral: Mindfulness-based, smoking cessation focused text messages. |
| Education Arm | Active comparator | One tailored message will be sent to participants everyday at designated time for 12 weeks Receives: Behavioral: Educational messages |
| Control arm | Active comparator | One tailored message will be sent to participants everyday at designated time for 12 weeks Receives: Behavioral: Control messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence smoking abstinence
Whether the participant smoked cigarette at all, even a puff, in the last 7 days
Measured: At 12 weeks, at 16 weeks and 36 weeks
30-day point prevalence smoking abstinence
Whether the participant smoked cigarette at all, even a puff, in the last 30 days
Measured: At 12 weeks, at 16 weeks and 36 weeks
Secondary outcomes (6)
Knowledge about health risks of smoking and secondhand smoking
The participants will answer whether smoking caused certain diseases or not.
Measured: At 12 weeks, at 16 weeks and 36 weeks
Stage of change
The participants will be asked about readiness to quit smoking, and when do the participants plan to quit smoking.
Measured: At 12 weeks, at 16 weeks and 36 week
Quit attempts within the last 30 days
Number of quit attempts made that last longer than 01 day because the participant want to quit smoking. The duration of the longest quit attempt made in the last 30 days.
Measured: At 12 weeks, at 16 weeks and 36 weeks
Self-efficacy for abstaining from smoking
The participant will be asked about abstaining from smoking in positive affect/social, negative affect, and habitual/craving situations
Measured: At 12 weeks, at 16 weeks and 36 weeks
Number of cigarettes smoked per day
The participants will be asked about number of cigarettes smoked per day
Measured: At 12 weeks, at 16 weeks and 36 weeks
Nicotine dependency
The participant's nicotine dependency will be assessed using the Fagerstrom Test for Nicotine Dependence
Measured: At 12 weeks, at 16 weeks and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start27 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi University of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia State University, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Hoang Van Minh, Hanoi University of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228976
- Sponsor's protocol ID
- mhealthVN01
- Other IDs
- 5R01TW010666-05
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Exploring Mindfulness-based Smoking Cessation Intervention Using Mobile Technology in Vietnam
- ClinicalTrials.gov ID
- NCT06228976
- Acronym / sponsor ID
- mhealthVN01
- Conditions
- Smoking Cessation, Mindfulness, Telemedicine, Smoking
- Keywords
- smoking cessation, smoking behavior, Mindfulness-based, randomized controlled trial, Vietnam, mobile health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Hanoi University of Public HealthUniversity, hospital or other
- Collaborators
- Georgia State University, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 27 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Jan 2024 (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 goals of this a three-arm randomized controlled trial (RCT) is to evaluate the efficacy of mindfulness-based, culturally appropriate, and mobile phone-based smoking cessation intervention among Vietnamese adult male smokers.
The intervention will be delivered via text messages, involving 1,200 adult male smokers, with 400 participants in each of three intervention arms (Cessation Intervention - culturally-adapted smoking cessation messages that incorporate mindfulness; Education Intervention - messages that solely focus on health risks of smoking; Control - basic messages that solely focus on general healthy lifestyle). The investigator will assess cessation rates up to 6-month follow-up, as well as secondary outcomes of knowledge of smoking health risks; stages of change; quit attempts; self-efficacy; cigarettes per day; and nicotine dependence. The investigators hypothesize that participants in the Cessation Intervention group (who will receive culturally-adapted messages) will have higher rates of smoking abstinence, greater knowledge of the health risks of smoking, more transitions from pre-contemplation/contemplation stages to planning/action stages, higher likelihood of making a quit attempt, higher self-efficacy for abstaining from smoking, greater reductions in cigarette consumption, and lower nicotine dependence, compared to participants in the Education Intervention group and Control group.
Detailed description
Cessation Intervention: Participants in the Cessation Intervention group will be divided into two groups (have intention to quit vs. not have intention to quit) based on the participants' stage of change (Transtheoretical Model) [1] at baseline assessment to receive different message libraries during the 12 week intervention. Participants who have intention to quit (at the action or preparation stage of change) will set the quit date at time of enrollment to the study. The two weeks before the quit date, participants will receive 2 messages per day with content focusing on health benefits of quitting, monetary costs of smoking, encouragement and some tips/strategies to prepare for the quit date. Two days around the quit date, participants will receive 3-4 messages per day, and the first five weeks participants will receive 2 messages per day. The content of messages in the first five weeks after the quit date is diverse, providing participants a lot of tips/strategies (including mindfulness practice) to deal with cravings/withdrawal symptoms, benefits of quitting, interactive messages asking the participants' mood and craving levels, motivating messages and encouraging to get supports from family/friends and other smoking cessation resources (i.e., quit line, website). During this period, participants will periodically be asked about maintain smoke-free, and based on the particpants' answer, further messages will provide encouragement to get back on track or stay focus to avoid relapse. From week 6 to week 12, participants will just receive one message per day, with content covers benefits of quitting smoking, motivating messages, tips to avoid cravings/relapse, and interactive messages asking about the participants' smoke free status. Participants who do not have intention to quit will receive messages from another library, with the frequency of one message per day throughout 12 weeks of the intervention. This message library will provide participants knowledge of negative effects of smoking with specific evidences, benefits of quitting, encouraging messages as well as messages to increase the participants self-efficacy in quitting smoking. From week 2 to week 7, participants in this group will receive an interactive message on every 7-day period, asking if the participants want to set a quit date in the next week. If participants answer yes to the question, the participants will be switch to the message library for those who have intention to quit as mentioned above.
Education Intervention Group and Control Group: Participants in the Education Intervention and Control groups will also receive one single message per day for the entire 12-week intervention period. Education Intervention messages will specifically focus on the health risks of smoking and secondhand smoking (i.e., education about health risks, without providing specific strategies for quitting). These messages will be taken from the text message library developed by NCI, and will be directly translated into Chinese and Vietnamese without cultural adaptions. Control messages will provide general health education (not including smoking), including promoting fruit and vegetable intake and low sodium intake; encouraging physical activity; and avoiding drug use/excess alcohol use. These messages will be translated from previous studies that use mHealth approaches to promote healthy lifestyles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Mindfulness-based, smoking cessation focused text messages.One or two tailored messages will be sent to participants everyday at designated time for 12 weeks |
| Education Arm | Active comparator | Behavioral: Educational messagesOne tailored message will be sent to participants everyday at designated time for 12 weeks |
| Control arm | Active comparator | Behavioral: Control messagesOne tailored message will be sent to participants everyday at designated time for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current cigarette smokers (irrespective of the person's current intention to quit) who are living in the 6 communes in Hai Duong province
- Ability to read and write in Vietnamese
- Ownership of a cell phone and knowledge/ability to send and receive text messages
- Do not have any plan to relocate in the next year
- Agree to receive text messages for 12 weeks
Key exclusion criteria (3 listed)
- Do not agree to participate in the study
- Have serious chronic illnesses or injuries that affect reading and comprehension
- Cannot participate in the intervention activities during the proposed intervention period
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 |
|---|---|---|
| Mindfulness-based, smoking cessation focused text messages.Participants will receive mindfulness-based, smoking cessation focused text messages everyday for 12 weeks. | Behavioural | Intervention Arm |
| Educational messagesText messages focus on the health risks of smoking and secondhand smoking, once everyday for 12 weeks. | Behavioural | Education Arm |
| Control messagesText messages focus on the general healthy lifestyle, once everyday for 12 weeks. | Behavioural | Control arm |
Primary outcome
7-day point prevalence smoking abstinence
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Whether the participant smoked cigarette at all, even a puff, in the last 7 days
30-day point prevalence smoking abstinence
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Whether the participant smoked cigarette at all, even a puff, in the last 30 days
6 secondary outcomes
Knowledge about health risks of smoking and secondhand smoking
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Stage of change
Time frame: At 12 weeks, at 16 weeks and 36 week
Quit attempts within the last 30 days
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Self-efficacy for abstaining from smoking
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Number of cigarettes smoked per day
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Nicotine dependency
Time frame: At 12 weeks, at 16 weeks and 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based, smoking cessation focused text messages. and Educational messages in people with Smoking Cessation and Mindfulness, run by Hanoi University of Public Health at 1 site in Vietnam.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. 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 Vietnam. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minh V Hoang, PhD (+84913392717, hvm@huph.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence smoking abstinence (time frame: At 12 weeks, at 16 weeks and 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.