- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06228976
Mindfulness-based, Mobile Health (mHealth) Smoking Cessation Intervention in Vietnam
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Minh V Hoang, PhD
- Phone Number: +84913392717
- Email: hvm@huph.edu.vn
Study Locations
-
-
-
Hanoi, Vietnam
- Recruiting
- Hanoi University of Public Health
-
Contact:
- Thao TP Tran, PhD
- Email: ttpt@huph.edu.vn
-
Contact:
- Van M Nguyen, MSc
- Phone Number: +84386815959
- Email: nmv@huph.edu.vn
-
Principal Investigator:
- Minh V Hoang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
One or two tailored messages will be sent to participants everyday at designated time for 12 weeks
|
Participants will receive mindfulness-based, smoking cessation focused text messages everyday for 12 weeks.
|
Active Comparator: Education Arm
One tailored message will be sent to participants everyday at designated time for 12 weeks
|
Text messages focus on the health risks of smoking and secondhand smoking, once everyday for 12 weeks.
|
Active Comparator: Control arm
One tailored message will be sent to participants everyday at designated time for 12 weeks
|
Text messages focus on the general healthy lifestyle, once everyday for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 12 weeks, at 16 weeks and 36 weeks
|
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
|
At 12 weeks, at 16 weeks and 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge about health risks of smoking and secondhand smoking
Time Frame: At 12 weeks, at 16 weeks and 36 weeks
|
The participants will answer whether smoking caused certain diseases or not.
|
At 12 weeks, at 16 weeks and 36 weeks
|
Stage of change
Time Frame: At 12 weeks, at 16 weeks and 36 week
|
The participants will be asked about readiness to quit smoking, and when do the participants plan to quit smoking.
|
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
|
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.
|
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
|
The participant will be asked about abstaining from smoking in positive affect/social, negative affect, and habitual/craving situations
|
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
|
The participants will be asked about number of cigarettes smoked per day
|
At 12 weeks, at 16 weeks and 36 weeks
|
Nicotine dependency
Time Frame: At 12 weeks, at 16 weeks and 36 weeks
|
The participant's nicotine dependency will be assessed using the Fagerstrom Test for Nicotine Dependence
|
At 12 weeks, at 16 weeks and 36 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- mhealthVN01
- 5R01TW010666-05 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
Columbia UniversityNational Cancer Institute (NCI)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking BehaviorsUnited States
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Maastricht University Medical CenterThe Investigative Desk; SEO Amsterdam Economics; IVO Research InstituteEnrolling by invitationSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsNetherlands
-
Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
-
Medical University of South CarolinaRecruitingSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Ghana Health ServicesKwame Nkrumah University of Science and TechnologyNot yet recruitingSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking Behaviors
Clinical Trials on Mindfulness-based, smoking cessation focused text messages.
-
The Miriam HospitalLive Inspired, LLCCompletedTobacco Use Disorder | Nicotine DependenceUnited States
-
Boston UniversityNational Institute of Dental and Craniofacial Research (NIDCR)Recruiting
-
George Washington UniversityWithdrawn
-
Brown UniversityTruth InitiativeCompletedAlcohol Drinking | Smoking CessationUnited States
-
University of VirginiaCompleted
-
The University of Hong KongCompletedSmoking CessationHong Kong
-
Yale UniversityCompletedSmoking Cessation | Tobacco Smoking | Nicotine Dependence | Cigarette SmokingUnited States
-
The University of Texas Health Science Center at...Cancer Prevention Research Institute of Texas; The University of Texas at San...Not yet recruiting
-
Oregon Research Behavioral Intervention Strategies...RecruitingTobacco UseUnited States