Mindfulness-based, Mobile Health (mHealth) Smoking Cessation Intervention in Vietnam

NCT06228976 | Unknown DMC

• 2 other identifiers: mhealthVN015R01TW010666-05
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking Cessation; Mindfulness; Telemedicine; Smoking

Keywords

smoking cessation; smoking behavior; Mindfulness-based; randomized controlled trial; Vietnam; mobile health

Outcome Measures

Primary Outcomes (2)

• 7-day point prevalence smoking abstinence

  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

  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 Outcomes (6)

• Knowledge about health risks of smoking and secondhand smoking

  At 12 weeks, at 16 weeks and 36 weeks

• Stage of change

  At 12 weeks, at 16 weeks and 36 week

• Quit attempts within the last 30 days

  At 12 weeks, at 16 weeks and 36 weeks

• Self-efficacy for abstaining from smoking

  At 12 weeks, at 16 weeks and 36 weeks

• Number of cigarettes smoked per day

  At 12 weeks, at 16 weeks and 36 weeks

Study Arms (3)

Intervention Arm

EXPERIMENTAL

One or two tailored messages will be sent to participants everyday at designated time for 12 weeks

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

Behavioral: Educational messages

Control arm

ACTIVE COMPARATOR

One tailored message will be sent to participants everyday at designated time for 12 weeks

Behavioral: Control messages

Interventions

Mindfulness-based, smoking cessation focused text messages. BEHAVIORAL

Participants will receive mindfulness-based, smoking cessation focused text messages everyday for 12 weeks.

Intervention Arm

Educational messages BEHAVIORAL

Text messages focus on the health risks of smoking and secondhand smoking, once everyday for 12 weeks.

Education Arm

Control messages BEHAVIORAL

Text messages focus on the general healthy lifestyle, once everyday for 12 weeks.

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Biological male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanoi University of Public Health: lead
• Georgia State University: collaborator
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Hanoi University of Public Health

Hanoi, Vietnam

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Minh V Hoang, PhD

CONTACT

+84913392717; hvm@huph.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 29, 2024
• Study Start: August 27, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

VN (1)