Tobacco Use CessationM2Q2NCT03567993
mHealth Messaging to Motivate Quitline Use Quitting
A study testing Comparison and Intervention in people with Tobacco Use Cessation, run by University of Massachusetts, Worcester at 1 site in Vietnam.
Trial summary
The mHealth Messaging to Motivate Quitline Use and Quitting, or "M2Q2" study, is a collaborative research project for a mobile health intervention designed to motivate smoking cessation and encourage access to counseling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Comparison and Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Nov 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age.
- Resident of a selected commune.
- Be a current smoker.
- Be able to receive texts and read text (literate).
- Not be cognitively impaired (as assessed by study staff).
- Not have helped develop messages used in the intervention.
- Not be a family member of another participant in the study.
Who cannot join
- <18 years of age.
- Cognitively impaired (as assessed by study staff).
- Pregnant.
- Prisoner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth Messaging to Motivate Quitline Use and Quitting (M2Q2): RCT in Rural Vietnam
The mHealth Messaging to Motivate Quitline Use and Quitting, or "M2Q2" study, is a collaborative research project for a mobile health intervention designed to motivate smoking cessation and encourage access to counseling. The study is for men and women smokers in Vietnam's Red River Delta region who are 18 years of age or older.
The primary hypothesis is that smokers in the M2Q2 intervention will have higher rates of smoking cessation, compared with the comparison group.
Read the detailed description
The specific aims of the M2Q2 study are:
Aim 1: In collaboration with the Institute of Population, Health, and Development (PHAD) in Vietnam, adapt a current, effective messaging system to Vietnam. The messaging system will:
- Motivate smokers to quit smoking, using tailored messages adapted to be culturally relevant.
- Encourage smokers to accept counseling services from the Quitline, and take advantage of nicotine replacement therapy (NRT) that will be provided by the Quitline to those willing to quit.
Aim 2: To engage with the Quitline, providing additional training in tobacco cessation counseling for those ready to quit, and motivational interventions for those not yet ready to quit.
Aim 3: To evaluate the impact of the messaging system on: access to the Quitline, use of nicotine replacement therapy, increase in self-efficacy, and six-month biochemically verified smoking cessation.
The study will be conducted in the Red River Delta Region, an agriculturally rich and densely populated area in northern Vietnam. Four communes (Viet Hung, Binh Minh, Tan Viet and Bach Sam) located in four different districts in the Hung Yen province will be included in the M2Q2 study, based on their general representativeness to the rural northern Vietnamese population and because the investigators have developed infrastructure to support technology-assisted behavioral interventions through community health centers (CHCs) in these communes. Each of the selected communes satisfy the following criteria: (1) have a community health center with a medical doctor; (2) are not currently participating in other studies for smoking cessation; and (3) have a minimum geographic separation of 12 kilometers (7 miles) from all other study communes to minimize possible contamination.
Recruitment and retention of study participants will be conducted by both CHC staff and community health workers. The investigators will recruit men and women, and plan for recruiting 15% women. The investigators will plan to recruit smokers regardless of their readiness to quit. Participants will not be compensated, other than being provided a cellphone if they currently do not own one.
The duration of an individual subject's participation in the study is 6 months (baseline survey, texting system, quitline data, and the 6-month follow-up survey). The duration anticipated to enroll all study subjects is 2 years, 2 months. The estimated date for the investigators to complete this study with primary analyses is the middle of year 5.
The main dependent variable is patient tobacco cessation rate (quit rate) at six months. The investigators will biochemically verify smoking status at baseline and at six months. The secondary outcome measure is self-efficacy. The investigators will administer an 12-item questionnaire (SEQ-12) to measure self-efficacy at baseline and at six months.
- Conditions
- Tobacco Use Cessation
- Being tested
- Comparison, Intervention
- Keywords
- mhealth, Tobacco cessation, Vietnam, Smoking cessation
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComparisonBehavioural
Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.
InterventionBehavioural
Also called mHealth Intervention
Participants randomized to the intervention arm will receive:
- Motivational Messages
- Abstinence and Motivation to Use Services Assessments
- Encouragement to access the Quitline
- Encouragement to use Nicotine Replacement Therapy (NRT)
- Provision of NRT, if requested
Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT.
| Study group | Role | What they receive |
|---|---|---|
| Comparison | Active comparator | The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Receives: Behavioral: Comparison |
| Intervention | Experimental | The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Tobacco Cessation Rate (Quit Rate) at 6 Months
7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.
Measured: At 6 months post-randomization
Secondary outcomes (1)
Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)
Study team will administer the Self Efficacy Questionnaire (SEQ-12), an 12-item questionnaire to measure self-reported confidence of current and former smokers in their ability to abstain from smoking in high-risk situations (e.g., when facing internal stimuli (e.g., feeling depressed) and external stimuli (e.g., being with smokers)). The SEQ-12 consists of 12 items; each item is rated on a 5-point Likert scale (1=not at all sure, 2=not very sure, 3=more or less sure, 4=fairly sure, and 5=absolutely sure). SEQ-12 scores range from 12 to 60, with higher scores indicating greater self-efficacy. Individual items are summed to compute the total score. The outcome will measure the change in SEQ-12 scores from baseline to 6 months post-randomization.
Measured: From randomization to 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start23 Nov 2018
- Primary completion8 Apr 2021
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Population, Health and Development, Vietnam, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Rajani Sadasivam, University of Massachusetts, Worcester
- Investigators
- Rajani S Sadasivam, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567993
- Sponsor's protocol ID
- H00012953
- Other IDs
- R01TW010647
- Acronym
- M2Q2
- Status last verified
- Jan 2024
- First submitted
- 25 May 2018
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to other researchers.
Publications
Larkin C, Wijesundara J, Nguyen HL, Ha DA, Vuong A, Nguyen CK, Amante D, Ngo CQ, Phan PT, Pham QTL, Nguyen BN, Nguyen ATP, Nguyen PTT, Person S, Allison JJ, Houston TK, Sadasivam R. mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam. JMIR Res Protoc. 2021 Oct 7;10(10):e30947. doi: 10.2196/30947.
PubMed 34617915
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Messaging to Motivate Quitline Use and Quitting (M2Q2): RCT in Rural Vietnam
- ClinicalTrials.gov ID
- NCT03567993
- Acronym / sponsor ID
- M2Q2 / H00012953
- Conditions
- Tobacco Use Cessation
- Keywords
- mhealth, Tobacco cessation, Vietnam, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Institute of Population, Health and Development, Vietnam, National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mHealth Messaging to Motivate Quitline Use and Quitting, or "M2Q2" study, is a collaborative research project for a mobile health intervention designed to motivate smoking cessation and encourage access to counseling. The study is for men and women smokers in Vietnam's Red River Delta region who are 18 years of age or older.
The primary hypothesis is that smokers in the M2Q2 intervention will have higher rates of smoking cessation, compared with the comparison group.
Detailed description
The specific aims of the M2Q2 study are:
Aim 1: In collaboration with the Institute of Population, Health, and Development (PHAD) in Vietnam, adapt a current, effective messaging system to Vietnam. The messaging system will:
- Motivate smokers to quit smoking, using tailored messages adapted to be culturally relevant.
- Encourage smokers to accept counseling services from the Quitline, and take advantage of nicotine replacement therapy (NRT) that will be provided by the Quitline to those willing to quit.
Aim 2: To engage with the Quitline, providing additional training in tobacco cessation counseling for those ready to quit, and motivational interventions for those not yet ready to quit.
Aim 3: To evaluate the impact of the messaging system on: access to the Quitline, use of nicotine replacement therapy, increase in self-efficacy, and six-month biochemically verified smoking cessation.
The study will be conducted in the Red River Delta Region, an agriculturally rich and densely populated area in northern Vietnam. Four communes (Viet Hung, Binh Minh, Tan Viet and Bach Sam) located in four different districts in the Hung Yen province will be included in the M2Q2 study, based on their general representativeness to the rural northern Vietnamese population and because the investigators have developed infrastructure to support technology-assisted behavioral interventions through community health centers (CHCs) in these communes. Each of the selected communes satisfy the following criteria: (1) have a community health center with a medical doctor; (2) are not currently participating in other studies for smoking cessation; and (3) have a minimum geographic separation of 12 kilometers (7 miles) from all other study communes to minimize possible contamination.
Recruitment and retention of study participants will be conducted by both CHC staff and community health workers. The investigators will recruit men and women, and plan for recruiting 15% women. The investigators will plan to recruit smokers regardless of their readiness to quit. Participants will not be compensated, other than being provided a cellphone if they currently do not own one.
The duration of an individual subject's participation in the study is 6 months (baseline survey, texting system, quitline data, and the 6-month follow-up survey). The duration anticipated to enroll all study subjects is 2 years, 2 months. The estimated date for the investigators to complete this study with primary analyses is the middle of year 5.
The main dependent variable is patient tobacco cessation rate (quit rate) at six months. The investigators will biochemically verify smoking status at baseline and at six months. The secondary outcome measure is self-efficacy. The investigators will administer an 12-item questionnaire (SEQ-12) to measure self-efficacy at baseline and at six months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison | Active comparator | Behavioral: ComparisonThe comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. |
| Intervention | Experimental | Behavioral: InterventionThe intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age.
- Resident of a selected commune.
- Be a current smoker.
- Be able to receive texts and read text (literate).
- Not be cognitively impaired (as assessed by study staff).
Key exclusion criteria (4 listed)
- <18 years of age.
- Cognitively impaired (as assessed by study staff).
- Pregnant.
- Prisoner.
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 |
|---|---|---|
| ComparisonParticipants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention. | Behavioural | Comparison |
| InterventionAlso: mHealth InterventionParticipants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT. | Behavioural | Intervention |
Primary outcome
Participant Tobacco Cessation Rate (Quit Rate) at 6 Months
Time frame: At 6 months post-randomization
7 day point prevalence cessation per self-report with additional carbon monoxide monitor verification for those who report cessation.
1 secondary outcome
Change in Self-efficacy Scores Using the Self Efficacy Questionnaire (SEQ-12)
Time frame: From randomization to 6 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34617915Larkin C, Wijesundara J, Nguyen HL, Ha DA, Vuong A, Nguyen CK, Amante D, Ngo CQ, Phan PT, Pham QTL, Nguyen BN, Nguyen ATP, Nguyen PTT, Person S, Allison JJ, Houston TK, Sadasivam R. mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam. JMIR Res Protoc. 2021 Oct 7;10(10):e30947. doi: 10.2196/30947.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers.
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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.
Rajani S Sadasivam, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison and Intervention in people with Tobacco Use Cessation, run by University of Massachusetts, Worcester 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 7 inclusion and 4 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 14 Feb 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?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participant Tobacco Cessation Rate (Quit Rate) at 6 Months (time frame: At 6 months post-randomization). 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 NCT03567993, 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 14 Feb 2024.