Pictorial Health WarningsNCT06818786
Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors
A study testing Branded pack with new PHWs covering 50% of the pack without quitline information, Branded pack with new PHWs covering 85% of the pack without quitline information and Branded pack with new PHWs covering 85% of the pack with quitline information in people with Pictorial Health Warnings, run by Georgia State University at 1 site in Vietnam.
Trial summary
This proposed study will assess the effects of different scenarios of PHW policies on smokers' reactions to warnings, attitudes and beliefs, behavioral intentions, and quitting behaviors, with specific aims: 1) to assess the impact of new PHWs covering 50% of cigarette packs, 2) to assess the impact of new larger PHWs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pictorial Health Warnings
- What is being tested?
- Branded pack with new PHWs covering 50% of the pack without quitline information, Branded pack with new PHWs covering 85% of the pack without quitline information and Branded pack with new PHWs covering 85% of the pack with quitline information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 1 siteVietnam
- Study dates
- 24 Aug 2024to 8 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having smoked at least 100 cigarettes in their lifetime and currently smoking
- aged 18 or older
- fluent in Vietnamese
- smartphone users
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors: A Randomized Controlled Trial
This proposed study will assess the effects of different scenarios of PHW policies on smokers' reactions to warnings, attitudes and beliefs, behavioral intentions, and quitting behaviors, with specific aims: 1) to assess the impact of new PHWs covering 50% of cigarette packs, 2) to assess the impact of new larger PHWs covering 85% of cigarette packs, 3) to assess the impact of incorporating quitline information on cigarette packs, and 4) to assess the impact of plain packaging. These aims will be achieved by conducting a five-arm RCT among 1000 adult smokers (n=200 per arm). It includes four intervention groups: 1) branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information, 2) branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information, 3) branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information, and 4) plain pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information. A control group will use branded packs with the current set of 6 PHWs, covering 50% of cigarette packs without quitline information.
Given that the pictorial health warnings (PHW) on cigarette packs need to be renewed, this project will provide highly policy-relevant and timely scientific evidence on the effect of new PHW policies in Vietnam. Additionally, this project would be the first to address the research gap in understanding the effect of adding quitline information to PHWs-a gap not explored in previous studies. With the potential for significant outcomes, the findings will help Vietnamese policymakers enact stronger PHW policies in upcoming years, aiming to increase perceived harms of smoking and foster smoking cessation, ultimately saving millions of lives in Vietnam
- Conditions
- Pictorial Health Warnings
- Being tested
- Branded pack with new PHWs covering 50% of the pack without quitline information, Branded pack with new PHWs covering 85% of the pack without quitline information, Branded pack with new PHWs covering 85% of the pack with quitline information, Plain pack with new PHWs covering 85% of the pack with quitline information, Branded pack with the current set of PHWs covering 50% of the pack without quitline information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branded pack with new PHWs covering 50% of the pack without quitline informationOther
Participants received and were required to view six images depicting a branded cigarette pack with a new set of six pictorial health warnings covering 50% of the pack, without quitline information.
Branded pack with new PHWs covering 85% of the pack without quitline informationOther
Participants received and were required to view six images depicting a branded cigarette pack with a new set of six pictorial health warnings covering 85% of the pack, without quitline information.
Branded pack with new PHWs covering 85% of the pack with quitline informationOther
Participants received and were required to view six images depicting a branded cigarette pack with a new set of six pictorial health warnings covering 85% of the pack, with quitline information
Plain pack with new PHWs covering 85% of the pack with quitline informationOther
Participants received and were required to view six images depicting a plain cigarette pack with a new set of six pictorial health warnings covering 85% of the pack, with quitline information
Branded pack with the current set of PHWs covering 50% of the pack without quitline informationOther
Participants received and were required to view 6 images depicting a branded cigarette pack with a current set of 6 pictorial health warnings covering 50% of cigarette packs without quitline information (It is the current pictorial health warnings implemented in Vietnam)
| Study group | Role | What they receive |
|---|---|---|
| Branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information | Experimental | Not described Receives: Other: Branded pack with new PHWs covering 50% of the pack without quitline information |
| Branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information | Experimental | Not described Receives: Other: Branded pack with new PHWs covering 85% of the pack with quitline information |
| Branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information | Experimental | Not described Receives: Other: Branded pack with new PHWs covering 85% of the pack without quitline information |
| Plain pack with new PHWs covering 85% of the pack with quitline information | Experimental | Not described Receives: Other: Plain pack with new PHWs covering 85% of the pack with quitline information |
| Branded pack with the current set of PHWs covering 50% of the pack without quitline information | Active comparator | Not described Receives: Other: Branded pack with the current set of PHWs covering 50% of the pack without quitline information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional and cognitive responses
Negative emotions, including sadness, anger, fear, guilt, disgust, worry, and shame, were measured on a scale from 1 (not at all) to 9 (extremely).
Perceived message effectiveness was assessed using the following statements:
"This warning discourages me from wanting to smoke." "This warning makes smoking seem unpleasant to me." "This warning makes me concerned about the health effects of smoking." Participants rated their agreement on a scale from 1 (strongly disagree) to 7 (strongly agree), with an additional "don't know" option.
Measured: At the enrollment
Secondary outcomes (3)
Attitudes and beliefs
Health risk perceptions were assessed using the following questions:
"If you were to smoke cigarettes every day, how likely is it that they would harm your overall health?" "If you were to smoke cigarettes every day, how likely is it that you would get addicted?" Participants rated their responses on a scale from 1 (not at all likely) to 5 (extremely likely), with an additional "don't know" option.
Health-related beliefs were assessed using the following statements:
"Tobacco smoke is dangerous for non-smokers' health." "Smoking causes lung cancer." "Smoking causes oral cancer." "Smoking causes bleeding in the brain and stroke." "Smoking causes neck cancer." Participants rated their agreement on a scale from 1 (strongly disagree) to 7 (strongly agree), with an additional "don't know" option.
Measured: At the enrollment
Behavioral intentions
Behavioral intentions were assessed using the following questions:
Quit motivation: "How motivated are you to quit smoking in the next month?" Quit intention: "How likely are you to quit smoking in the next month?" Quitline call intention: "How likely are you to call the quitline in the next month?" Participants rated their responses on a scale from 1 (not at all) to 9 (extremely).
Measured: At the enrollment
Recall and behavioral outcomes at 2-week follow-up
This study assessed various recall and behavioral outcomes at 2 -week follow-up, including whether participants had thought about the harms of smoking, recalled the national quitline number, engaged in communication behaviors related to smoking and quitting, forwent cigarettes due to harm-related thoughts, made a quit attempt, or reduced the number of cigarettes smoked per day after 2 weeks. All outcomes were recorded as binary (Yes/No).
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start24 Aug 2024
- Primary completion24 Sep 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pictorial Health WarningsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi University of Public Health
- Responsible party
- Principal investigator, Thi Phuong Thao Tran, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818786
- Sponsor's protocol ID
- H25022
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06818786
- Acronym / sponsor ID
- H25022
- Conditions
- Pictorial Health Warnings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Hanoi University of Public Health
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 10 Feb 2025 (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.
This proposed study will assess the effects of different scenarios of PHW policies on smokers' reactions to warnings, attitudes and beliefs, behavioral intentions, and quitting behaviors, with specific aims: 1) to assess the impact of new PHWs covering 50% of cigarette packs, 2) to assess the impact of new larger PHWs covering 85% of cigarette packs, 3) to assess the impact of incorporating quitline information on cigarette packs, and 4) to assess the impact of plain packaging. These aims will be achieved by conducting a five-arm RCT among 1000 adult smokers (n=200 per arm). It includes four intervention groups: 1) branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information, 2) branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information, 3) branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information, and 4) plain pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information. A control group will use branded packs with the current set of 6 PHWs, covering 50% of cigarette packs without quitline information.
Given that the pictorial health warnings (PHW) on cigarette packs need to be renewed, this project will provide highly policy-relevant and timely scientific evidence on the effect of new PHW policies in Vietnam. Additionally, this project would be the first to address the research gap in understanding the effect of adding quitline information to PHWs-a gap not explored in previous studies. With the potential for significant outcomes, the findings will help Vietnamese policymakers enact stronger PHW policies in upcoming years, aiming to increase perceived harms of smoking and foster smoking cessation, ultimately saving millions of lives in Vietnam
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information | Experimental | Other: Branded pack with new PHWs covering 50% of the pack without quitline information |
| Branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information | Experimental | Other: Branded pack with new PHWs covering 85% of the pack with quitline information |
| Branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information | Experimental | Other: Branded pack with new PHWs covering 85% of the pack without quitline information |
| Plain pack with new PHWs covering 85% of the pack with quitline information | Experimental | Other: Plain pack with new PHWs covering 85% of the pack with quitline information |
| Branded pack with the current set of PHWs covering 50% of the pack without quitline information | Active comparator | Other: Branded pack with the current set of PHWs covering 50% of the pack without quitline information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having smoked at least 100 cigarettes in their lifetime and currently smoking
- aged 18 or older
- fluent in Vietnamese
- smartphone users
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Branded pack with new PHWs covering 50% of the pack without quitline informationParticipants received and were required to view six images depicting a branded cigarette pack with a new set of six pictorial health warnings covering 50% of the pack, without quitline information. | Other | Branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information |
| Branded pack with new PHWs covering 85% of the pack without quitline informationParticipants received and were required to view six images depicting a branded cigarette pack with a new set of six pictorial health warnings covering 85% of the pack, without quitline information. | Other | Branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information |
| Branded pack with new PHWs covering 85% of the pack with quitline informationParticipants received and were required to view six images depicting a branded cigarette pack with a new set of six pictorial health warnings covering 85% of the pack, with quitline information | Other | Branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information |
| Plain pack with new PHWs covering 85% of the pack with quitline informationParticipants received and were required to view six images depicting a plain cigarette pack with a new set of six pictorial health warnings covering 85% of the pack, with quitline information | Other | Plain pack with new PHWs covering 85% of the pack with quitline information |
| Branded pack with the current set of PHWs covering 50% of the pack without quitline informationParticipants received and were required to view 6 images depicting a branded cigarette pack with a current set of 6 pictorial health warnings covering 50% of cigarette packs without quitline information (It is the current pictorial health warnings implemented in Vietnam) | Other | Branded pack with the current set of PHWs covering 50% of the pack without quitline information |
Primary outcome
Emotional and cognitive responses
Time frame: At the enrollment
Negative emotions, including sadness, anger, fear, guilt, disgust, worry, and shame, were measured on a scale from 1 (not at all) to 9 (extremely). Perceived message effectiveness was assessed using the following statements: "This warning discourages me from wanting to smoke." "This warning makes smoking seem unpleasant to me." "This warning makes me concerned about the health effects of smoking." Participants rated their agreement on a scale from 1 (strongly disagree) to 7 (strongly agree), with an additional "don't know" option.
3 secondary outcomes
Attitudes and beliefs
Time frame: At the enrollment
Behavioral intentions
Time frame: At the enrollment
Recall and behavioral outcomes at 2-week follow-up
Time frame: at 2 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 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branded pack with new PHWs covering 50% of the pack without quitline information, Branded pack with new PHWs covering 85% of the pack without quitline information and Branded pack with new PHWs covering 85% of the pack with quitline information in people with Pictorial Health Warnings, run by Georgia State University 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 4 inclusion and 1 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 12 Feb 2025. 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?
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?
Emotional and cognitive responses (time frame: At the enrollment). 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 12 Feb 2025.