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Completed

NCT Number: NCT06818786

Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors

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

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Key information

Conditions

Pictorial Health Warnings

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi University of Public Health

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having smoked at least 100 cigarettes in their lifetime and currently smoking
  • aged 18 or older
  • fluent in Vietnamese
  • smartphone users

Exclusion criteria

-

Treatment and study plan

Branded pack with new PHWs covering 50% of the pack without quitline information

Other

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 information

Other

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 information

Other

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 information

Other

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 information

Other

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Attitudes and beliefs

    Time frame: At the enrollment

    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.

  2. Behavioral intentions

    Time frame: At the enrollment

    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).

  3. Recall and behavioral outcomes at 2-week follow-up

    Time frame: at 2 weeks

    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).

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • Hanoi University of Public Health

Registry information

Official study title

Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.