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

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

Study Overview

• Status: Completed
• Conditions: Pictorial Health Warnings
• Intervention / Treatment: Other: Branded pack with new PHWs covering 50% of the pack without quitline information; Other: Branded pack with new PHWs covering 85% of the pack with quitline information; Other: Branded pack with new PHWs covering 85% of the pack without quitline information; Other: Plain pack with new PHWs covering 85% of the pack with quitline information; Other: Branded pack with the current set of PHWs covering 50% of the pack without quitline information

• Study Type: Interventional
• Enrollment (Actual): 1010
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Hanoi University of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information	Other: Branded pack with new PHWs covering 50% of the pack without quitline information; 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.
Experimental: Branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information	Other: Branded pack with new PHWs covering 85% of the pack with quitline information; 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
Experimental: Branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information	Other: Branded pack with new PHWs covering 85% of the pack without quitline information; 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.
Experimental: Plain pack with new PHWs covering 85% of the pack with quitline information	Other: Plain pack with new PHWs covering 85% of the pack with quitline information; 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
Active Comparator: Branded pack with the current set of PHWs covering 50% of the pack without quitline information	Other: Branded pack with the current set of PHWs covering 50% of the pack without quitline information; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	at 2 weeks

Collaborators and Investigators

• Sponsor: Georgia State University
• Collaborators: Hanoi University of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2024
• Primary Completion (Actual): September 24, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: H25022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No