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

NCT06818786 | Completed

• 1 other identifier: H25022
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Attitudes and beliefs

  At the enrollment

• Behavioral intentions

  At the enrollment

• Recall and behavioral outcomes at 2-week follow-up

  at 2 weeks

Study Arms (5)

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

Interventions

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 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 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 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 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

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 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

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 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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Georgia State University: lead
• Hanoi University of Public Health: collaborator

Study Sites (1)

Hanoi University of Public Health

Hanoi, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: August 24, 2024
• Primary Completion: September 24, 2024
• Study Completion: October 8, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

VN (1)