Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Georgia State University
- Enrollment
- 1,010
- Locations
- 1
- Primary Endpoint
- Emotional and cognitive responses
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Branded pack with the current set of PHWs covering 50% of the pack without quitline information
Intervention: Branded pack with the current set of PHWs 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
Intervention: Branded pack with new PHWs covering 50% of the pack without quitline information (Other)
Plain pack with new PHWs covering 85% of the pack with quitline information
Intervention: Plain pack with new PHWs 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
Intervention: Branded pack with new PHWs covering 85% of the pack with quitline information (Other)
Branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information
Intervention: Branded pack with new PHWs covering 85% of the pack without quitline information (Other)
Outcomes
Primary Outcomes
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
- Attitudes and beliefs(At the enrollment)
- Behavioral intentions(At the enrollment)
- Recall and behavioral outcomes at 2-week follow-up(at 2 weeks)
Investigators
Thi Phuong Thao Tran
Principal Investigator
Georgia State University