- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159647
Consumer Responses to Alcohol Warnings
February 9, 2024 updated by: Anna Grummon, Stanford University
The primary objective is to evaluate whether alcohol warnings about different topics elicit higher perceived message effectiveness than control messages.
The secondary objective is to evaluate whether alcohol warnings about different topics elicit higher reactance than control messages.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Mouth cancer warning
- Behavioral: Throat cancer warning
- Behavioral: Voice box (larynx) warning
- Behavioral: Esophagus cancer warning
- Behavioral: Liver cancer warning
- Behavioral: Colon and rectum cancer warning
- Behavioral: Breast cancer
- Behavioral: Cancer (generic, not site-specific)
- Behavioral: Addiction and neurological changes
- Behavioral: Hypertension
- Behavioral: Liver damage
- Behavioral: Harm to fetus
- Behavioral: Dementia
- Behavioral: Impaired sleep
- Behavioral: Drinking guidelines
- Behavioral: Control
- Behavioral: Road injuries
Detailed Description
Participants will complete a within-subjects online randomized experiment in which they will view and rate messages on the risk of alcohol consumption.
Participants will view and rate 12 messages total: 10 warning messages and 2 control messages.
They will rate each message on perceived message effectiveness (primary outcome) and message reactance (secondary outcome).
The 10 warning messages will be about 5 different warning topics (i.e., 2 messages per topic) and the 2 control messages will be about 1 control topic (2 messages per topic).
In this within-subjects experiment, the survey will present the topics in random order and the messages within each topic in random order.
Study Type
Interventional
Enrollment (Actual)
2522
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Online study
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 21 and older
- Reside in the United States
- Able to complete a survey in English
Exclusion Criteria:
- Under 21 years of age
- Reside outside the United States
- Unable to complete a survey in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alcohol Messages
Participants view 12 messages: 10 messages related to health topics (2 messages for each of 5 randomly selected health topics from among all health topics) and 2 control messages.
|
Participants will view messages about the risk of mouth cancer from alcohol consumption.
Participants will view messages about the risk of throat cancer from alcohol consumption.
Participants will view messages about the risk of voice box (larynx) cancer from alcohol consumption.
Participants will view messages about the risk of esophagus cancer from alcohol consumption.
Participants will view messages about the risk of liver cancer from alcohol consumption.
Participants will view messages about the risk of colon and rectum cancer from alcohol consumption.
Participants will view messages about the risk of breast cancer from alcohol consumption.
Participants will view messages about the risk of cancer (not site-specific) from alcohol consumption.
Participants will view messages about the risk of addiction and neurological changes from alcohol consumption.
Participants will view messages about the risk of hypertension from alcohol consumption.
Participants will view messages about the risk of liver damage from alcohol consumption.
Participants will view messages about the risk of harm to a fetus from alcohol consumption during pregnancy.
Participants will view messages about the risk of dementia from alcohol consumption.
Participants will view messages about the risk of impaired sleep from alcohol consumption.
Participants will view messages about guidelines for alcohol consumption.
Participants will view neutral messages unrelated to the harms of alcohol consumption.
Participants will view messages about the risk of road injuries from alcohol consumption.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived message effectiveness
Time Frame: The survey will take up to 20 minutes.
|
The study will assess perceived message effectiveness using 1 item: "How much does this message discourage you from wanting to drink alcohol?" Response options will range from "not at all" (coded as 1) to "a great deal" (coded as 5).
Higher scores indicate more perceived message effectiveness.
|
The survey will take up to 20 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reactance
Time Frame: The survey will take up to 20 minutes.
|
The study will assess reactance using 1 item: "Say how much you disagree or agree with this statement: This message exaggerates the health effects of alcohol."
Response options will range from "strongly disagree" (coded as 1) to "strongly agree" (coded as 5).
Higher scores indicate more reactance.
|
The survey will take up to 20 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Grummon, PhD, Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2024
Primary Completion (Actual)
January 26, 2024
Study Completion (Actual)
January 26, 2024
Study Registration Dates
First Submitted
November 27, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 7, 2023
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Investigators will post de-identified individual participant data in a publicly available repository.
IPD Sharing Time Frame
Investigators will post IDP upon acceptance of any manuscripts associated with the data generated in this study.
IPD Sharing Access Criteria
Data and code will be publicly available.
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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