Alcohol DrinkingNCT06159647
Consumer Responses to Alcohol Warnings
A study testing Mouth cancer warning, Throat cancer warning and Voice box (larynx) warning in people with Alcohol Drinking, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Mouth cancer warning, Throat cancer warning and Voice box (larynx) warning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,522 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 and older
- Reside in the United States
- Able to complete a survey in English
Who cannot join
- Under 21 years of age
- Reside outside the United States
- Unable to complete a survey in English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Mouth cancer warning, Throat cancer warning, Voice box (larynx) warning, Esophagus cancer warning, Liver cancer warning
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth cancer warningBehavioural
Participants will view messages about the risk of mouth cancer from alcohol consumption.
Throat cancer warningBehavioural
Participants will view messages about the risk of throat cancer from alcohol consumption.
Voice box (larynx) warningBehavioural
Participants will view messages about the risk of voice box (larynx) cancer from alcohol consumption.
Esophagus cancer warningBehavioural
Participants will view messages about the risk of esophagus cancer from alcohol consumption.
Liver cancer warningBehavioural
Participants will view messages about the risk of liver cancer from alcohol consumption.
Colon and rectum cancer warningBehavioural
Participants will view messages about the risk of colon and rectum cancer from alcohol consumption.
Breast cancerBehavioural
Participants will view messages about the risk of breast cancer from alcohol consumption.
Cancer (generic, not site-specific)Behavioural
Participants will view messages about the risk of cancer (not site-specific) from alcohol consumption.
Addiction and neurological changesBehavioural
Participants will view messages about the risk of addiction and neurological changes from alcohol consumption.
HypertensionBehavioural
Participants will view messages about the risk of hypertension from alcohol consumption.
Liver damageBehavioural
Participants will view messages about the risk of liver damage from alcohol consumption.
Harm to fetusBehavioural
Participants will view messages about the risk of harm to a fetus from alcohol consumption during pregnancy.
DementiaBehavioural
Participants will view messages about the risk of dementia from alcohol consumption.
Impaired sleepBehavioural
Participants will view messages about the risk of impaired sleep from alcohol consumption.
Drinking guidelinesBehavioural
Participants will view messages about guidelines for alcohol consumption.
ControlBehavioural
Participants will view neutral messages unrelated to the harms of alcohol consumption.
Road injuriesBehavioural
Participants will view messages about the risk of road injuries from alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Messages | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived message effectiveness
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.
Measured: The survey will take up to 20 minutes.
Secondary outcomes (1)
Reactance
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.
Measured: The survey will take up to 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start18 Jan 2024
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Grummon, Stanford University
- Investigators
- Anna Grummon, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159647
- Sponsor's protocol ID
- 71682
- Status last verified
- Feb 2024
- First submitted
- 27 Nov 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will post de-identified individual participant data in a publicly available repository.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Responses to Alcohol Warnings
- ClinicalTrials.gov ID
- NCT06159647
- Acronym / sponsor ID
- 71682
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,522 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol Messages | Experimental | 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 injuriesParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 and older
- Reside in the United States
- Able to complete a survey in English
Key exclusion criteria (3 listed)
- Under 21 years of age
- Reside outside the United States
- Unable to complete a survey in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouth cancer warningParticipants will view messages about the risk of mouth cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Throat cancer warningParticipants will view messages about the risk of throat cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Voice box (larynx) warningParticipants will view messages about the risk of voice box (larynx) cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Esophagus cancer warningParticipants will view messages about the risk of esophagus cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Liver cancer warningParticipants will view messages about the risk of liver cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Colon and rectum cancer warningParticipants will view messages about the risk of colon and rectum cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Breast cancerParticipants will view messages about the risk of breast cancer from alcohol consumption. | Behavioural | Alcohol Messages |
| Cancer (generic, not site-specific)Participants will view messages about the risk of cancer (not site-specific) from alcohol consumption. | Behavioural | Alcohol Messages |
| Addiction and neurological changesParticipants will view messages about the risk of addiction and neurological changes from alcohol consumption. | Behavioural | Alcohol Messages |
| HypertensionParticipants will view messages about the risk of hypertension from alcohol consumption. | Behavioural | Alcohol Messages |
| Liver damageParticipants will view messages about the risk of liver damage from alcohol consumption. | Behavioural | Alcohol Messages |
| Harm to fetusParticipants will view messages about the risk of harm to a fetus from alcohol consumption during pregnancy. | Behavioural | Alcohol Messages |
| DementiaParticipants will view messages about the risk of dementia from alcohol consumption. | Behavioural | Alcohol Messages |
| Impaired sleepParticipants will view messages about the risk of impaired sleep from alcohol consumption. | Behavioural | Alcohol Messages |
| Drinking guidelinesParticipants will view messages about guidelines for alcohol consumption. | Behavioural | Alcohol Messages |
| ControlParticipants will view neutral messages unrelated to the harms of alcohol consumption. | Behavioural | Alcohol Messages |
| Road injuriesParticipants will view messages about the risk of road injuries from alcohol consumption. | Behavioural | Alcohol Messages |
Primary outcome
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.
1 secondary outcome
Reactance
Time frame: The survey will take up to 20 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Yes. Investigators will post de-identified individual participant data in a publicly available repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Grummon, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth cancer warning, Throat cancer warning and Voice box (larynx) warning in people with Alcohol Drinking, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived message effectiveness (time frame: The survey will take up to 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.