Alcohol Labeling Study

Not Applicable

Recruiting

• Conditions: Health Behavior

• Registration Number: NCT06835920
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This study aims to examine the effects of new front-of-package alcohol warnings on alcohol consumption. Participants will be randomly assigned to either new front-of-package health warnings or control labels. Participants will bring in their own alcohol to weekly study visits and take home the alcohol to consume as usual. Participants will receive study labels on their alcohol containers per their assigned trial arm.

Detailed Description

This study aims to determine whether new front-of-package health warnings on alcohol containers lead to less alcohol consumption and improve consumer understanding about the harms of alcohol. We aim to enroll approximately 720 adults ages 21 years and older who report consuming alcohol at least once per week.

After providing informed consent, participants will be randomly assigned to receive new front-of-package health warnings or control labels.

Participants will attend 3 in-person study visits spaced approximately 1 week apart. Participants in the warnings arm will receive a health warning applied to the front of their alcohol containers at each of the weekly visits for a total of 3 unique warnings during the study. Warnings will be applied in counterbalanced order. Participants in the control arm will receive one label during the study.

Participants will report the number of drinks they consumed daily via text message and will complete 4 computer surveys spaced approximately 1 week apart.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-19
• Study Start: 2025-04-28
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Adults ages 21 years and older
• Not identified as having possible alcohol dependence
• Consumed alcohol at least once per week during the past 4 weeks
• At least half of alcohol consumed each week is from store-bought containers
• Willing to bring 8 days' worth of alcohol to 3 in-person study visits
• Not pregnant, breastfeeding, or trying to get pregnant
• Able to take surveys in English
• Willing to respond to text messages daily for 3 weeks
• Not living in the same household as anyone else in the study

Exclusion Criteria

• Not living in US

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of alcoholic drinks consumed	Assessed daily for 21 days, starting the day after enrollment.	Measured using the following item "How many drinks did you have yesterday? If you're not sure, make your best guess. By 'yesterday,' we mean before you went to bed, even if the drinking happened after midnight. One drink is equivalent to a 12-ounce beer, a 5-ounce glass of wine, or a drink with one shot of liquor." Participants will respond with the number of drinks they consumed.

Secondary Outcome Measures

Name	Time	Method
Maximum number of drinks in a day	Assessed daily for 21 days, starting the day after enrollment.	Participants will report the number of drinks they had yesterday using the following item "How many drinks did you have yesterday?" For each participant, researchers will calculate the maximum number of drinks in a day as the highest number of drinks participants report consuming in one day during the study period.
Perceived likelihood of harms from alcohol	Assessed 4 times approximately 1-week apart, starting on the day of enrollment.	Measured using the item: "What is the chance that drinking 2 \[standard drinks of alcohol type\] a day will cause you to have health problems one day?" Participants will answer the question 4 times, once about 4 types of alcohol: beer, wine, hard seltzer, and liquor. Response options are on a 5-point scale ranging from "No chance", coded as 1 to "High chance", coded as 5. Responses to the 4 questions will be averaged. Higher scores indicate greater perceived likelihood of having health problems caused by alcohol.
Intentions to limit drinking	Assessed 4 times approximately 1-week apart, starting on the day of enrollment.	Measured using 3 survey items: 1) "How interested are you in drinking no more than x drinks in the next week?" 2) "How much do you plan to have no more than x drinks in the next week?" and 3) "How likely are you to have no more than x drinks in the next week?" where x = 7 if the participant's sex at birth is female, 14 otherwise. Response options are on a 5-point scale with lowest endorsement coded as 1 and highest endorsement coded as 5. Researchers will average responses to the 3 items. Higher scores indicate greater intentions to limit drinking.
Forgoing a drink	Assessed approximately 1 week, 2 weeks, and 3 weeks after enrollment.	Measured using 5 survey items asking participants how often they chose to forgo a drink during the study (e.g., "In the last 7 days, how often have you stopped yourself from having an alcoholic drink because you wanted to cut back?"). Response options are on a 5-point scale ranging from "Never" coded as 0, to "10 or more times", coded as 10. Researchers will average responses to the 5 items. Higher scores indicate greater frequency of forgoing a drink.
Proportion of days drinking	Assessed daily for 21 days, starting the day after enrollment.	Participants will report the number of drinks they had yesterday using the following item "How many drinks did you have yesterday?" The proportion of days drinking will be calculated as the number of days participants report consuming alcohol during the study divided by the total number of days they report their alcohol consumption during the study. Missing data will be excluded from both the numerator and denominator.
Learning something new	Assessed once, approximately 21 days after enrollment.	Measured using 1 survey item: "Did you learn something new from the labels?" where response options are "Yes" (coded as 1) and "No" (coded as 0).
Reminding of harms of alcohol	Assessed 4 times approximately 1-week apart, starting on the day of enrollment.	Measured using 1 survey item: "How much did the labels remind you that drinking alcohol can be harmful?" Response options are on a 5-point scale ranging from "Not at all", coded as 1 to "A great deal", coded as 5. Higher scores indicate greater reminding of harms of alcohol.
Perceived control over drinking	Assessed approximately 1 week, 2 weeks, and 3 weeks after enrollment.	Measured using 1 survey item: "Did the labels make you feel...?" where response options are "Less in control of your drinking" "Neither less nor more in control of your drinking" and "More in control of your drinking." Responses will be coded as increasing control (1) vs. reducing control or neither increasing nor reducing (0).
Knowledge of harms from alcohol in warnings	Assessed once, approximately 21 days after enrollment.	Measured using 3 survey items: "How does having 2 alcoholic drinks a day affect the risk of \[cancer/ scarring of the liver/ high blood pressure\]?" Response options include "Decreases risk" "No effect" "Increases risk" and "Not sure." Knowledge will be coded as correct if participants select "Increases risk" and incorrect if participants select any other option. Participants will receive a correct overall knowledge score only if they answer all 3 items correctly.
Perceived healthfulness of alcohol	Assessed 4 times approximately 1-week apart, starting on the day of enrollment.	Measured using the item: "How healthy or unhealthy is \[alcohol type\]?" Participants will answer the question 4 times, once about 4 types of alcohol: beer, wine, hard seltzer, and liquor. Response options are on a 5-point scale ranging from "Very unhealthy", coded as 1 to "Very healthy", coded as 5. Responses to the 4 questions will be averaged. Higher scores indicate greater perceived healthfulness of alcohol.

Trial Locations

Locations (2)

UNC study office; 🇺🇸 Chapel Hill, North Carolina, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States