Clinical trial NCT06835920: Alcohol Labeling Study
Official title: Alcohol Labeling Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-02-19
Enrollment: 720
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of alcoholic drinks consumed
timeFrame: Assessed daily for 21 days, starting the day after enrollment.
Secondary outcomes:
measure: Intentions to limit drinking
timeFrame: Assessed 4 times approximately 1-week apart, starting on the day of enrollment.
measure: Forgoing a drink
timeFrame: Assessed approximately 1 week, 2 weeks, and 3 weeks after enrollment.
measure: Maximum number of drinks in a day
timeFrame: Assessed daily for 21 days, starting the day after enrollment.
measure: Proportion of days drinking
timeFrame: Assessed daily for 21 days, starting the day after enrollment.
measure: Perceived control over drinking
timeFrame: Assessed approximately 1 week, 2 weeks, and 3 weeks after enrollment.
measure: Learning something new
timeFrame: Assessed once, approximately 21 days after enrollment.
measure: Knowledge of harms from alcohol in warnings
timeFrame: Assessed once, approximately 21 days after enrollment.
measure: Reminding of harms of alcohol
timeFrame: Assessed 4 times approximately 1-week apart, starting on the day of enrollment.
measure: Perceived likelihood of harms from alcohol
timeFrame: Assessed 4 times approximately 1-week apart, starting on the day of enrollment.
measure: Perceived healthfulness of alcohol
timeFrame: Assessed 4 times approximately 1-week apart, starting on the day of enrollment.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC study office
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Marissa Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References: