NCT06835920

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Apr 2025Aug 2026

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

February 14, 2025

Last Update Submit

March 18, 2026

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (1)

  • Number of alcoholic drinks consumed

    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.

    Assessed daily for 21 days, starting the day after enrollment.

Secondary Outcomes (10)

  • Intentions to limit drinking

    Assessed 4 times approximately 1-week apart, starting on the day of enrollment.

  • Forgoing a drink

    Assessed approximately 1 week, 2 weeks, and 3 weeks after enrollment.

  • Maximum number of drinks in a day

    Assessed daily for 21 days, starting the day after enrollment.

  • Proportion of days drinking

    Assessed daily for 21 days, starting the day after enrollment.

  • Perceived control over drinking

    Assessed approximately 1 week, 2 weeks, and 3 weeks after enrollment.

  • +5 more secondary outcomes

Study Arms (2)

Front-of-package health warning

EXPERIMENTAL
Behavioral: Front-of-package health warning

Control label

OTHER
Behavioral: Control label

Interventions

Front-of-package health warningBEHAVIORAL

Participants will receive 3 different health warnings about alcohol consumption. The warnings will discuss health risks of alcohol including cancer, high blood pressure, and scarring of the liver. Labels will be placed on the front of participants' alcohol containers.

Front-of-package health warning
Control labelBEHAVIORAL

Participants will receive a label displaying a barcode. Labels will be placed on the front of participants' alcohol containers.

Control label

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Not living in US

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNC study office

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marissa Hall, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

April 28, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)