Alcohol Labeling Study

NCT ID: NCT06835920

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Front-of-package health warning

Group Type EXPERIMENTAL

Front-of-package health warning

Intervention Type BEHAVIORAL

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.

Control label

Group Type OTHER

Control label

Intervention Type BEHAVIORAL

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

Interventions

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Front-of-package health warning

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.

Intervention Type BEHAVIORAL

Control label

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marissa Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC study office

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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University of North Carolina

Role: primary

919-966-0233

Marissa Hall, PhD

Role: primary

919-445-1310

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01AA030548

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-1218b

Identifier Type: -

Identifier Source: org_study_id

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