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Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.

8. September 2026 aktualisiert von: University of Oklahoma
Consuming alcohol is a dose-dependent and modifiable risk factor for breast cancer. Although alcohol consumption contributes to an estimated 16% of breast cancer cases, awareness of the link between alcohol and breast cancer risk remains low. Systematically developed and tested health warnings can support population-based approaches and intervention strategies to decrease alcohol consumption and breast cancer risk. For instance, the U.S. Food and Drug Administration can mandate specific warnings through statements (e.g., "WARNING: This product contains nicotine…") and color graphics depicting the negative health consequences of products that can harm public health, such as tobacco and alcohol. However, health warning statements and graphics should be assessed among intended audiences before implementation. Research has outlined principles for effective health warning statements. This project will test different health warning statements about the health effects of alcohol.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Health warning statements should be assessed for effectiveness among target audiences before implementation as interventions. Research has outlined principles for effective health warning statements. Specifically, health warning statements are effective when they impact mediators of health behavior (e.g., message perceptions, emotional/affective reactions, and resistance to messages) as well as actual behavior. Guided by these assumptions, we will conduct an online randomized clinical trial (RCT) (N=2,000) with US female participants (ages 18 to 65 years) who report consuming alcohol in the past 30 days (i.e., people who currently drink) and young adult female non-drinkers (ages 18-29) to assess how both samples rate different alcohol health warning statements presented in different formats.

Studientyp

Interventionell

Einschreibung (Geschätzt)

2000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
        • Rekrutierung
        • University of Oklahoma Health Campus, Health Promotion Research Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • being between 18 and 65 years of age
  • assigned female at birth
  • self-report having consumed alcohol in the last 30 days for the current drinker groups
  • self-report not having consumed alcohol in the last 30 days for the nondrinker groups
  • live in the US and able to read, speak, and understand English

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Health warning statement evaluations (bottles)
A randomized clinical trial (RCT) cohort of adult participants (18-65) will complete a computer-based survey-experiment during a single study visit (conducted online). They will review a series of hypothetical alcohol products and rate the images.
Verhalten: Health warning statement evaluations (bottles)
The experiment will use a 2 (health warning statement: single-theme statement vs. composite paragraph) x 2 (pictogram: present vs. absent) x 2 (format: alcohol container vs. alcohol advertisement) between- and within-subjects design. The between-subject groups are 2 (health warning statement: single-theme vs. composite message) x 2 (pictogram: present vs. absent), and the within-subjects factor is the format of warning presentation (2 alcohol containers vs. 2 alcohol advertisements).
Experimental: Health warning statement evaluations (ads)
A randomized clinical trial (RCT) cohort of adult participants (18-65) will complete a computer-based survey-experiment during a single study visit (conducted online). They will review a series of hypothetical alcohol products and rate the images.
Verhalten: Health warning statement evaluations (ads)
The experiment will use a 2 (health warning statement: single-theme statement vs. composite paragraph) x 2 (pictogram: present vs. absent) x 2 (format: alcohol container vs. alcohol advertisement) between- and within-subjects design. The between-subject groups are 2 (health warning statement: single-theme vs. composite message) x 2 (pictogram: present vs. absent), and the within-subjects factor is the format of warning presentation (2 alcohol containers vs. 2 alcohol advertisements).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Risk perceptions of alcohol harms (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) for perceptions of severity and likelihood of negative health effects occurring as a result of alcohol consumption.
Assessed immediately after stimulus exposure.
Perceived efficacy to prevent alcohol harms (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) for perceptions of response and self-efficacy to protect against the negative health effects occurring as a result of alcohol consumption.
Assessed immediately after stimulus exposure.
Attitudes about alcohol consumption (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 7) for attitudes about alcohol consumption.
Assessed immediately after stimulus exposure.
Intentions to quit or reduce drinking alcohol (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) for intentions to quit or reduce alcohol consumption in the next 6 months.
Assessed immediately after stimulus exposure.
Intentions to seek information about alcohol health effects and cancer screenings (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) for intentions to seek information about the health effects of alcohol, including cancer screenings.
Assessed immediately after stimulus exposure.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Attention to warning statements (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) of attention to experimental images.
Assessed immediately after stimulus exposure.
Perceived message effectiveness (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.
Assessed immediately after stimulus exposure.
Reactance (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) of opposition to the health warning information in experimental images.
Assessed immediately after stimulus exposure.
Emotional responses (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) for strength of positive to negative feeling/emotions about the experimental images.
Assessed immediately after stimulus exposure.
Alcohol product appeal (questionnaire self-report)
Zeitfenster: Assessed immediately after stimulus exposure.
Continuous self-report measure (1 to 9) for appeal of products in experimental images.
Assessed immediately after stimulus exposure.
Unaided recall (i.e., correctly recalling health effects described in warnings)
Zeitfenster: Assessed immediately after stimulus exposure.
Open-ended qualitative recall. Participants are prompted to describe the health risks of alcohol use mentioned in the experimental images.
Assessed immediately after stimulus exposure.
"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)
Zeitfenster: Assessed immediately after stimulus exposure.
Participants view the 1st image they were exposed to in the experiment with the health warning blurred and are prompted to write down everything they can recall about it.
Assessed immediately after stimulus exposure.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Oklahoma

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Juli 2026

Primärer Abschluss (Geschätzt)

1. September 2026

Studienabschluss (Geschätzt)

1. September 2026

Studienanmeldedaten

Zuerst eingereicht

27. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. September 2026

Zuerst gepostet (Tatsächlich)

10. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 18774

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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