- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07812545
Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
8. september 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
2000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zachary Massey, PhD
- Telefonnummer: (405) 271-6872
- E-mail: zachary-massey@ou.edu
Studiesteder
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- Rekruttering
- University of Oklahoma Health Campus, Health Promotion Research Center
-
Kontakt:
- Zachary Massey, PhD
- Telefonnummer: 405-271-6872
- E-mail: zachary-massey@ou.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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).
|
|
Eksperimentel: 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.
|
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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk perceptions of alcohol harms (questionnaire self-report)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Attention to warning statements (questionnaire self-report)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. juli 2026
Primær færdiggørelse (Anslået)
1. september 2026
Studieafslutning (Anslået)
1. september 2026
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
8. september 2026
Først opslået (Faktiske)
10. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 18774
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .