- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07812545
Designing Effective Alcohol Health Warnings: An Experimental Study With Adults in the U.S.
2026년 9월 8일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
2000
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Zachary Massey, PhD
- 전화번호: (405) 271-6872
- 이메일: zachary-massey@ou.edu
연구 장소
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- 모병
- University of Oklahoma Health Campus, Health Promotion Research Center
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연락하다:
- Zachary Massey, PhD
- 전화번호: 405-271-6872
- 이메일: zachary-massey@ou.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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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).
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실험적: 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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Risk perceptions of alcohol harms (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for perceptions of severity and likelihood of negative health effects occurring as a result of alcohol consumption.
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Assessed immediately after stimulus exposure.
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Perceived efficacy to prevent alcohol harms (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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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.
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Assessed immediately after stimulus exposure.
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Attitudes about alcohol consumption (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 7) for attitudes about alcohol consumption.
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Assessed immediately after stimulus exposure.
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Intentions to quit or reduce drinking alcohol (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for intentions to quit or reduce alcohol consumption in the next 6 months.
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Assessed immediately after stimulus exposure.
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Intentions to seek information about alcohol health effects and cancer screenings (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for intentions to seek information about the health effects of alcohol, including cancer screenings.
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Assessed immediately after stimulus exposure.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Attention to warning statements (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) of attention to experimental images.
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Assessed immediately after stimulus exposure.
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Perceived message effectiveness (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) of perceived message effectiveness of health warnings in experimental images.
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Assessed immediately after stimulus exposure.
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Reactance (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) of opposition to the health warning information in experimental images.
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Assessed immediately after stimulus exposure.
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Emotional responses (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for strength of positive to negative feeling/emotions about the experimental images.
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Assessed immediately after stimulus exposure.
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Alcohol product appeal (questionnaire self-report)
기간: Assessed immediately after stimulus exposure.
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Continuous self-report measure (1 to 9) for appeal of products in experimental images.
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Assessed immediately after stimulus exposure.
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Unaided recall (i.e., correctly recalling health effects described in warnings)
기간: Assessed immediately after stimulus exposure.
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Open-ended qualitative recall.
Participants are prompted to describe the health risks of alcohol use mentioned in the experimental images.
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Assessed immediately after stimulus exposure.
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"Masked" recall (i.e., viewing health warning stimuli with messages blurred to prompt recall of specific messages)
기간: Assessed immediately after stimulus exposure.
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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.
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Assessed immediately after stimulus exposure.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 27일
기본 완료 (추정된)
2026년 9월 1일
연구 완료 (추정된)
2026년 9월 1일
연구 등록 날짜
최초 제출
2026년 8월 27일
QC 기준을 충족하는 최초 제출
2026년 9월 8일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 18774
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .