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临床试验/NCT07016711
NCT07016711尚未招募不适用

Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening in the "Prevention Caravan" by Komen Italy: a Cross-sectional Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 35,000 人开始时间: 2025年6月最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
35,000
主要终点
Adherence to the MedDiet

研究概览

简要总结

The PREVCAR study is a cross-sectional investigation aimed at evaluating dietary habits among women undergoing breast cancer screening. Specifically, the study focuses on adherence to the Mediterranean diet, a dietary pattern recognized for its potential protective role against chronic diseases, including breast cancer. The PREVCAR study will include approximately 35,000 women aged 18 and older who participate in the "Prevention Caravan" and complete both the breast cancer screening and the MEDAS (Mediterranean Diet Adherence Screener) questionnaire. This 14-item questionnaire measures dietary behavior, with scores reflecting levels of adherence to the Mediterranean diet.

The primary objective of the study is to determine the average MEDAS score among participants. Secondary objectives include analyzing how adherence varies across different known breast cancer risk factors-such as age, menopausal status, hormonal therapy use, and reproductive history-and assessing the prevalence of malignant breast lesions identified through the screening.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who participate in the "Prevention Caravan" program;
  • Women who undergo breast cancer screening, including mammography or breast ultrasound;
  • Women who complete the MEDAS questionnaire.

排除标准

  • Women who do not participate in the "Prevention Caravan" program;
  • Women who participate in the "Prevention Caravan" program but undergo screenings or consultations for conditions other than breast cancer, such as gynecological cancers, thyroid ultrasounds, or dermatological evaluations;
  • Women who do not complete the MEDAS questionnaire.

结局指标

主要结局

Adherence to the MedDiet

时间窗: At the moment of enrollment

To assess adherence to the MedDiet, as measured by the Mediterranean Diet Adherence Screener (MEDAS) questionnaire, among women participating in mammographic screenings organized by the "Prevention Caravan" program. Adherence to the MedDiet was evaluated using the 14-item MEDAS questionnaire (S), a validated tool designed to assess specific dietary behaviors-including the consumption of olive oil, fruits, vegetables, legumes, fish, white meat, and wine-as well as the intake of foods considered inconsistent with the Mediterranean dietary pattern, such as red meat, butter, and sugar-sweetened beverages. Each item is scored as 0 or 1 based on the participant's response, resulting in a total score ranging from 0 to 14. Higher scores indicate greater adherence: scores above 10 are classified as excellent, scores between 8 and 10 as good, and scores below 8 as poor adherence to the MedDiet.

次要结局

  • MedDiet adherence levels across different categories of known breast cancer risk factors(At the moment of enrollment)
  • Malignant breast lesion(After 1 year, when women will be contact by phone to collect follow-up information on the outcomes of their breast screening)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boccia Stefania

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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