Clinical trial NCT07016711: Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening
Official title: Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening in the "Prevention Caravan" by Komen Italy: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Prevention
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 35000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will focus on women aged 18 and older who will participate in mammographic screenings organized by the "Prevention Caravan" and who, due to age or other factors, are not eligible for breast cancer screening programs through the National Health Service (NHS). These screenings are primarily offered to women experiencing social or economic hardship, such as those living in suburban areas of Italian cities, women in detention, prison staff, and women residing in shelters. However, the program is also open to all women who exceed the age limits set by regional screening programs. Awareness of the "Prevention Caravan" program raises through advertising campaigns, making it accessible to a wider audience, and participants can easily register online. A total of 35,000 women will be enrolled.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adherence to the MedDiet
timeFrame: At the moment of enrollment
Secondary outcomes:
measure: MedDiet adherence levels across different categories of known breast cancer risk factors
timeFrame: At the moment of enrollment
measure: Malignant breast lesion
timeFrame: After 1 year, when women will be contact by phone to collect follow-up information on the outcomes of their breast screening
Other outcomes:
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