Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening

Not yet recruiting

• Conditions: Breast Cancer Prevention

• Registration Number: NCT07016711
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 35000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to the MedDiet	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.

Secondary Outcome Measures

Name	Time	Method
MedDiet adherence levels across different categories of known breast cancer risk factors	At the moment of enrollment	To assess the frequency of MedDiet adherence levels across different categories of known breast cancer risk factors
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	The presence of malignant breast lesion in a subgroup of women participating in mammographic screenings