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NCT Number: NCT07016711

Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle and Nutrition Promotion

Behavioral

Adherence to the Mediterranean diet

Primary outcomes

  1. Adherence to the MedDiet

    Time frame: 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 outcomes

  1. MedDiet adherence levels across different categories of known breast cancer risk factors

    Time frame: At the moment of enrollment

    To assess the frequency of MedDiet adherence levels across different categories of known breast cancer risk factors

  2. Malignant breast lesion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PREVCAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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