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Adherence to the Mediterranean Diet Among Women Attending Mammographic Screening

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07016711
Acronym
PREVCAR
Enrollment
35000
Registered
2025-06-12
Start date
2025-06-30
Completion date
2030-05-31
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Prevention

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.

Interventions

BEHAVIORALLifestyle and Nutrition Promotion

Adherence to the Mediterranean diet

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to the MedDietAt the moment of enrollmentTo 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

MeasureTime frameDescription
MedDiet adherence levels across different categories of known breast cancer risk factorsAt the moment of enrollmentTo assess the frequency of MedDiet adherence levels across different categories of known breast cancer risk factors
Malignant breast lesionAfter 1 year, when women will be contact by phone to collect follow-up information on the outcomes of their breast screeningThe presence of malignant breast lesion in a subgroup of women participating in mammographic screenings

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026