About this trial
This randomized clinical trial will test whether a mobile application with personalized Mediterranean diet-based recommendations can improve health outcomes in women with polycystic ovary syndrome compared with standard lifestyle advice.
Participants will be assigned to either the mobile application group or the standard lifestyle advice group.
The primary outcomes are change in LDL cholesterol and change in body mass index after 3 months.
Secondary outcomes include changes in metabolic and hormonal measures, quality of life, treatment adherence, and ovulatory function assessed through 6 months.
Eligibility criteria
Qualifiers
Female participants aged 18 to 45 years.
Diagnosis of polycystic ovary syndrome (PCOS) with an anovulatory phenotype according to the Rotterdam criteria (2003).
Clinical and/or biochemical hyperandrogenism.
Polycystic ovarian morphology on ultrasound, defined as at least 20 follicles measuring 2 to 9 mm in either ovary and/or ovarian volume of at least 10 cm3.
Disqualifiers
Pregnancy or breastfeeding at the time of enrollment.
Planning pregnancy during the study period.
Type 1 or type 2 diabetes mellitus.
Other endocrine disorders that may affect reproductive or metabolic function, including Cushing syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, or uncontrolled thyroid disease.
Trial design
Treatments tested in this trial
- Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention
- Standard Lifestyle Advice for PCOS