MeDiApp-PCOS: A Mobile Mediterranean Diet App for Women With Polycystic Ovary Syndrome

Randomized Controlled Trial of a Mobile Application With Personalized Mediterranean Diet-Based Recommendations in Women With Polycystic Ovary Syndrome

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.

Inclusion Criteria:

• Female participants aged 18 to 45 years.

• Diagnosis of polycystic ovary syndrome (PCOS) with an anovulatory phenotype according to the Rotterdam criteria (2003).

• Oligo-ovulation or anovulation, defined as menstrual cycle length greater than 35 days or fewer than 8 menstrual periods per year, together with at least one of the following:

  • 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.

• Possession of a smartphone compatible with the study application (Android or iOS).

• Ability and willingness to use the mobile application and comply with study procedures.

• Provision of written informed consent before any study-specific procedures are performed.

Exclusion Criteria:

• 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.
• Severe liver disease, including cirrhosis or liver failure.
• Severe renal impairment, defined as estimated glomerular filtration rate less than 30 mL/min/1.73 m2.
• Severe cardiovascular disease, including unstable angina, myocardial infarction within the previous 6 months, or stroke within the previous 6 months.
• Use within the previous 3 months of medications that may affect body weight, carbohydrate metabolism, androgen status, or reproductive function, including metformin, oral contraceptives, antiandrogens, gonadotropin-releasing hormone agonists or antagonists, clomiphene citrate, glucocorticoids, thiazolidinediones, or weight-loss drugs.
• Current or past eating disorders, including anorexia nervosa, bulimia nervosa, or binge eating disorder.
• Mental disorders or cognitive conditions that, in the opinion of the investigator, would preclude safe participation or compliance with study procedures.
• Participation in another clinical trial within the previous 3 months.
• Refusal or inability to provide written informed consent.