Not Yet RecruitingNot Applicable

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

60 participantsStarted 2026-05-13

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses a mobile app to guide women with PCOS toward a Mediterranean diet — is my current diet and lifestyle situation a good fit for a study that's entirely focused on eating changes rather than medication?
2The trial is measuring LDL cholesterol and BMI over just 3 months — is that timeframe long enough to make a meaningful difference for my specific PCOS symptoms, or would a longer or different approach suit me better right now?
3Since this study hasn't started recruiting yet, how long might it be before I could actually join, and should I be starting some other treatment in the meantime rather than waiting?
4This trial is listed as Phase NA, which typically means it's a behavioral or lifestyle intervention rather than a drug trial — does that change how you'd weigh the potential benefits and risks compared to a medication-based option for my PCOS?
5Are there standard PCOS treatment guidelines around diet and lifestyle that I should try first, and would starting those now affect whether I might be eligible for this study later?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in LDL cholesterol from baseline to 3 months

Timeframe: Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days)

Change in body mass index (BMI) from baseline to 3 months

Timeframe: Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days)

Trial details

NCT IDNCT07598344

SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Polina Popova, MD Phd

+79217424404 popova_pv@almazovcentre.ru

View on ClinicalTrials.gov More PCOS (Polycystic Ovary Syndrome) trials