Clinical trial · Interventional
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
NCT07598344CI-TRIAL-00113471MeDiApp-PCOSnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention | Behavioral | — | UNRESOLVED |
| Standard Lifestyle Advice for PCOS | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mobile Application With Personalized Mediterranean Diet-Based Recommendations
- description
- Participants randomized to this arm will receive access to a mobile application specifically developed for women with polycystic ovary syndrome. The application provides personalized dietary recommendations based on the Mediterranean diet, a system for tracking food intake and physical activity, automated feedback and motivational messages, weekly progress reports, and educational materials on PCOS and healthy lifestyle. Participants will be instructed to use the application daily for 6 months, including completion of nutrition and activity diaries and review of recommendations and feedback.
- interventionNames
- Behavioral: Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention
- type
- ACTIVE_COMPARATOR
- label
- Standard Lifestyle Advice
- description
- Participants randomized to this arm will receive standard written recommendations for lifestyle modification in polycystic ovary syndrome, including principles of the Mediterranean diet, recommended foods and example menus, and physical activity recommendations. They will receive a one-time consultation with a dietitian at baseline with explanation of the recommendations and will be advised to keep a paper diary of nutrition and physical activity during the follow-up period. No access to the mobile application will be provided in this arm.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.