[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638857":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":26,"overallStatus":63,"whyStopped":26,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":26},{"fullName":5,"class":6},"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mobile Application With Personalized Mediterranean Diet-Based Recommendations","EXPERIMENTAL","Participants randomized to this arm will receive access to a mobile application specifically developed for women with polycystic ovary syndrome.\n\nThe 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.\n\nParticipants will be instructed to use the application daily for 6 months, including completion of nutrition and activity diaries and review of recommendations and feedback.",[13],"Behavioral: Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Lifestyle Advice","ACTIVE_COMPARATOR","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.\n\nThey 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.\n\nNo access to the mobile application will be provided in this arm.",[19],"Behavioral: Standard Lifestyle Advice for PCOS",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention","The intervention consists of a mobile application providing personalized Mediterranean diet-based nutrition plans, a food database with nutritional information, automatic calculation of caloric intake and macronutrient composition, monitoring of adherence to the Mediterranean diet, physical activity recommendations (including minimum weekly minutes of moderate aerobic activity and strength training), an activity diary with step tracking, automated feedback and motivational messages, weekly progress reports, push notifications with reminders, and educational materials on PCOS and healthy lifestyle.\n\nParticipants are instructed to use the application daily for 6 months, to enter food intake and physical activity, and to review personalized feedback. The intervention aims to optimize dietary habits, increase physical activity, improve metabolic parameters, and support restoration of ovulatory function in women with PCOS.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Lifestyle Advice for PCOS","Standard care consisting of written lifestyle recommendations for women with polycystic ovary syndrome.\n\nThis includes printed materials describing the Mediterranean diet (principles, recommended and discouraged foods, example menus), physical activity recommendations, and general educational information on PCOS and the importance of lifestyle changes.\n\nParticipants will receive a one-time dietitian consultation at baseline to review the recommendations and will be advised to keep a paper diary of nutrition and physical activity throughout the follow-up period. No digital application or additional feedback system will be provided.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Polina Popova, MD Phd","CONTACT","+79217424404","popova_pv@almazovcentre.ru",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Elena Vasukova","+79811727490","elenavasukova2@gmail.com",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100638857","mediapp-pcos-a-mobile-mediterranean-diet-app-for-women-with-polycystic-ovary-syndrome-100638857",false,"NCT07598344","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","MeDiApp-PCOS","Inclusion Criteria:\n\n* Female participants aged 18 to 45 years.\n* Diagnosis of polycystic ovary syndrome (PCOS) with an anovulatory phenotype according to the Rotterdam criteria (2003).\n* 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:\n\n  * Clinical and\u002For biochemical hyperandrogenism.\n  * Polycystic ovarian morphology on ultrasound, defined as at least 20 follicles measuring 2 to 9 mm in either ovary and\u002For ovarian volume of at least 10 cm3.\n* Possession of a smartphone compatible with the study application (Android or iOS).\n* Ability and willingness to use the mobile application and comply with study procedures.\n* Provision of written informed consent before any study-specific procedures are performed.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding at the time of enrollment.\n* Planning pregnancy during the study period.\n* Type 1 or type 2 diabetes mellitus.\n* Other endocrine disorders that may affect reproductive or metabolic function, including Cushing syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, or uncontrolled thyroid disease.\n* Severe liver disease, including cirrhosis or liver failure.\n* Severe renal impairment, defined as estimated glomerular filtration rate less than 30 mL\u002Fmin\u002F1.73 m2.\n* Severe cardiovascular disease, including unstable angina, myocardial infarction within the previous 6 months, or stroke within the previous 6 months.\n* 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.\n* Current or past eating disorders, including anorexia nervosa, bulimia nervosa, or binge eating disorder.\n* Mental disorders or cognitive conditions that, in the opinion of the investigator, would preclude safe participation or compliance with study procedures.\n* Participation in another clinical trial within the previous 3 months.\n* Refusal or inability to provide written informed consent.","FEMALE","18 Years","45 Years",{"count":55,"type":56},60,"ESTIMATED","INTERVENTIONAL",[59],"NA","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.\n\nParticipants will be assigned to either the mobile application group or the standard lifestyle advice group.\n\nThe primary outcomes are change in LDL cholesterol and change in body mass index after 3 months.\n\nSecondary outcomes include changes in metabolic and hormonal measures, quality of life, treatment adherence, and ovulatory function assessed through 6 months.",[62],"PCOS (Polycystic Ovary Syndrome)","NOT_YET_RECRUITING","2026-05-31",{"date":66,"type":67},"2026-06-03","ACTUAL",{"date":69,"type":56},"2026-05-13",{"date":71,"type":56},"2029-06-30",{"name":5,"class":6}]