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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. 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. |
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| 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. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention | Behavioral | 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. Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL cholesterol from baseline to 3 months | Serum low-density lipoprotein (LDL) cholesterol concentration measured in mmol/L after an overnight fast | 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 | Body mass index calculated as weight (kg) divided by height (m²) | Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting insulin and HOMA-IR from baseline to 3 months | Fasting serum insulin (μIU/mL) and insulin resistance assessed by HOMA-IR index, calculated as (fasting glucose × fasting insulin) / 22.5. Changes will be calculated as values at 3 months (Visit 2) minus baseline values (Visit 1) | Baseline (Visit 1) and Month 3 (Visit 2) |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Polina Popova, MD Phd | Contact | +79217424404 | popova_pv@almazovcentre.ru | |
| Elena Vasukova | Contact | +79811727490 | elenavasukova2@gmail.com |
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| Label | URL |
|---|---|
| Related Info | View source |
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Prospective, randomized, controlled, parallel-group, open-label study of a mobile application providing personalized Mediterranean diet-based recommendations versus standard lifestyle advice in women with polycystic ovary syndrome, with primary endpoint assessment at 3 months and extended follow-up for ovulatory function up to 6 months.
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| Standard Lifestyle Advice for PCOS | Behavioral | Standard care consisting of written lifestyle recommendations for women with polycystic ovary syndrome. This 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. Participants 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. |
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| Change in triglycerides and HDL cholesterol from baseline to 3 months |
Fasting serum triglycerides and high-density lipoprotein (HDL) cholesterol measured using standard enzymatic methods. Changes will be calculated as values at 3 months (Visit 2) minus baseline (Visit 1). |
| Baseline (Visit 1) and Month 3 (Visit 2) |
| Proportion of participants achieving at least 5% weight loss at 3 months | Percentage of participants with a reduction in body weight of ≥5% from baseline to 3 months. Weight is measured in light clothing without shoes. Proportion will be compared between groups using chi-square or Fisher's exact test. | Baseline (Visit 1) and Month 3 (Visit 2) |
| Serum total testosterone, free androgen index (calculated), androstenedione and sex hormone-binding globulin (SHBG) measured by immunochemiluminescence assays. Changes will be calculated as 3 month values minus baseline values. | Serum total testosterone, free androgen index (calculated), androstenedione and sex hormone-binding globulin (SHBG) measured by immunochemiluminescence assays. Changes will be calculated as 3 month values minus baseline values. | Baseline (Visit 1) and Month 3 (Visit 2) |
| Change in inflammatory markers: IL-5, Il-22, IL-1 RA,MCP-1, CCL-7 from baseline to 3 months | Inflammatory markers measured using standard assays. Changes are defined as 3 month values minus baseline values. | Baseline (Visit 1) and Month 3 (Visit 2) |
| Restoration of regular menstrual cycles during 3-6 months | Proportion of participants who achieve regular menstrual cycles, defined as cycle length 21-35 days, during the period between Month 3 and Month 6 of follow-up. Information will be collected from menstrual calendars reviewed at Visit 3. | From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days) |
| Frequency of ovulatory cycles during 3-6 months | Number and proportion of ovulatory cycles per participant during the period from Month 3 to Month 6. Ovulation will be confirmed by serum progesterone >5 ng/mL on cycle days 21-23 and/or by ultrasound follicle monitoring when indicated. | From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days) |
| Change in Mediterranean diet adherence score (15-Items Pyramid based Mediterranean Diet Score (PyrMDS)) from baseline to 3 months | Final score: 0-15
| Baseline (Visit 1) and Month 3 (Visit 2) |
| Adherence to mobile application use at 3 months (main group only) | Adherence will be assessed as the percentage of days with completed nutrition diaries and the mean Mediterranean diet adherence score calculated automatically by the mobile application over the 3 month period. | From Day 0 to Month 3 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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