PCOS (Polycystic Ovary Syndrome)
Conditions
Brief 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.
Interventions
BEHAVIORALMobile 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. 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.
BEHAVIORALStandard Lifestyle Advice for PCOS
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.
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL cholesterol from baseline to 3 months | Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days) | Serum low-density lipoprotein (LDL) cholesterol concentration measured in mmol/L after an overnight fast |
| Change in body mass index (BMI) from baseline to 3 months | Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days) | Body mass index calculated as weight (kg) divided by height (m²) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting insulin and HOMA-IR from baseline to 3 months | Baseline (Visit 1) and Month 3 (Visit 2) | 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) |
| Change in triglycerides and HDL cholesterol from baseline to 3 months | Baseline (Visit 1) and Month 3 (Visit 2) | 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). |
| Proportion of participants achieving at least 5% weight loss at 3 months | Baseline (Visit 1) and Month 3 (Visit 2) | 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. |
| 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) | 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. |
| Change in inflammatory markers: IL-5, Il-22, IL-1 RA,MCP-1, CCL-7 from baseline to 3 months | Baseline (Visit 1) and Month 3 (Visit 2) | Inflammatory markers measured using standard assays. Changes are defined as 3 month values minus baseline values. |
| Restoration of regular menstrual cycles during 3-6 months | From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days) | 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. |
| Frequency of ovulatory cycles during 3-6 months | From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days) | 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. |
| Change in Mediterranean diet adherence score (15-Items Pyramid based Mediterranean Diet Score (PyrMDS)) from baseline to 3 months | Baseline (Visit 1) and Month 3 (Visit 2) | Final score: 0-15 * 0-5 points - Low adherence to the Mediterranean diet * 6-9 points - Moderate adherence to the Mediterranean diet * 10-12 points - Good adherence to the Mediterranean diet * 13-15 points - High adherence to the Mediterranean diet |
| Adherence to mobile application use at 3 months (main group only) | From Day 0 to Month 3 | 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. |
Contacts
CONTACTPolina Popova, MD Phd
CONTACTElena Vasukova
Outcome results
None listed