PCOS (Polycystic Ovary Syndrome)MeDiApp-PCOSNCT07598344
MeDiApp-PCOS: A Mobile Mediterranean Diet App for Women With Polycystic Ovary Syndrome
A study testing Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention and Standard Lifestyle Advice for PCOS in people with PCOS (Polycystic Ovary Syndrome), run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention and Standard Lifestyle Advice for PCOS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Trial of a Mobile Application With Personalized Mediterranean Diet-Based Recommendations in Women With Polycystic Ovary Syndrome
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
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention, Standard Lifestyle Advice for PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application-Based Personalized Mediterranean Diet and Lifestyle InterventionBehavioural
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.
Standard Lifestyle Advice for PCOSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention |
| 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. Receives: Behavioral: Standard Lifestyle Advice for PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL cholesterol from baseline to 3 months
Serum low-density lipoprotein (LDL) cholesterol concentration measured in mmol/L after an overnight fast
Measured: 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)
Measured: Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days)
Secondary outcomes (9)
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)
Measured: Baseline (Visit 1) and Month 3 (Visit 2)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- 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
Measured: 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.
Measured: From Day 0 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 May 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598344
- Sponsor's protocol ID
- 125042105343-8
- Acronym
- MeDiApp-PCOS
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Mobile Application With Personalized Mediterranean Diet-Based Recommendations in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07598344
- Acronym / sponsor ID
- MeDiApp-PCOS / 125042105343-8
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 13 May 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mobile Application With Personalized Mediterranean Diet-Based Recommendations | Experimental | Behavioral: Mobile Application-Based Personalized Mediterranean Diet and Lifestyle InterventionParticipants 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. |
| Standard Lifestyle Advice | Active comparator | Behavioral: Standard Lifestyle Advice for PCOSParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Application-Based Personalized Mediterranean Diet and Lifestyle InterventionThe 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. | Behavioural | Mobile Application With Personalized Mediterranean Diet-Based Recommendations |
| Standard Lifestyle Advice for PCOSStandard 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. | Behavioural | Standard Lifestyle Advice |
Primary outcome
Change in LDL cholesterol from baseline to 3 months
Time frame: 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
Time frame: 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)
9 secondary outcomes
Change in fasting insulin and HOMA-IR from baseline to 3 months
Time frame: Baseline (Visit 1) and Month 3 (Visit 2)
Change in triglycerides and HDL cholesterol from baseline to 3 months
Time frame: Baseline (Visit 1) and Month 3 (Visit 2)
Proportion of participants achieving at least 5% weight loss at 3 months
Time frame: 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.
Time frame: 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
Time frame: Baseline (Visit 1) and Month 3 (Visit 2)
Restoration of regular menstrual cycles during 3-6 months
Time frame: From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days)
Frequency of ovulatory cycles during 3-6 months
Time frame: 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
Time frame: Baseline (Visit 1) and Month 3 (Visit 2)
Adherence to mobile application use at 3 months (main group only)
Time frame: From Day 0 to Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention and Standard Lifestyle Advice for PCOS in people with PCOS (Polycystic Ovary Syndrome), run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Polina Popova, MD Phd (+79217424404, popova_pv@almazovcentre.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL cholesterol from baseline to 3 months (time frame: Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.