MeDiApp-PCOS: A Mobile Mediterranean Diet App for Women With Polycystic Ovary Syndrome

NCT07598344 | Not Yet Recruiting

• 1 other identifier: 125042105343-8
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (9)

• Change in fasting insulin and HOMA-IR from baseline to 3 months

  Baseline (Visit 1) and Month 3 (Visit 2)

• Change in triglycerides and HDL cholesterol from baseline to 3 months

  Baseline (Visit 1) and Month 3 (Visit 2)

• Proportion of participants achieving at least 5% weight loss at 3 months

  Baseline (Visit 1) and Month 3 (Visit 2)

• Change in total testosterone, free androgen index, androstenedione and SHBG from baseline to 3 months

  Baseline (Visit 1) and Month 3 (Visit 2)

• Change in inflammatory markers from baseline to 3 months

  Baseline (Visit 1) and Month 3 (Visit 2)

Study Arms (2)

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.

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.

Behavioral: Standard Lifestyle Advice for PCOS

Interventions

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.

Standard Lifestyle Advice

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.

Mobile Application With Personalized Mediterranean Diet-Based Recommendations

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health: lead

Related Links

• Related Info

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Polina Popova, MD Phd

CONTACT

+79217424404; popova_pv@almazovcentre.ru

Elena Vasukova

CONTACT

+79811727490; elenavasukova2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share