MeDiApp-PCOS: A Mobile Mediterranean Diet App for Women With Polycystic Ovary Syndrome (MeDiApp-PCOS)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Polina Popova, MD Phd
- Telefoonnummer: +79217424404
- E-mail: popova_pv@almazovcentre.ru
Studie Contact Back-up
- Naam: Elena Vasukova
- Telefoonnummer: +79811727490
- E-mail: elenavasukova2@gmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Mobile Application With Personalized Mediterranean Diet-Based Recommendations
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. |
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. |
|
Actieve vergelijker: Standard Lifestyle Advice
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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in LDL cholesterol from baseline to 3 months
Tijdsspanne: 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
|
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
Tijdsspanne: 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)
|
Baseline (Visit 1, Day 0) and Month 3 (Visit 2, Month 3 ± 7 days)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in fasting insulin and HOMA-IR from baseline to 3 months
Tijdsspanne: 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) |
Baseline (Visit 1) and Month 3 (Visit 2)
|
|
Change in triglycerides and HDL cholesterol from baseline to 3 months
Tijdsspanne: 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). |
Baseline (Visit 1) and Month 3 (Visit 2)
|
|
Proportion of participants achieving at least 5% weight loss at 3 months
Tijdsspanne: 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. |
Baseline (Visit 1) and Month 3 (Visit 2)
|
|
Restoration of regular menstrual cycles during 3-6 months
Tijdsspanne: 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. |
From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days)
|
|
Frequency of ovulatory cycles during 3-6 months
Tijdsspanne: 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. |
From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days)
|
|
Adherence to mobile application use at 3 months (main group only)
Tijdsspanne: 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.
|
From Day 0 to Month 3
|
|
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.
Tijdsspanne: 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. |
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
Tijdsspanne: Baseline (Visit 1) and Month 3 (Visit 2)
|
Inflammatory markers measured using standard assays.
Changes are defined as 3 month values minus baseline values.
|
Baseline (Visit 1) and Month 3 (Visit 2)
|
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Change in Mediterranean diet adherence score (15-Items Pyramid based Mediterranean Diet Score (PyrMDS)) from baseline to 3 months
Tijdsspanne: Baseline (Visit 1) and Month 3 (Visit 2)
|
Final score: 0-15
|
Baseline (Visit 1) and Month 3 (Visit 2)
|
Medewerkers en onderzoekers
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Meer informatie
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Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 125042105343-8
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