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

31. Mai 2026 aktualisiert von: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Mobile 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.
Aktiver Komparator: 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.
Verhalten: Standard 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in LDL cholesterol from baseline to 3 months
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in fasting insulin and HOMA-IR from baseline to 3 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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)
Change in Mediterranean diet adherence score (15-Items Pyramid based Mediterranean Diet Score (PyrMDS)) from baseline to 3 months
Zeitfenster: 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
Baseline (Visit 1) and Month 3 (Visit 2)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

13. Mai 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2028

Studienabschluss (Geschätzt)

30. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 125042105343-8

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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