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

Official title

Randomized Controlled Trial of a Mobile Application With Personalized Mediterranean Diet-Based Recommendations in Women With Polycystic Ovary Syndrome

Overview

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

• Behavioral 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 progr
• Behavioral 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

Primary outcome measures

• 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)]
• 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)]

Secondary outcome measures (9)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07598344 · 125042105343-8

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗