Randomized Controlled Trial of a Mobile Application With Personalized Mediterranean Diet-Based Recommendations in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in LDL cholesterol from baseline to 3 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 cm
- •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.
排除标准
- •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 m
- •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.
研究组 & 干预措施
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.
干预措施: Mobile Application-Based Personalized Mediterranean Diet and Lifestyle Intervention (Behavioral)
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.
干预措施: Standard Lifestyle Advice for PCOS (Behavioral)
结局指标
主要结局
Change in LDL cholesterol from baseline to 3 months
时间窗: 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
时间窗: 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)
次要结局
- 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))
- Restoration of regular menstrual cycles during 3-6 months(From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days))
- Frequency of ovulatory cycles during 3-6 months(From Month 3 to Month 6 (assessed at Visit 3, Month 6 ± 7 days))
- Change in Mediterranean diet adherence score from baseline to 3 months(Baseline (Visit 1) and Month 3 (Visit 2))
- Adherence to mobile application use at 3 months (main group only)(From Day 0 to Month 3)