Treating PCOS With Digital Intervention vs. Metformin

Study Overview
=================
Brief Summary
-----------------
With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

Detailed Description
-----------------
This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Official Title
-----------------
Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Behavioral: Digital Intervention
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance Exclusion Criteria: Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Intervention<br>A mini program-based digital intervention. | Behavioral: Digital Intervention<br>* This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.<br>|
| Active Comparator: Metformin<br>Traditional metformin monotherapy. | Drug: Metformin<br>* Traditional metformin monotherapy.<br>* Other names: Metformin treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis model assessment of insulin resistance | insulin resistance index | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometry | body mass index (kg/m2) | 3 months | 
| menstrual frequency | number of menstruation in a year | 3 months | 
| fasting glucose | fasting glucose（mmol/L) | 3 months | 
| fasting insulin | fasting insulin（mmol/L) | 3 months | 
| Total cholesterol | Total cholesterol (mmol/L) | 3 months | 
| Triglycerides | Triglycerides (mmol/L) | 3 months | 
| HDL-c | HDL-c (mmol/L) | 3 months | 
| LDL-c | LDL-c (mmol/L) | 3 months | 
| total testosterone | total testosterone (nmol/L) | 3 months | 
| free testosterone | free testosterone (nmol/L) | 3 months | 
| Sex hormone-binding globulin | Sex hormone-binding globulin (nmol/L) | 3 months | 
| Androstenedione | Androstenedione (ng/ml) | 3 months | 
| Dehydroepiandrosterone | Dehydroepiandrosterone (ug/dl) | 3 months | 
| International Physical Activity Questionnaire (IPAQ) | Assess physical activity situation in women with PCOS. | 3 months | 
| Pittsburgh Sleep Quality Index (PSQI) | Assess sleep situation in women with PCOS. | 3 months | 
| Hospital Anxiety and Depression Scale (HADS) | To evaluate anxiety and depression in PCOS women. | 3 months | 
| Three-Factor Eating Questionnaire (TFEQ-R21) | Assess eating behavior in women with PCOS. | 3 months |