Polycystic Ovary Syndrome
Conditions
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.
Interventions
BEHAVIORALDigital Intervention
This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.
DRUGMetformin
Traditional metformin monotherapy.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Homeostasis model assessment of insulin resistance | 3 months | insulin resistance index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| menstrual frequency | 3 months | number of menstruation in a year |
| fasting glucose | 3 months | fasting glucose（mmol/L) |
| fasting insulin | 3 months | fasting insulin（mmol/L) |
| Total cholesterol | 3 months | Total cholesterol (mmol/L) |
| Triglycerides | 3 months | Triglycerides (mmol/L) |
| HDL-c | 3 months | HDL-c (mmol/L) |
| LDL-c | 3 months | LDL-c (mmol/L) |
| total testosterone | 3 months | total testosterone (nmol/L) |
| Anthropometry | 3 months | body mass index (kg/m2) |
| Sex hormone-binding globulin | 3 months | Sex hormone-binding globulin (nmol/L) |
| Androstenedione | 3 months | Androstenedione (ng/ml) |
| Dehydroepiandrosterone | 3 months | Dehydroepiandrosterone (ug/dl) |
| International Physical Activity Questionnaire (IPAQ) | 3 months | Assess physical activity situation in women with PCOS. |
| Pittsburgh Sleep Quality Index (PSQI) | 3 months | Assess sleep situation in women with PCOS. |
| Hospital Anxiety and Depression Scale (HADS) | 3 months | To evaluate anxiety and depression in PCOS women. |
| Three-Factor Eating Questionnaire (TFEQ-R21) | 3 months | Assess eating behavior in women with PCOS. |
| free testosterone | 3 months | free testosterone (nmol/L) |
Countries
China
Outcome results
None listed