An interventional study of Digital Intervention and Metformin in Polycystic Ovary Syndrome, sponsored by Shanghai 10th People's Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment
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.
This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
A mini program-based digital intervention.
Behavioral: Digital Intervention
Traditional metformin monotherapy.
Drug: Metformin
This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.
Traditional metformin monotherapy.
Also known as: Metformin treatment
Homeostasis model assessment of insulin resistance
insulin resistance index
Time frame: 3 months
Anthropometry
body mass index (kg/m2)
Time frame: 3 months
menstrual frequency
number of menstruation in a year
Time frame: 3 months
fasting glucose
fasting glucose（mmol/L)
Time frame: 3 months
fasting insulin
fasting insulin（mmol/L)
Time frame: 3 months
Total cholesterol
Total cholesterol (mmol/L)
Time frame: 3 months
Triglycerides
Triglycerides (mmol/L)
Time frame: 3 months
HDL-c
HDL-c (mmol/L)
Time frame: 3 months
LDL-c
LDL-c (mmol/L)
Time frame: 3 months
total testosterone
total testosterone (nmol/L)
Time frame: 3 months
free testosterone
free testosterone (nmol/L)
Time frame: 3 months
Sex hormone-binding globulin
Sex hormone-binding globulin (nmol/L)
Time frame: 3 months
Androstenedione
Androstenedione (ng/ml)
Time frame: 3 months
Dehydroepiandrosterone
Dehydroepiandrosterone (ug/dl)
Time frame: 3 months
International Physical Activity Questionnaire (IPAQ)
Assess physical activity situation in women with PCOS.
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Assess sleep situation in women with PCOS.
Time frame: 3 months
Hospital Anxiety and Depression Scale (HADS)
To evaluate anxiety and depression in PCOS women.
Time frame: 3 months
Three-Factor Eating Questionnaire (TFEQ-R21)
Assess eating behavior in women with PCOS.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Shanghai 10th People's Hospital