Treating PCOS With Digital Intervention vs. Metformin

NCT ID: NCT05386706

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2023-09-01

Brief Summary

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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

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

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Intervention

A mini program-based digital intervention.

Group Type EXPERIMENTAL

Digital Intervention

Intervention Type BEHAVIORAL

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

Metformin

Traditional metformin monotherapy.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Traditional metformin monotherapy.

Interventions

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Digital Intervention

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

Intervention Type BEHAVIORAL

Metformin

Traditional metformin monotherapy.

Intervention Type DRUG

Other Intervention Names

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Metformin treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Manna

Director, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Qu, Doctor

Role: STUDY_CHAIR

Shanghai 10th People's Hospital

Locations

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Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Dilimulati D, Shao X, Wang L, Cai M, Zhang Y, Lu J, Wang Y, Liu H, Kuang M, Chen H, Zhang M, Qu S. Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e55883. doi: 10.2196/55883.

Reference Type DERIVED
PMID: 39357046 (View on PubMed)

Other Identifiers

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Digital Intervention PCOS

Identifier Type: -

Identifier Source: org_study_id

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