NCT07571915 · The Cleveland Clinic
Health-Related Quality of Life and Metabolic Outcomes in PCOS
What this study is about
The primary outcome of interest is change in PCOS health-related quality of life, while the secondary outcome of interest is change in adiposity, cardiometabolic, and inflammation biomarkers.
View original scientific description
The primary outcome of interest is change in PCOS health-related quality of life, while the secondary outcome of interest is change in adiposity, cardiometabolic, and inflammation biomarkers.
Interventions
OTHER
Intervention Group
Short term comprehensive PCOS education coupled with lifestyle modification support
Primary outcome measures
Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants.
Time frame: 4 months
Change in Polycystic ovarian Syndrome (PCOS) health-related quality of life assessed via the Modified PCOS Health-Related Quality of Life questionnaire (mPCOSQ) at two months and four months from baseline among intervention arm participants compared to controls. Scale Range: The instrument uses a 7-point scale, where lower scores (e.g., 1) represent a high negative impact on quality of life, and higher scores (e.g., 7) represent better quality of life.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Non-pregnant females ages 18-49 years
- Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment
Exclusion criteria
- Patients who are pregnant or planning to become pregnant during the study period
- Patients currently or with recent participation (\< 12 months at the time of enrollment) in a PCOS-focused group
- Patients with documented monogenic obesity
- Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
- Patients on systemic glucocorticoid therapy \> 7 days at the time of enrollment
- Patients with any end-stage organ disease
- Patients without access to internet
- Patients requiring English language interpretation
- Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study
Where
- Cleveland, Ohio
Collaborators
American Academy of Family Physicians
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations