NCT07571915NARecruitingAccepts Healthy Volunteers
Health-Related Quality of Life and Metabolic Outcomes in PCOS
The Cleveland Clinic
Start Date
6/1/2026
Completion Date
12/31/2027
Summary
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.
Detailed Description
The proposed feasibility study seeks to test a short-term intervention focused on comprehensive PCOS (Polycystic Ovarian Syndrome) education and lifestyle modification support. The intervention, which will utilize an evidence-based PCOS curriculum, will be implemented by a multidisciplinary team of health providers via synchronous virtual group format.
Eligibility Criteria
Age Range: 18 years to 49 years
Inclusion Criteria:
1. Non-pregnant females ages 18-49 years
2. Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment
Exclusion Criteria:
1. Patients who are pregnant or planning to become pregnant during the study period
2. Patients currently or with recent participation (\< 12 months at the time of enrollment) in a PCOS-focused group
3. Patients with documented monogenic obesity
4. Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
5. Patients on systemic glucocorticoid therapy \> 7 days at the time of enrollment
6. Patients with any end-stage organ disease
7. Patients without access to internet
8. Patients requiring English language interpretation
9. Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study
Interventions
OTHER
Intervention Group
Conditions
PCOS (Polycystic Ovary Syndrome)
Locations
Cleveland Clinic
Cleveland, Ohio 44195
United States