RecruitingNot ApplicableNCT07571915
Health-Related Quality of Life and Metabolic Outcomes in PCOS
Health-Related Quality of Life and Metabolic Outcomes in PCOS: A Feasibility Study of Comprehensive PCOS Education and Lifestyle Modification Support Delivered Via Synchronous Virtual Groups
Sponsor
The Cleveland Clinic
Enrollment
40 participants
Start Date
May 23, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years
Inclusion Criteria2
- 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 Criteria9
- 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
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Interventions
OTHERIntervention Group
Short term comprehensive PCOS education coupled with lifestyle modification support
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07571915
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