Health-Related Quality of Life and Metabolic Outcomes in PCOS
Purpose
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.
Condition
- PCOS (Polycystic Ovary Syndrome)
Eligibility
- Eligible Ages
- Between 18 Years and 49 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Standard of Care |
Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries |
|
|
Experimental Intervention Group |
Participants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries Short term comprehensive PCOS education coupled with lifestyle modification support |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic
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.