PCOS (Polycystic Ovary Syndrome)
Conditions
Brief 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.
Interventions
OTHERIntervention Group
Short term comprehensive PCOS education coupled with lifestyle modification support
Sponsors
The Cleveland Clinic
American Academy of Family Physicians
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition analysis | 4 months | Change in body composition analysis via seca mBCA (medical Body Composition Analyzer) at four months from baseline among intervention arm participants compared to controls. |
| Change in visceral adiposity index (VAI) | 4 months | Change in visceral adiposity index (VAI) via at four months from baseline among intervention arm participants compared to controls. A reliable indicator of visceral fat function associated with cardiometabolic risk. Sex-specific index, based on waist circumference, BMI, triglycerides, and HDL cholesterol, indirectly expressing visceral fat function. |
| Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls. | 4 months | Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls. Fasting glucose units - mg/dL Fasting insulin units - mU/mL C-reactive protein - mg/L |
Countries
United States
Contacts
CONTACTAndrea Parianos
CONTACTAmber Sike
Outcome results
None listed