Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Academy of Family Physicians | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries | |
| Intervention Group | Experimental | Participants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries Short term comprehensive PCOS education coupled with lifestyle modification support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Other | Short term comprehensive PCOS education coupled with lifestyle modification support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants. | 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition analysis | Change in body composition analysis via seca mBCA (medical Body Composition Analyzer) at four months from baseline among intervention arm participants compared to controls. | 4 months |
| Change in visceral adiposity index (VAI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Parianos | Contact | 216-445-8354 | debsa@ccf.org | |
| Amber Sike | Contact | 216-444-7551 | SIKEA@ccf.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 4 months |
| Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls. | 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 | 4 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |