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
The Cleveland Clinic
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.
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
- Age range
- 18–49 years
- Sex
- Female
- 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…
Interventions
- OtherIntervention Group
Short term comprehensive PCOS education coupled with lifestyle modification support
Location
- Cleveland ClinicCleveland, Ohio