Virtual education and lifestyle program to improve quality of life and metabolic health 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
NA · The Cleveland Clinic · NCT07571915
This program will test a short virtual group education and lifestyle support intervention to see if it improves quality of life and metabolic and inflammation markers in adults with PCOS and obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07571915 on ClinicalTrials.gov |
What this trial studies
This feasibility study will deliver a short-term, evidence-based PCOS education and lifestyle modification curriculum via synchronous virtual group sessions led by a multidisciplinary team. The primary outcome is change in PCOS health-related quality of life, with secondary outcomes including changes in adiposity, cardiometabolic measures, and inflammation biomarkers. Eligible participants are non-pregnant females aged 18–49 with PCOS and a BMI ≥30 kg/m2, while key exclusions include diagnosed diabetes, monogenic obesity, recent participation in PCOS-focused groups, lack of internet access, or need for language interpretation. The design focuses on feasibility and preliminary signals of effect to inform the planning of larger trials.
Who should consider this trial
Good fit: Non-pregnant females aged 18–49 with a preexisting diagnosis of PCOS and a BMI of 30 kg/m2 or higher who can access and participate in scheduled virtual group sessions in English.
Not a fit: Patients who are pregnant or planning pregnancy, have diagnosed diabetes, monogenic obesity, recent participation in a PCOS-focused group, require an interpreter, lack internet access, or have end-stage organ disease are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could improve patients' quality of life and reduce metabolic risk factors while offering a scalable virtual care option for people with PCOS and obesity.
How similar studies have performed: Prior lifestyle and education programs for PCOS have demonstrated improvements in symptoms and metabolic measures, and virtual group delivery has growing supportive evidence, though short-term feasibility protocols remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Andrea Parianos
- Email: debsa@ccf.org
- Phone: 216-445-8354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PCOS