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RecruitingInterventional

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

NCT ID: NCT07571915Sponsor: The Cleveland ClinicLast updated: 2026-05-06

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.

Arms & interventions

  • OtherIntervention Group

    Short term comprehensive PCOS education coupled with lifestyle modification support

Outcome measures

Primary

  • 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.

    Time frame: 4 months

Secondary

  • Change in body composition analysis

    Time frame: 4 months

  • Change in visceral adiposity index (VAI)

    Time frame: 4 months

  • Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls.

    Time frame: 4 months

Eligibility criteria

Sex: FemaleAge: 18 Years to 49 YearsHealthy 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

Study locations (1)

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Amber Sike · Contact
216-444-7551sikea@ccf.org
Andrea Parianos · Contact
216-445-8354debsa@ccf.org