Health-Related Quality of Life and Metabolic Outcomes in PCOS

April 30, 2026 updated by: The Cleveland Clinic

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Amber Sike
  • Phone Number: 216-444-7551
  • Email: sikea@ccf.org

Study Contact Backup

  • Name: Andrea Parianos
  • Phone Number: 216-445-8354
  • Email: debsa@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
          • Andrea Parianos
          • Phone Number: 216-445-8354
          • Email: debsa@ccf.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries
Experimental: Intervention Group

Participants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries

Short term comprehensive PCOS education coupled with lifestyle modification support
Other: Intervention Group
Short term comprehensive PCOS education coupled with lifestyle modification support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants.
Time Frame: 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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body composition analysis
Time Frame: 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.
4 months
Change in visceral adiposity index (VAI)
Time Frame: 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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

American Academy of Family Physicians

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 23, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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