Health-Related Quality of Life and Metabolic Outcomes in PCOS

NCT07571915 | Recruiting DMC

• 1 other identifier: 26-296
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in body composition analysis

  4 months

• Change in visceral adiposity index (VAI)

  4 months

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

  4 months

Study Arms (2)

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

Other: Intervention Group

Interventions

Intervention Group OTHER

Short term comprehensive PCOS education coupled with lifestyle modification support

Intervention Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant females ages 18-49 years
• Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment

You may not qualify if:

• Patients who are pregnant or planning to become pregnant during the study period
• Patients currently or with recent participation (\< 12 months at the time of enrollment) in a PCOS-focused group
• Patients with documented monogenic obesity
• Patients on systemic glucocorticoid therapy \> 7 days at the time of enrollment
• Patients with any end-stage organ disease
• Patients without access to internet
• Patients requiring English language interpretation
• Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Academy of Family Physicians: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Andrea Parianos

CONTACT

216-445-8354; debsa@ccf.org

Amber Sike

CONTACT

216-444-7551; SIKEA@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): May 23, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)