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NCT Number: NCT07571915

Health-Related Quality of Life and Metabolic Outcomes in PCOS

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
  • 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

Treatment and study plan

Intervention group

Other

Short term comprehensive PCOS education coupled with lifestyle modification support

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Sike

CONTACT

[email protected]

216-444-7551

Andrea Parianos

CONTACT

[email protected]

216-445-8354

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • American Academy of Family Physicians

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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