Health-Related Quality of Life and Metabolic Outcomes in PCOS

N/ARecruitingNCT07571915

The Cleveland Clinic40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

PCOS (Polycystic Ovary Syndrome)

Interventions

Intervention GroupOTHER

Short term comprehensive PCOS education coupled with lifestyle modification support

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

Change in body composition analysis

Change in body composition analysis via seca mBCA (medical Body Composition Analyzer) at four months from baseline among intervention arm participants compared to controls.

Time frame: 4 months

Change in visceral adiposity index (VAI)

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.

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.

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

Time frame: 4 months

Central Contacts

Andrea Parianos

CONTACT

216-445-8354 debsa@ccf.org

Amber Sike

CONTACT

216-444-7551 SIKEA@ccf.org

Data from ClinicalTrials.gov

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