Health-Related Quality of Life and Metabolic Outcomes in PCOS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention Group.
- Who it may be relevant to
- Registry conditions: PCOS (Polycystic Ovary Syndrome). Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
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.
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.
Interventions
- Other Intervention Group
Short term comprehensive PCOS education coupled with lifestyle modification support
Primary outcome measures
- Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants. [Time frame: 4 months]
Secondary outcome measures (3)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT07571915 · 26-396