Actively Recruiting
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
Led by The Cleveland Clinic · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
A
American Academy of Family Physicians
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of a short-term, comprehensive education and lifestyle modification support program for women with Polycystic Ovary Syndrome (PCOS) and obesity. The study focuses on improving health-related quality of life and examines changes in body composition, cardiometabolic, and inflammation biomarkers. The trial is conducted by a multidisciplinary health team using a virtual group format to deliver the intervention. Participants are randomly assigned to either the intervention group, which receives comprehensive PCOS education combined with lifestyle support, or to a standard care group without intervention. The intervention is delivered synchronously online, allowing participants to engage in group sessions focused on managing PCOS through education and lifestyle changes. Assessments including medical body composition analysis, laboratory tests, and questionnaires are performed to gather data. During the study, participants will undergo evaluations at baseline and after four months, including body composition scanning, blood tests for glucose, insulin, and C-reactive protein, and quality of life questionnaires specific to PCOS. The main outcome is the change in PCOS-related quality of life scores after four months. Secondary outcomes include changes in body fat, visceral adiposity index, and metabolic biomarkers. The total study duration for participants is four months, with monitoring conducted remotely via virtual sessions.
CONDITIONS
Brief Title
Health-Related Quality of Life and Metabolic Outcomes in PCOS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 49 years
- Diagnosed with Polycystic Ovary Syndrome and obesity (BMI ≥ 30 kg/m2) at enrollment
- Not pregnant at enrollment
You will not qualify if you...
- Pregnant or planning pregnancy during the study period
- Participated in a PCOS-focused group within the last 12 months
- Documented monogenic obesity
- Diagnosis of any type of diabetes except prediabetes
- On systemic glucocorticoid therapy for more than 7 days at enrollment
- Have end-stage organ disease
- No access to internet
- Require English language interpretation
- Any condition preventing ability to complete the study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to complete eligibility assessments including medical history and BMI measurement
Duration - 4 months
Participants in the intervention group receive short term comprehensive PCOS education and lifestyle modification support delivered via synchronous virtual groups. Participants in the control group complete body composition analysis, lab workup, and questionnaires without intervention.
Weekly virtual group sessions and periodic assessments including body composition analysis and lab work
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Andrea Parianos
A
Amber Sike
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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