Clinical trial · Interventional
Health-Related Quality of Life and Metabolic Outcomes in PCOS
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
NCT07571915CI-TRIAL-00116458recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Participants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries Short term comprehensive PCOS education coupled with lifestyle modification support
- interventionNames
- Other: Intervention Group
Primary outcomes (1)
- measure
- Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants.
- timeFrame
- 4 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.