Clinical trial · Observational
Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome
Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
NCT01859663CI-TRIAL-00073884completedClinicalTrials.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 purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dietary Habits | — | UNRESOLVED | — |
| Physical Activity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Women with a past diagnosis of PCOS
- description
- We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).
- label
- Women with a history of regular menstrual cycles
- description
- We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).
- label
- Women with a history of irregular menstrual cycles
- description
- We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).
Primary outcomes (1)
- measure
- Differences in diet between women with and without PCOS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: * Between 18 and 48 years * BMI ≥ 18 kg/m2 * If ≥ 21 years old, must have completed a pelvic exam in the past 2 years * In PCOS if: Confirmed PCOS diagnosis from their primary care provider Exclusion Criteria: * Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function * Pregnant or breastfeeding
References
Publications (2)
- DERIVEDEvans AT, Rehani E, Smith B, Hong MD, Lewin Z, Hiroshige K, Spandorfer SD, Hajirasouliha I, Lujan ME, Hoeger KM. Diagnosis of Polycystic Ovary Syndrome With Predictive Modeling of Select Clinical Features. O G Open. 2026 Mar 19;3(2):e161. doi: 10.1097/og9.0000000000000161. eCollection 2026 Apr. PMID 41868592
- DERIVEDLin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351. PMID 29182737