Health Risks and Barriers to Management Across the PCOS Lifespan

Trial Title: Health Risks and Barriers to Management Across the PCOS Lifespan

NCT ID: NCT05769426

Condition: Polycystic Ovary Syndrome
Menopause

Conditions: Official terms:
Polycystic Ovary Syndrome

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Cross-Sectional

Summary: The overall objective of the proposed pilot project is to explore health literacy and barriers to management of PCOS across the lifespan and determine whether the cardiometabolic risks of PCOS extend beyond menopause. The investigators hypothesize that barriers to PCOS management exist and cardiometabolic risks for this population are magnified by aging and menopause.

Detailed description: This proposed research serves to provide preliminary data to determine how the metabolic consequences of menopause are exacerbated in women with PCOS. In addition, the investigators will identify barriers to lifestyle management strategies for women with PCOS across the lifespan. The findings will provide preliminary data to inform future interventions to reduce cardiometabolic risk among postmenopausal women with PCOS. Understanding literacy skills and barriers to PCOS management will facilitate the development of personalized, therapeutic strategies and clear communication between patient-health care provider. Furthermore, these practices will help women with PCOS become more involved in their health care decisions and improve women's health. Therefore, our specific aims are twofold: Aim 1. Explore and contrast health literacy and barriers to lifestyle management among reproductive-aged and postmenopausal women with PCOS. Using semi-structured, qualitative interviews and REDCap surveys, the investigators will assess differences in health literacy, self-efficacy, and barriers to lifestyle management practices in groups of women with PCOS who are of reproductive age or post-menopausal. Aim 2. Assess and compare the metabolic risk of women with PCOS to age and BMI-matched, postmenopausal controls. The cohort of post-menopausal women with PCOS in Aim 1 and a cohort of age and BMI-matched post-menopausal women who have no history of hyperandrogenism/PCOS will complete measurement of cardiometabolic risk factors, androgen profile and body composition via dual energy x-ray absorptiometry.

Criteria for eligibility:

Study pop:
Community sample

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - All races and ethnicities - Females who are of reproductive age (18-40 years) [PCOS-PRE only] - Females who are (≥ 50 years) and post-menopausal (no menstruation within the last 12 months) [PCOS-POST and CON-POST only] - Score of 3 or more on Self-administered screener to screen for PCOS and/or diagnosis of PCOS (ICD-10 code E28.2 or other) [PCOS-PRE and PCOS-POST only] - Score of 0-2 on Self-administered screener to screen for PCOS and no self-reported history of PCOS or hyperandrogenism [CON-POST only] - Access to an electronic device that have virtual/video capabilities [PCOS-PRE and PCOS-POST only] - BMI 18.5-40 kg/m2 - Able to read and speak English Exclusion Criteria: - Current smoker - Alcohol abuse - Currently pregnant or lactating - Recent (within 3 years) diagnosis/treatment of cancer (excluding basal cell carcinoma) - Hormone replacement therapy use within the last 3 months - Surgical menopause (Oophorectomy or other surgical cause of menopause) - Prisoner/TDCJ - Any other condition or event considered exclusionary by study PIs

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Texas Medical Branch

Address:
City: Galveston
Zip: 77555
Country: United States

Start date: March 27, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: The University of Texas Medical Branch, Galveston
Agency class: Other

Source: The University of Texas Medical Branch, Galveston

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05769426