Health Risks and Barriers to Management Across the PCOS Lifespan

NCT ID: NCT05769426

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2024-09-30

Brief 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.

Conditions

Polycystic Ovary Syndrome; Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

PCOS-PRE

20 pre-menopausal women who have been diagnosed with polycystic ovarian syndrome (PCOS) will be recruited for this cohort. Participants in this group will complete a semi-structured virtual interview about barriers to healthy behaviors, self-efficacy and health literacy. The will also complete a battery of surveys related to following domains: sleep, anxiety, depression, satisfaction, physical activity, and dietary habits.

No interventions assigned to this group

PCOS-POST

20 post-menopausal women who have been diagnosed with polycystic ovarian syndrome (PCOS) will be recruited to this cohort. Participants in this group will complete a semi-structured virtual interview and a battery of surveys related to following domains: sleep, anxiety, depression, satisfaction, physical activity, and dietary habits. They will also complete a single in-person visit to the University of Texas Medical Branch where they will undergo a DEXA scan, anthropometric measurements and blood draw.

No interventions assigned to this group

CON-POST

20 post-menopausal women who have not been diagnosed with polycystic ovarian syndrome (PCOS) will be recruited for this cohort. Participants in this group will complete a battery of surveys related to following domains: sleep, anxiety, depression, satisfaction, physical activity, and dietary habits. They will also complete a single in-person visit to the University of Texas Medical Branch where they will undergo a DEXA scan, anthropometric measurements and blood draw.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Lantz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

23-0011

Identifier Type: -

Identifier Source: org_study_id