Health Risks and Barriers to Management Across the PCOS Lifespan

NCT05769426 | Completed

• 1 other identifier: 23-0011
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Menopause

Outcome Measures

Primary Outcomes (32)

• Qualitative Interview

  A virtual platform (ie. Zoom) will be used to conduct semi-structured interviews, which are expected to last approximately 60 minutes. Scripting will be followed to limit variability and ensure measurements are applied similarly across the entire study period. Open-ended questions will be included in the script that will query participants about topics such as barriers to behaviors, facilitators (intrapersonal and environmental), self-efficacy and health literacy. \[PCOS-PRE, PCOS-POST groups only\]

  Baseline

• PROMIS Physical Function (10a)

  The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'. The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates average physical function. A higher T-score indicates higher than average physical function, while a lower T-score indicates lower than average physical function.

  Baseline

• PROMIS Fatigue

  The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates average fatigue. A higher T-score indicates higher than average fatigue, while a lower T-score indicates lower than average fatigue.

  Baseline

• PROMIS Sleep Disturbance

  The PROMIS Sleep Disturbance questionnaire has 4 questions that ask participants about their perceptions of sleep quality, sleep depth, and restoration associated with sleep in the last 7 days on a five point scale from 'not at all' to 'very much'. The score of each question are summed and then used to generate a T-score. A T-score of 50 indicates average sleep disturbance. A higher T-score indicates higher than average sleep disturbance, while a lower T-score indicates lower than average sleep disturbance.

  Baseline

• PROMIS Sleep-related Impairment

  The PROMIS Sleep-related Impairment questionnaire has 4 questions that ask participants about alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness in the last 7 days on a five point scale from 'not at all' to 'very much'.A T-score of 50 indicates average sleep related impairment. A higher T-score indicates higher than average sleep impairment, while a lower T-score indicates lower than average sleep impairment.

  Baseline

• PROMIS Depression

  The PROMIS Emotional Distress-Depression questionnaire has 4 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days. A T-score of 50 indicates average depressive symptoms. A higher T-score indicates higher than average depressive symptoms, while a lower T-score indicates lower than average depressive symptoms.

  Baseline

• PROMIS Anxiety

  The PROMIS Anxiety questionnaire has 8 questions that asks participants about feelings of fear, worry, dread, tension, nervousness, restlessness, racing heart, dizziness with a five point scale from 'never' to 'always' over the past 7 days. A T-score of 50 indicates average anxiety. A higher T-score indicates higher than average anxiety while a lower T-score indicates lower than average sleep anxiety.

  Baseline

• PROMIS Satisfaction with roles and abilities

  The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'. A T-score of 50 indicates average satisfaction. A higher T-score indicates higher than average satisfaction, while a lower T-score indicates lower than average satisfaction.

  Baseline

• PROMIS Ability to participate in social roles and activity

  The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'. A T-score of 50 indicates average ability to participate. A higher T-score indicates higher than average ability to participate, while a lower T-score indicates lower than average ability to participate.

  Baseline

• Exercise Self-Efficacy Scale

  The Exercise Self-Efficacy Scale is an 8-item questionnaire that assesses the participant's belief in their future ability to exercise three times per week at a moderate intensity for 40= min (upper end of their perceived exertion range) per session. A higher score indicates a greater belief to exercise.

  Baseline

• Eating at America's Table Study survey

  The Eating at America's Table Study survey is 10 question survey that asks participants to recall the fruits and vegetables they ate last month and then report the frequency of consumption on a ten point scale from never up to 5 or more times per day. A higher score indicates a higher consumption of fruits and vegetables.

  Baseline

• Height

  Height will be assessed with a standardized stadiometer \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Weight

  Weight will be assessed with a standardized scale \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Whole body lean mass

  Whole body lean mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Appendicular lean mass

  Appendicular lean mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Total fat mass

  Total fat mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Visceral fat mass

  Visceral fat mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Total cholesterol

  Total cholesterol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• LDL cholesterol

  LDL cholesterol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• HDL cholesterol

  HDL cholesterol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Triglycerides

  Triglycerides will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Glucose

  Glucose will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Insulin

  Insulin will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Hemoglobin A1C

  Hemoglobin A1C will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Estradiol

  Estradiol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Testosterone

  Testosterone will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Androstenedione

  Androstenedione will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Sex hormone binding globulin

  Sex hormone binding globulin will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Systolic blood pressure

  Systolic blood pressure will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Diastolic blood pressure

  Diastolic blood pressure will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Waist Circumference

  Waist Circumference will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

• Hip Circumference

  Hip Circumference will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]

  Baseline

Other Outcomes (2)

• Clot stability

  Baseline

• Platelet function

  Baseline

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (\< 30 ml) will be collected from a single venipuncture which will be analyzed for cardiometabolic and hormonal profile.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Emily Lantz, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: March 27, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)