Health Risks and Barriers to Management Across the PCOS Lifespan
- Conditions
- Polycystic Ovary SyndromeMenopause
- Registration Number
- NCT05769426
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Height Baseline Height will be assessed with a standardized stadiometer \[PCOS-POST and CON-POST cohorts only\]
PROMIS Sleep Disturbance Baseline 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.
PROMIS Satisfaction with roles and abilities Baseline 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.
Visceral fat mass Baseline Visceral fat mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]
LDL cholesterol Baseline LDL cholesterol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Hemoglobin A1C Baseline Hemoglobin A1C will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Androstenedione Baseline Androstenedione will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Sex hormone binding globulin Baseline Sex hormone binding globulin will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Qualitative Interview Baseline 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.
\[PCOS-PRE, PCOS-POST groups only\]PROMIS Sleep-related Impairment Baseline 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.
PROMIS Anxiety Baseline 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.
Whole body lean mass Baseline Whole body lean mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]
Total fat mass Baseline Total fat mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]
Total cholesterol Baseline Total cholesterol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Insulin Baseline Insulin will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Testosterone Baseline Testosterone will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Systolic blood pressure Baseline Systolic blood pressure will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]
Diastolic blood pressure Baseline Diastolic blood pressure will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]
Waist Circumference Baseline Waist Circumference will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]
Hip Circumference Baseline Hip Circumference will be assessed by study staff using standard protocols. \[PCOS-POST and CON-POST cohorts only\]
PROMIS Fatigue Baseline 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.
PROMIS Depression Baseline 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.
Exercise Self-Efficacy Scale Baseline 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.
Eating at America's Table Study survey Baseline 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.
Triglycerides Baseline Triglycerides will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
Estradiol Baseline Estradiol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
PROMIS Physical Function (10a) Baseline 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.
HDL cholesterol Baseline HDL cholesterol will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
PROMIS Ability to participate in social roles and activity Baseline 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.
Weight Baseline Weight will be assessed with a standardized scale \[PCOS-POST and CON-POST cohorts only\]
Appendicular lean mass Baseline Appendicular lean mass will be assessed using segmental dual energy x-ray absorptiometry. \[PCOS-POST and CON-POST cohorts only\]
Glucose Baseline Glucose will be assessed from a fasting blood sample collected by study staff. \[PCOS-POST and CON-POST cohorts only\]
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States