Qualitative Interview [ Time Frame: 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 Physical Function (10a) [ Time Frame: 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.
PROMIS Fatigue [ Time Frame: 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 Sleep Disturbance [ Time Frame: 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 Sleep-related Impairment [ Time Frame: 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 Depression [ Time Frame: 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.
PROMIS Anxiety [ Time Frame: 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.
PROMIS Satisfaction with roles and abilities [ Time Frame: 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.
PROMIS Ability to participate in social roles and activity [ Time Frame: 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.
Exercise Self-Efficacy Scale [ Time Frame: 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 [ Time Frame: 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.
Height [ Time Frame: Baseline ]
Height will be assessed with a standardized stadiometer [PCOS-POST and CON-POST cohorts only]
Weight [ Time Frame: Baseline ]
Weight will be assessed with a standardized scale [PCOS-POST and CON-POST cohorts only]
Whole body lean mass [ Time Frame: Baseline ]
Whole body lean mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Appendicular lean mass [ Time Frame: Baseline ]
Appendicular lean mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Total fat mass [ Time Frame: Baseline ]
Total fat mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Visceral fat mass [ Time Frame: Baseline ]
Visceral fat mass will be assessed using segmental dual energy x-ray absorptiometry. [PCOS-POST and CON-POST cohorts only]
Total cholesterol [ Time Frame: Baseline ]
Total cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
LDL cholesterol [ Time Frame: Baseline ]
LDL cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
HDL cholesterol [ Time Frame: Baseline ]
HDL cholesterol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Triglycerides [ Time Frame: Baseline ]
Triglycerides will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Glucose [ Time Frame: Baseline ]
Glucose will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Insulin [ Time Frame: Baseline ]
Insulin will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Hemoglobin A1C [ Time Frame: Baseline ]
Hemoglobin A1C will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Estradiol [ Time Frame: Baseline ]
Estradiol will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Testosterone [ Time Frame: Baseline ]
Testosterone will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Androstenedione [ Time Frame: 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 [ Time Frame: Baseline ]
Sex hormone binding globulin will be assessed from a fasting blood sample collected by study staff. [PCOS-POST and CON-POST cohorts only]
Systolic blood pressure [ Time Frame: Baseline ]
Systolic blood pressure will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Diastolic blood pressure [ Time Frame: Baseline ]
Diastolic blood pressure will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Waist Circumference [ Time Frame: Baseline ]
Waist Circumference will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Hip Circumference [ Time Frame: Baseline ]
Hip Circumference will be assessed by study staff using standard protocols. [PCOS-POST and CON-POST cohorts only]
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
