Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome

Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)

The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Physical Activity; Dietary Habits

Detailed Description

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. Currently, there is limited knowledge on the current lifestyles of women with PCOS and the psychosocial factors associated with PCOS.

The researchers plan to examine potential lifestyle differences and psychosocial factors between PCOS and healthy women. The Research Team is also interested in the relationships between biological markers and lifestyle endpoints in women with and without PCOS. Previous literature has shown there are biological marker differences between those with and without PCOS. By examining these relationships, researchers may further understand whether PCOS status is associated with lifestyle parameters.

To accomplish these objectives, 360 women (120 women with PCOS, 120 women without PCOS and with normal menstrual cycles, and 120 women without PCOS and with irregular menstrual cycles) will be included in this study. An equal number of lean and overweight/obese women will be recruited within each group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). Women will be included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care provider. Participants will complete a food frequency questionnaire, a sleep questionnaire, and a physical activity questionnaire. A researcher may also provide participants with a waist-worn accelerometer to monitor physical activity and a wrist-worn accelerometer to monitor sleep for a week. Ultrasound scans of the ovaries will be assessed and the following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test; (2) dual X-ray absorptiometry (DXA) scan; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate; (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index); and (5) an (optional) subcutaneous fat biopsy. Women with and without PCOS will also be asked to complete a questionnaire that will assess the psychosocial factors (e.g., health beliefs). This can be conducted online, in person, or through phone.

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

• Study Contact: Name: Marla E. Lujan, PhD; Phone Number: 607-255-3153; Email: MEL245@cornell.edu

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14853
      • Human Metabolic Research Unit, Cornell University
    • Rochester, New York, United States, 14623
      • Strong Fertility Center
    • Rochester, New York, United States, 14642
      • CRC at University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

New York State. Must be between 18-48 years, with a BMI of 18 kg/m2 or higher.

Description

Inclusion Criteria:

• Between 18 and 48 years
• BMI ≥ 18 kg/m2
• If ≥ 21 years old, must have completed a pelvic exam in the past 2 years
• In PCOS if: Confirmed PCOS diagnosis from their primary care provider

Exclusion Criteria:

• Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function
• Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Women with a past diagnosis of PCOS; We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).
Women with a history of regular menstrual cycles; We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).
Women with a history of irregular menstrual cycles; We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in diet between women with and without PCOS	A food frequency questionnaire will be administered to assess diet composition for the last three months.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Androgen concentrations	Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.	1 day
LH-FSH ratio	The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups	1 day
Menstrual Cycle Length	Average menstrual cycle length as determined by self-reported history will be determined and compared across groups	1 day
Differences in exercise between women with and without PCOS	An accelerometer will be administered to assess physical activity for 1 week.	1 week
Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS	A questionnaire will be administered to assess psychosocial factors of women with PCOS.	1-2 weeks
Differences in sleep patterns between women with and without PCOS	A wrist-worn accelerometer will be administered to assess sleep patterns for 6 consecutive nights.	6 consecutive nights
Hirsutism Score	Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups	1 day
Body Mass Index	The ratio of weight to height will be determined and compared across groups.	1 day
Waist-to-Hip Ratio	The ratio of waist circumference to hip circumference will be determined and compared across groups	1 day
Ovarian Volume	The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups.	1 day
Insulin Sensitivity	Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups.	1 day
Serum progesterone concentration	The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups.	1 day
Blood pressure	Blood pressure will be determined and compared between groups.	1 day
Serum markers of metabolic syndrome	Lipids, glucose and HbA1C concentrations will be determined and compared between groups.	1 day
Body fat distribution	Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups.	1 day
Subcutaneous fat biopsy (optional)	Subcutaneous fat cells, which represent important sites of reproductive hormone synthesis, will be assessed and compared across groups	1 day

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: University of Rochester
• Investigators: Principal Investigator: Marla E. Lujan, PhD, Cornell University

Publications and helpful links

General Publications

• Lin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: May 17, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimated): May 22, 2013

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Diet; Polycystic Ovary Syndrome (PCOS); Questionnaires; Health Beliefs
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: IRB 1303003665