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

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ClinicalTrials.gov Identifier: NCT01859663
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : January 10, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Polycystic Ovary Syndrome Dietary Habits Physical Activity

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, 80 women (40 women with PCOS, 40 women without PCOS) will be included in this study. 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 and physical activity questionnaire. A researcher may also provide participants with an accelerometer to wear 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, and (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index). 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 Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
Study Start Date : May 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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

Secondary Outcome Measures :
  1. Differences in exercise between women with and without PCOS [ Time Frame: 1 week ]
    An accelerometer will be administered to assess physical activity for 1 week.

  2. Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS [ Time Frame: 1-2 weeks ]
    A questionnaire will be administered to assess psychosocial factors of women with PCOS.

Biospecimen Retention:   Samples With DNA
Whole blood and urine samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
New York State. Must be between 18-38 years, with a BMI of 18.5 kg/m2 or higher.

Inclusion Criteria:

  • Between 18 and 38 years
  • BMI ≥ 18.5 kg/m2
  • In PCOS if: Confirmed PCOS diagnosis from their primary care provider

Exclusion Criteria:

  • Use of oral contraceptives
  • Significant weight changes within the last three months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859663

Contact: Marla E. Lujan, PhD 607-255-3153 MEL245@cornell.edu
Contact: Annie Lin, MS, RD 607-255-5483 AL864@cornell.edu

United States, New York
Human Metabolic Research Unit, Cornell University Recruiting
Ithaca, New York, United States, 14853
Contact: Erica Bender, MSN, CNM    607-255-9417    eb572@cornell.edu   
Principal Investigator: Marla E. Lujan, PhD         
Strong Fertility Center Recruiting
Rochester, New York, United States, 14623
Contact: Lynda Kochman, RN, CCRC    585-273-2995    Lynda_kochman@urmc.rochester.edu   
CRC at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Kathleen Hoeger, MD, MPH         
Sponsors and Collaborators
Cornell University
University of Rochester
Principal Investigator: Marla E. Lujan, PhD Cornell University
More Information

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01859663     History of Changes
Other Study ID Numbers: IRB 1303003665
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Cornell University:
Polycystic Ovary Syndrome (PCOS)
Health Beliefs

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases