Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome
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Purpose
| Condition |
|---|
|
Polycystic Ovary Syndrome Dietary Habits Physical Activity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS) |
- Differences in diet between women with and without PCOS [ Time Frame: 1 week ] [ Designated as safety issue: No ]A food frequency questionnaire will be administered to assess diet composition for the last three months.
- Differences in exercise between women with and without PCOS [ Time Frame: 1 week ] [ Designated as safety issue: No ]An accelerometer will be administered to assess physical activity for 1 week.
- Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]A questionnaire will be administered to assess psychosocial factors of women with PCOS.
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 | |
| 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 |
| Study First Received: | May 17, 2013 |
| Last Updated: | May 25, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cornell University:
|
Polycystic Ovary Syndrome (PCOS) Diet Exercise Questionnaires Health Beliefs |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016