Status:
COMPLETED
Healthy Eating for Reproductive Health (HERHealth)
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
Academy of Nutrition and Dietetics
Conditions:
Polycystic Ovarian Syndrome
Infertility
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly ...
Detailed Description
This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance, like...
Eligibility Criteria
Inclusion
- Women must meet the following criteria:
- have been attempting pregnancy for at least 6 months
- is not currently pregnant
- has a clinical diagnosis of PCOS
- is not on oral medications for insulin resistance (such as metformin) or, if currently on such a medication, has been on the medication at a stable dose for at least 3 months
- willing not use fertility-enhancing medications over the 6-month study (with the exception of oral medications, such as clomiphene citrate, as directed by their physician)
- willing to be randomized to either dietary condition and able to make weekly meetings.
Exclusion
- Participants should not be in this study if they meet any of the following criteria:
- have not been diagnoses with polycystic ovarian syndrome
- have been trying to conceive less than 6 months
- have a Body Mass Index less than 25 or greater than 45 kg/m2
- are currently pregnant
- are younger than 18 or older than 35 years of age
- are a smoker
- are unable to come to the Columbia, SC area at least 3-4 times in a 6 month time period for assessments
- don't have access to the Internet and a computer
- don't have access to a scale for self-monitoring weight
- aren't willing to be randomized to either group
- have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
- have a major health condition, such as heart conditions, diabetes, and past incidence of stroke
- unable to receive consent from your doctor to participate if you currently are on blood pressure medications, have issues with dizziness, or have bone or joint issues
- have an eating disorder
- currently participating in a weight loss program or taking weight loss medications
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01509066
Start Date
January 1 2012
End Date
June 1 2013
Last Update
April 18 2019
Active Locations (1)
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1
University of South Carolina
Columbia, South Carolina, United States, 29208