Healthy Eating for Reproductive Health (HERHealth)
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| City: |
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Columbia |
| State: |
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South Carolina |
| Zip Code: |
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29208 |
| Conditions: |
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Polycystic Ovarian Syndrome - Infertility - Obesity - Overweight |
| Purpose: |
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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 by measuring changes in weight. Participants will be randomly
assigned to following one of two dietary approaches for weight loss: 1) a low-calorie
approach to weight loss (reducing caloric intake by approximately 500 calories per day) or
2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any
animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods,
such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be
low-glycemic index, which means you will be asked to favor foods that don't cause a quick
rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast).
Participants will receive counseling and supporting materials on the dietary approach you
are assigned to follow. Both diets are safe and have shown to be effective ways to assist
with achieving a healthy weight. The investigators hypothesize that both groups will see
improvements in weight and fertility with possible greater improvements seen among
participants in the vegan group.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
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
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| NCT ID: |
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NCT01509066 |
| Primary Contact: |
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Principal Investigator
Brie Turner-McGrievy, PhD, MS, RD
University of South Carolina
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbia, South Carolina 29208
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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