Healthy Eating for Reproductive Health: Greenville
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies, Infertility |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 10/3/2013 |
| Start Date: | October 2012 |
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 the consumer 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 the
participants 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.
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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