WithdrawnNot Applicable

Healthy Eating for Reproductive Health: Greenville

Stopped: No participants were recruited over the course of the study time period

United States0Started 2012-10

Plain-language 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 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.

Who can participate

Age range18 Years – 35 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

What they're measuring

Changes in body weight

Timeframe: 6 months

Trial details

NCT IDNCT01716429

SponsorUniversity of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09